beclomethasone profile

ID Source	ID
PubMed CID	20469
CHEMBL ID	1586
CHEBI ID	3001
SCHEMBL ID	3183
MeSH ID	M0002258

Synonym
BIDD:GT0556
MLS001076089 ,
SMP1_000039
BCBCMAP01_000159
beclometason (tn)
D07495
beclometasone (inn)
4419-39-0
C06842
9-chloro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione
beclometasonum
(11beta,16beta)-9-chloro-11,17,21-trihydroxy-16-methylpregna-1,4-diene-3,20-dione
beclometasone
CHEBI:3001 ,
9alpha-chloro-16beta-methylprednisolone
beclometasona
NCGC00164402-01
beclometasonum [inn-latin]
beclometasona [inn-spanish]
einecs 224-585-9
pregna-1,4-diene-3,20-dione, 9-chloro-11,17,21-trihydroxy-16-methyl-, (11beta,16beta)-
beclometasone [inn]
bmj 5800
smr000058899
MLS000028668 ,
(8s,9r,10s,11s,13s,14s,16s,17r)-9-chloro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
CHEMBL1586
dtxcid3020750
dtxsid5040750 ,
cas-4419-39-0
tox21_112116
HMS2233A18
unii-kgz1slc28z
beclometasone [inn:ban]
kgz1slc28z ,
9-chloro-11.beta.,17,21-trihydroxy-16.beta.-methylpregna-1,4-diene-3,20-dione
beclomethasone [mi]
beclometasone propionate
beclometason
beclomethasone [vandf]
beclometasone [who-dd]
gtpl7059
SCHEMBL3183
NCGC00179392-03
tox21_112116_1
NBMKJKDGKREAPL-DVTGEIKXSA-N
CS-5872
HY-B1540
pulvinal
(8s,9r,10s,11s,13s,14s,16s,17r)-9-chloranyl-10,13,16-trimethyl-11,17-bis(oxidanyl)-17-(2-oxidanylethanoyl)-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
bdbm53488
(8s,9r,10s,11s,13s,14s,16s,17r)-9-chloro-11,17-dihydroxy-17-(2-hydroxy-1-oxoethyl)-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
cid_20469
(8s,9r,10s,11s,13s,14s,16s,17r)-9-chloro-17-glycoloyl-11,17-dihydroxy-10,13,16-trimethyl-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
OPERA_ID_1081
9alpha-chloro-11beta,17alpha,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione
sr-01000000273
SR-01000000273-4
AS-58067
9-chloro-11beta,17,21-trihydroxy-16beta-methylpregna-1,4-diene-3,20-dione (beclometasone)
beclometasone; (1r,2s,10s,11s,13s,14r,15s,17s)-1-chloro-14-(2-glycoloyl)-14,17-dihydroxy-2,13,15-trimethyltetracyclo[8.7.0.02,7.011,15]heptadeca-3,6-dien-5-one
AMY7469
gxr ,
(8~{s},9~{r},10~{s},11~{s},13~{s},14~{s},16~{s},17~{r})-9-chloranyl-10,13,16-trimethyl-11,17-bis(oxidanyl)-17-(2-oxidanylethanoyl)-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-3-one
pregna-1,4-diene-3,20-dione,9-chloro-11,17,21-trihydroxy-16-methyl-, (11b,16b)-
A905224
EX-A4423
F85436
AKOS037645177
beclometasone-21-propionate
beclometasone-17-propionate
beclometasona (inn-spanish)
r01ad01
r03ba01
a07ea07
d07ac15
beclometasonum (inn-latin)

Role	Description
anti-inflammatory drug	A substance that reduces or suppresses inflammation.
anti-asthmatic drug	A drug used to treat asthma.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Class	Description
11beta-hydroxy steroid	Any 11-hydroxy steroid in which the hydroxy group at position 11 has beta- configuration.
17alpha-hydroxy steroid	The alpha-stereoisomer of 17-hydroxy steroid.
20-oxo steroid	An oxo steroid carrying an oxo group at position 20.
21-hydroxy steroid
corticosteroid	A natural or synthetic analogue of the hormones secreted by the adrenal gland.
glucocorticoid	Glucocorticoids are a class of steroid hormones that regulate a variety of physiological processes, in particular control of the concentration of glucose in blood.
3-oxo-Delta(1),Delta(4)-steroid	A 3-oxo-Delta(1) steroid containing an additional double bond between positions 4 and 5.
chlorinated steroid	A steroid which is substituted with one or more chlorine atoms in any position.
primary alpha-hydroxy ketone	An alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a -CH2 (methylene) group.
tertiary alpha-hydroxy ketone	An alpha-hydroxy ketone in which the carbonyl group and the hydroxy group are linked by a carbon bearing two organyl groups.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein	Taxonomy	Measurement	Average (µ)	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
pregnane X receptor	Rattus norvegicus (Norway rat)	Potency	3.5481	0.0251	27.9203	501.1870	AID651751
RAR-related orphan receptor gamma	Mus musculus (house mouse)	Potency	23.8675	0.0060	38.0041	19,952.5996	AID1159521; AID1159523
SMAD family member 2	Homo sapiens (human)	Potency	10.6822	0.1737	34.3047	61.8120	AID1346859
SMAD family member 3	Homo sapiens (human)	Potency	10.6822	0.1737	34.3047	61.8120	AID1346859
TDP1 protein	Homo sapiens (human)	Potency	21.1360	0.0008	11.3822	44.6684	AID686978
AR protein	Homo sapiens (human)	Potency	0.0196	0.0002	21.2231	8,912.5098	AID1259243; AID1259247; AID1259381; AID588515; AID743036; AID743040; AID743042; AID743053; AID743054
hypoxia-inducible factor 1, alpha subunit (basic helix-loop-helix transcription factor)	Homo sapiens (human)	Potency	1.0000	0.0013	7.7625	44.6684	AID914; AID915
estrogen receptor 2 (ER beta)	Homo sapiens (human)	Potency	26.6032	0.0006	57.9133	22,387.1992	AID1259378
progesterone receptor	Homo sapiens (human)	Potency	0.0190	0.0004	17.9460	75.1148	AID1346784; AID1347036
cytochrome P450 family 3 subfamily A polypeptide 4	Homo sapiens (human)	Potency	15.8489	0.0123	7.9835	43.2770	AID1346984
glucocorticoid receptor [Homo sapiens]	Homo sapiens (human)	Potency	0.0304	0.0002	14.3764	60.0339	AID588532; AID720691; AID720692; AID720719
retinoic acid nuclear receptor alpha variant 1	Homo sapiens (human)	Potency	20.0372	0.0030	41.6115	22,387.1992	AID1159552; AID1159553; AID1159555
retinoid X nuclear receptor alpha	Homo sapiens (human)	Potency	30.4379	0.0008	17.5051	59.3239	AID1159527; AID1159531; AID588544
estrogen-related nuclear receptor alpha	Homo sapiens (human)	Potency	30.4048	0.0015	30.6073	15,848.9004	AID1224841; AID1224848; AID1224849; AID1259401; AID1259403
pregnane X nuclear receptor	Homo sapiens (human)	Potency	16.1760	0.0054	28.0263	1,258.9301	AID1346982; AID1346985
estrogen nuclear receptor alpha	Homo sapiens (human)	Potency	9.9775	0.0002	29.3054	16,493.5996	AID588513; AID743069; AID743080; AID743091
G	Vesicular stomatitis virus	Potency	17.3768	0.0123	8.9648	39.8107	AID1645842
cytochrome P450 2D6	Homo sapiens (human)	Potency	15.4871	0.0010	8.3798	61.1304	AID1645840
peroxisome proliferator-activated receptor delta	Homo sapiens (human)	Potency	21.8959	0.0010	24.5048	61.6448	AID588534; AID588535
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_a	Homo sapiens (human)	Potency	0.0237	0.0017	23.8393	78.1014	AID743083
thyroid stimulating hormone receptor	Homo sapiens (human)	Potency	29.8493	0.0016	28.0151	77.1139	AID1259385
nuclear factor of kappa light polypeptide gene enhancer in B-cells 1 (p105), isoform CRA_a	Homo sapiens (human)	Potency	8.4852	19.7391	45.9784	64.9432	AID1159509
nuclear receptor subfamily 1, group I, member 2	Rattus norvegicus (Norway rat)	Potency	5.6234	0.1000	9.1916	31.6228	AID1346983
lysosomal alpha-glucosidase preproprotein	Homo sapiens (human)	Potency	5.6234	0.0366	19.6376	50.1187	AID1466; AID2242
nuclear factor erythroid 2-related factor 2 isoform 2	Homo sapiens (human)	Potency	0.0146	0.0041	9.9848	25.9290	AID504444; AID720524
importin subunit beta-1 isoform 1	Homo sapiens (human)	Potency	0.3548	5.8048	36.1306	65.1308	AID540253
snurportin-1	Homo sapiens (human)	Potency	0.3548	5.8048	36.1306	65.1308	AID540253
GTP-binding nuclear protein Ran isoform 1	Homo sapiens (human)	Potency	0.3548	5.8048	16.9962	25.9290	AID540253
nuclear receptor ROR-gamma isoform 1	Mus musculus (house mouse)	Potency	35.4813	0.0079	8.2332	1,122.0200	AID2551
geminin	Homo sapiens (human)	Potency	0.5805	0.0046	11.3741	33.4983	AID624297
survival motor neuron protein isoform d	Homo sapiens (human)	Potency	1.1220	0.1259	12.2344	35.4813	AID1458
Interferon beta	Homo sapiens (human)	Potency	8.7051	0.0033	9.1582	39.8107	AID1347407; AID1645842
HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)	Potency	17.3768	0.0123	8.9648	39.8107	AID1645842
Neuronal acetylcholine receptor subunit alpha-4	Rattus norvegicus (Norway rat)	Potency	5.6234	3.5481	18.0395	35.4813	AID1466
Neuronal acetylcholine receptor subunit beta-2	Rattus norvegicus (Norway rat)	Potency	5.6234	3.5481	18.0395	35.4813	AID1466
TAR DNA-binding protein 43	Homo sapiens (human)	Potency	28.1838	1.7783	16.2081	35.4813	AID652104
Inositol hexakisphosphate kinase 1	Homo sapiens (human)	Potency	17.3768	0.0123	8.9648	39.8107	AID1645842
cytochrome P450 2C9, partial	Homo sapiens (human)	Potency	17.3768	0.0123	8.9648	39.8107	AID1645842
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Protein	Taxonomy	Measurement	Average	Min (ref.)	Avg (ref.)	Max (ref.)	Bioassay(s)
dual specificity protein phosphatase 6	Rattus norvegicus (Norway rat)	IC50 (µMol)	100.0000	0.8320	24.1190	48.2000	AID425
Bile salt export pump	Homo sapiens (human)	IC50 (µMol)	16.9850	0.1100	7.1903	10.0000	AID1443986; AID1449628
Glucocorticoid receptor	Homo sapiens (human)	IC50 (µMol)	0.0082	0.0000	0.4953	10.0000	AID625263
Glucocorticoid receptor	Homo sapiens (human)	Ki	0.0037	0.0001	0.3863	7.0010	AID625263
Glycine receptor subunit alpha-1	Rattus norvegicus (Norway rat)	IC50 (µMol)	0.0082	0.0015	0.7600	5.0740	AID625263
Glycine receptor subunit alpha-1	Rattus norvegicus (Norway rat)	Ki	0.0037	0.0007	0.7653	7.0010	AID625263
Glycine receptor subunit beta	Rattus norvegicus (Norway rat)	IC50 (µMol)	0.0082	0.0015	0.7600	5.0740	AID625263
Glycine receptor subunit beta	Rattus norvegicus (Norway rat)	Ki	0.0037	0.0007	0.7846	7.0010	AID625263
Glycine receptor subunit alpha-2	Rattus norvegicus (Norway rat)	IC50 (µMol)	0.0082	0.0015	0.8044	5.0740	AID625263
Glycine receptor subunit alpha-2	Rattus norvegicus (Norway rat)	Ki	0.0037	0.0007	0.7846	7.0010	AID625263
Glycine receptor subunit alpha-3	Rattus norvegicus (Norway rat)	IC50 (µMol)	0.0082	0.0015	0.7600	5.0740	AID625263
Glycine receptor subunit alpha-3	Rattus norvegicus (Norway rat)	Ki	0.0037	0.0007	0.7846	7.0010	AID625263
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Process	via Protein(s)	Taxonomy
fatty acid metabolic process	Bile salt export pump	Homo sapiens (human)
bile acid biosynthetic process	Bile salt export pump	Homo sapiens (human)
xenobiotic metabolic process	Bile salt export pump	Homo sapiens (human)
xenobiotic transmembrane transport	Bile salt export pump	Homo sapiens (human)
response to oxidative stress	Bile salt export pump	Homo sapiens (human)
bile acid metabolic process	Bile salt export pump	Homo sapiens (human)
response to organic cyclic compound	Bile salt export pump	Homo sapiens (human)
bile acid and bile salt transport	Bile salt export pump	Homo sapiens (human)
canalicular bile acid transport	Bile salt export pump	Homo sapiens (human)
protein ubiquitination	Bile salt export pump	Homo sapiens (human)
regulation of fatty acid beta-oxidation	Bile salt export pump	Homo sapiens (human)
carbohydrate transmembrane transport	Bile salt export pump	Homo sapiens (human)
bile acid signaling pathway	Bile salt export pump	Homo sapiens (human)
cholesterol homeostasis	Bile salt export pump	Homo sapiens (human)
response to estrogen	Bile salt export pump	Homo sapiens (human)
response to ethanol	Bile salt export pump	Homo sapiens (human)
xenobiotic export from cell	Bile salt export pump	Homo sapiens (human)
lipid homeostasis	Bile salt export pump	Homo sapiens (human)
phospholipid homeostasis	Bile salt export pump	Homo sapiens (human)
positive regulation of bile acid secretion	Bile salt export pump	Homo sapiens (human)
regulation of bile acid metabolic process	Bile salt export pump	Homo sapiens (human)
transmembrane transport	Bile salt export pump	Homo sapiens (human)
cell surface receptor signaling pathway via JAK-STAT	Interferon beta	Homo sapiens (human)
response to exogenous dsRNA	Interferon beta	Homo sapiens (human)
B cell activation involved in immune response	Interferon beta	Homo sapiens (human)
cell surface receptor signaling pathway	Interferon beta	Homo sapiens (human)
cell surface receptor signaling pathway via JAK-STAT	Interferon beta	Homo sapiens (human)
response to virus	Interferon beta	Homo sapiens (human)
positive regulation of autophagy	Interferon beta	Homo sapiens (human)
cytokine-mediated signaling pathway	Interferon beta	Homo sapiens (human)
natural killer cell activation	Interferon beta	Homo sapiens (human)
positive regulation of peptidyl-serine phosphorylation of STAT protein	Interferon beta	Homo sapiens (human)
cellular response to interferon-beta	Interferon beta	Homo sapiens (human)
B cell proliferation	Interferon beta	Homo sapiens (human)
negative regulation of viral genome replication	Interferon beta	Homo sapiens (human)
innate immune response	Interferon beta	Homo sapiens (human)
positive regulation of innate immune response	Interferon beta	Homo sapiens (human)
regulation of MHC class I biosynthetic process	Interferon beta	Homo sapiens (human)
negative regulation of T cell differentiation	Interferon beta	Homo sapiens (human)
positive regulation of transcription by RNA polymerase II	Interferon beta	Homo sapiens (human)
defense response to virus	Interferon beta	Homo sapiens (human)
type I interferon-mediated signaling pathway	Interferon beta	Homo sapiens (human)
neuron cellular homeostasis	Interferon beta	Homo sapiens (human)
cellular response to exogenous dsRNA	Interferon beta	Homo sapiens (human)
cellular response to virus	Interferon beta	Homo sapiens (human)
negative regulation of Lewy body formation	Interferon beta	Homo sapiens (human)
negative regulation of T-helper 2 cell cytokine production	Interferon beta	Homo sapiens (human)
positive regulation of apoptotic signaling pathway	Interferon beta	Homo sapiens (human)
response to exogenous dsRNA	Interferon beta	Homo sapiens (human)
B cell differentiation	Interferon beta	Homo sapiens (human)
natural killer cell activation involved in immune response	Interferon beta	Homo sapiens (human)
adaptive immune response	Interferon beta	Homo sapiens (human)
T cell activation involved in immune response	Interferon beta	Homo sapiens (human)
humoral immune response	Interferon beta	Homo sapiens (human)
positive regulation of T cell mediated cytotoxicity	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
adaptive immune response	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class I via ER pathway, TAP-independent	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
regulation of T cell anergy	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
defense response	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
immune response	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
detection of bacterium	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
regulation of interleukin-12 production	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
regulation of interleukin-6 production	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
protection from natural killer cell mediated cytotoxicity	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
innate immune response	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
regulation of dendritic cell differentiation	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
antigen processing and presentation of endogenous peptide antigen via MHC class Ib	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
negative regulation of transcription by RNA polymerase II	Glucocorticoid receptor	Homo sapiens (human)
regulation of gluconeogenesis	Glucocorticoid receptor	Homo sapiens (human)
chromatin organization	Glucocorticoid receptor	Homo sapiens (human)
regulation of DNA-templated transcription	Glucocorticoid receptor	Homo sapiens (human)
apoptotic process	Glucocorticoid receptor	Homo sapiens (human)
chromosome segregation	Glucocorticoid receptor	Homo sapiens (human)
signal transduction	Glucocorticoid receptor	Homo sapiens (human)
glucocorticoid metabolic process	Glucocorticoid receptor	Homo sapiens (human)
gene expression	Glucocorticoid receptor	Homo sapiens (human)
microglia differentiation	Glucocorticoid receptor	Homo sapiens (human)
adrenal gland development	Glucocorticoid receptor	Homo sapiens (human)
regulation of glucocorticoid biosynthetic process	Glucocorticoid receptor	Homo sapiens (human)
synaptic transmission, glutamatergic	Glucocorticoid receptor	Homo sapiens (human)
maternal behavior	Glucocorticoid receptor	Homo sapiens (human)
intracellular glucocorticoid receptor signaling pathway	Glucocorticoid receptor	Homo sapiens (human)
glucocorticoid mediated signaling pathway	Glucocorticoid receptor	Homo sapiens (human)
positive regulation of neuron apoptotic process	Glucocorticoid receptor	Homo sapiens (human)
negative regulation of DNA-templated transcription	Glucocorticoid receptor	Homo sapiens (human)
positive regulation of transcription by RNA polymerase II	Glucocorticoid receptor	Homo sapiens (human)
astrocyte differentiation	Glucocorticoid receptor	Homo sapiens (human)
cell division	Glucocorticoid receptor	Homo sapiens (human)
mammary gland duct morphogenesis	Glucocorticoid receptor	Homo sapiens (human)
motor behavior	Glucocorticoid receptor	Homo sapiens (human)
cellular response to steroid hormone stimulus	Glucocorticoid receptor	Homo sapiens (human)
cellular response to glucocorticoid stimulus	Glucocorticoid receptor	Homo sapiens (human)
cellular response to dexamethasone stimulus	Glucocorticoid receptor	Homo sapiens (human)
cellular response to transforming growth factor beta stimulus	Glucocorticoid receptor	Homo sapiens (human)
neuroinflammatory response	Glucocorticoid receptor	Homo sapiens (human)
positive regulation of miRNA transcription	Glucocorticoid receptor	Homo sapiens (human)
intracellular steroid hormone receptor signaling pathway	Glucocorticoid receptor	Homo sapiens (human)
regulation of transcription by RNA polymerase II	Glucocorticoid receptor	Homo sapiens (human)
negative regulation of protein phosphorylation	TAR DNA-binding protein 43	Homo sapiens (human)
mRNA processing	TAR DNA-binding protein 43	Homo sapiens (human)
RNA splicing	TAR DNA-binding protein 43	Homo sapiens (human)
negative regulation of gene expression	TAR DNA-binding protein 43	Homo sapiens (human)
regulation of protein stability	TAR DNA-binding protein 43	Homo sapiens (human)
positive regulation of insulin secretion	TAR DNA-binding protein 43	Homo sapiens (human)
response to endoplasmic reticulum stress	TAR DNA-binding protein 43	Homo sapiens (human)
positive regulation of protein import into nucleus	TAR DNA-binding protein 43	Homo sapiens (human)
regulation of circadian rhythm	TAR DNA-binding protein 43	Homo sapiens (human)
regulation of apoptotic process	TAR DNA-binding protein 43	Homo sapiens (human)
negative regulation by host of viral transcription	TAR DNA-binding protein 43	Homo sapiens (human)
rhythmic process	TAR DNA-binding protein 43	Homo sapiens (human)
regulation of cell cycle	TAR DNA-binding protein 43	Homo sapiens (human)
3'-UTR-mediated mRNA destabilization	TAR DNA-binding protein 43	Homo sapiens (human)
3'-UTR-mediated mRNA stabilization	TAR DNA-binding protein 43	Homo sapiens (human)
nuclear inner membrane organization	TAR DNA-binding protein 43	Homo sapiens (human)
amyloid fibril formation	TAR DNA-binding protein 43	Homo sapiens (human)
regulation of gene expression	TAR DNA-binding protein 43	Homo sapiens (human)
inositol phosphate metabolic process	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
phosphatidylinositol phosphate biosynthetic process	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
negative regulation of cold-induced thermogenesis	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol phosphate biosynthetic process	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
protein binding	Bile salt export pump	Homo sapiens (human)
ATP binding	Bile salt export pump	Homo sapiens (human)
ABC-type xenobiotic transporter activity	Bile salt export pump	Homo sapiens (human)
bile acid transmembrane transporter activity	Bile salt export pump	Homo sapiens (human)
canalicular bile acid transmembrane transporter activity	Bile salt export pump	Homo sapiens (human)
carbohydrate transmembrane transporter activity	Bile salt export pump	Homo sapiens (human)
ABC-type bile acid transporter activity	Bile salt export pump	Homo sapiens (human)
ATP hydrolysis activity	Bile salt export pump	Homo sapiens (human)
cytokine activity	Interferon beta	Homo sapiens (human)
cytokine receptor binding	Interferon beta	Homo sapiens (human)
type I interferon receptor binding	Interferon beta	Homo sapiens (human)
protein binding	Interferon beta	Homo sapiens (human)
chloramphenicol O-acetyltransferase activity	Interferon beta	Homo sapiens (human)
TAP binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
signaling receptor binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
protein binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
peptide antigen binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
TAP binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
protein-folding chaperone binding	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
RNA polymerase II transcription regulatory region sequence-specific DNA binding	Glucocorticoid receptor	Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA binding	Glucocorticoid receptor	Homo sapiens (human)
DNA-binding transcription factor activity, RNA polymerase II-specific	Glucocorticoid receptor	Homo sapiens (human)
core promoter sequence-specific DNA binding	Glucocorticoid receptor	Homo sapiens (human)
DNA-binding transcription repressor activity, RNA polymerase II-specific	Glucocorticoid receptor	Homo sapiens (human)
DNA-binding transcription activator activity, RNA polymerase II-specific	Glucocorticoid receptor	Homo sapiens (human)
DNA-binding transcription factor activity	Glucocorticoid receptor	Homo sapiens (human)
RNA binding	Glucocorticoid receptor	Homo sapiens (human)
nuclear receptor activity	Glucocorticoid receptor	Homo sapiens (human)
nuclear glucocorticoid receptor activity	Glucocorticoid receptor	Homo sapiens (human)
steroid binding	Glucocorticoid receptor	Homo sapiens (human)
protein binding	Glucocorticoid receptor	Homo sapiens (human)
zinc ion binding	Glucocorticoid receptor	Homo sapiens (human)
TBP-class protein binding	Glucocorticoid receptor	Homo sapiens (human)
protein kinase binding	Glucocorticoid receptor	Homo sapiens (human)
identical protein binding	Glucocorticoid receptor	Homo sapiens (human)
Hsp90 protein binding	Glucocorticoid receptor	Homo sapiens (human)
steroid hormone binding	Glucocorticoid receptor	Homo sapiens (human)
sequence-specific double-stranded DNA binding	Glucocorticoid receptor	Homo sapiens (human)
estrogen response element binding	Glucocorticoid receptor	Homo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA binding	TAR DNA-binding protein 43	Homo sapiens (human)
DNA binding	TAR DNA-binding protein 43	Homo sapiens (human)
double-stranded DNA binding	TAR DNA-binding protein 43	Homo sapiens (human)
RNA binding	TAR DNA-binding protein 43	Homo sapiens (human)
mRNA 3'-UTR binding	TAR DNA-binding protein 43	Homo sapiens (human)
protein binding	TAR DNA-binding protein 43	Homo sapiens (human)
lipid binding	TAR DNA-binding protein 43	Homo sapiens (human)
identical protein binding	TAR DNA-binding protein 43	Homo sapiens (human)
pre-mRNA intronic binding	TAR DNA-binding protein 43	Homo sapiens (human)
molecular condensate scaffold activity	TAR DNA-binding protein 43	Homo sapiens (human)
inositol-1,3,4,5,6-pentakisphosphate kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol hexakisphosphate kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol heptakisphosphate kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol hexakisphosphate 5-kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
protein binding	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
ATP binding	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol hexakisphosphate 1-kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol hexakisphosphate 3-kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol 5-diphosphate pentakisphosphate 5-kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
inositol diphosphate tetrakisphosphate kinase activity	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Process	via Protein(s)	Taxonomy
basolateral plasma membrane	Bile salt export pump	Homo sapiens (human)
Golgi membrane	Bile salt export pump	Homo sapiens (human)
endosome	Bile salt export pump	Homo sapiens (human)
plasma membrane	Bile salt export pump	Homo sapiens (human)
cell surface	Bile salt export pump	Homo sapiens (human)
apical plasma membrane	Bile salt export pump	Homo sapiens (human)
intercellular canaliculus	Bile salt export pump	Homo sapiens (human)
intracellular canaliculus	Bile salt export pump	Homo sapiens (human)
recycling endosome	Bile salt export pump	Homo sapiens (human)
recycling endosome membrane	Bile salt export pump	Homo sapiens (human)
extracellular exosome	Bile salt export pump	Homo sapiens (human)
membrane	Bile salt export pump	Homo sapiens (human)
extracellular space	Interferon beta	Homo sapiens (human)
extracellular region	Interferon beta	Homo sapiens (human)
Golgi membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
endoplasmic reticulum	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
Golgi apparatus	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
plasma membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
cell surface	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
ER to Golgi transport vesicle membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
secretory granule membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
phagocytic vesicle membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
early endosome membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
recycling endosome membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
extracellular exosome	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
lumenal side of endoplasmic reticulum membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
MHC class I protein complex	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
extracellular space	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
external side of plasma membrane	HLA class I histocompatibility antigen, B alpha chain	Homo sapiens (human)
nucleus	Glucocorticoid receptor	Homo sapiens (human)
nucleus	Glucocorticoid receptor	Homo sapiens (human)
nucleoplasm	Glucocorticoid receptor	Homo sapiens (human)
cytoplasm	Glucocorticoid receptor	Homo sapiens (human)
mitochondrial matrix	Glucocorticoid receptor	Homo sapiens (human)
centrosome	Glucocorticoid receptor	Homo sapiens (human)
spindle	Glucocorticoid receptor	Homo sapiens (human)
cytosol	Glucocorticoid receptor	Homo sapiens (human)
membrane	Glucocorticoid receptor	Homo sapiens (human)
nuclear speck	Glucocorticoid receptor	Homo sapiens (human)
synapse	Glucocorticoid receptor	Homo sapiens (human)
chromatin	Glucocorticoid receptor	Homo sapiens (human)
protein-containing complex	Glucocorticoid receptor	Homo sapiens (human)
plasma membrane	Glycine receptor subunit beta	Rattus norvegicus (Norway rat)
intracellular non-membrane-bounded organelle	TAR DNA-binding protein 43	Homo sapiens (human)
nucleus	TAR DNA-binding protein 43	Homo sapiens (human)
nucleoplasm	TAR DNA-binding protein 43	Homo sapiens (human)
perichromatin fibrils	TAR DNA-binding protein 43	Homo sapiens (human)
mitochondrion	TAR DNA-binding protein 43	Homo sapiens (human)
cytoplasmic stress granule	TAR DNA-binding protein 43	Homo sapiens (human)
nuclear speck	TAR DNA-binding protein 43	Homo sapiens (human)
interchromatin granule	TAR DNA-binding protein 43	Homo sapiens (human)
nucleoplasm	TAR DNA-binding protein 43	Homo sapiens (human)
chromatin	TAR DNA-binding protein 43	Homo sapiens (human)
fibrillar center	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
nucleoplasm	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
cytosol	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
nucleus	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
cytoplasm	Inositol hexakisphosphate kinase 1	Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (149)

Assay ID	Title	Year	Journal	Article
AID496828	Antimicrobial activity against Leishmania donovani	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625287	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatomegaly	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588216	FDA HLAED, serum glutamic oxaloacetic transaminase (SGOT) increase	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588214	FDA HLAED, liver enzyme composite activity	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1079946	Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID588219	FDA HLAED, gamma-glutamyl transferase (GGT) increase	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID588217	FDA HLAED, serum glutamic pyruvic transaminase (SGPT) increase	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1449628	Inhibition of human BSEP expressed in baculovirus transfected fall armyworm Sf21 cell membranes vesicles assessed as reduction in ATP-dependent [3H]-taurocholate transport into vesicles incubated for 5 mins by Topcount based rapid filtration method	2012	Drug metabolism and disposition: the biological fate of chemicals, Dec, Volume: 40, Issue:12	Mitigating the inhibition of human bile salt export pump by drugs: opportunities provided by physicochemical property modulation, in silico modeling, and structural modification.
AID1443995	Hepatotoxicity in human assessed as drug-induced liver injury	2014	Hepatology (Baltimore, Md.), Sep, Volume: 60, Issue:3	Human drug-induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump.
AID625282	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cirrhosis	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID678721	Metabolic stability in human liver microsomes assessed as GSH adduct formation at 100 uM after 90 mins by HPLC-MS analysis	2012	Chemical research in toxicology, Oct-15, Volume: 25, Issue:10	Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID625292	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) combined score	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079947	Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID496820	Antimicrobial activity against Trypanosoma brucei	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID497005	Antimicrobial activity against Pneumocystis carinii	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625285	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic necrosis	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625280	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholecystitis	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID588215	FDA HLAED, alkaline phosphatase increase	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1443992	Total Cmax in human administered as single dose	2014	Hepatology (Baltimore, Md.), Sep, Volume: 60, Issue:3	Human drug-induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump.
AID496819	Antimicrobial activity against Plasmodium falciparum	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID625290	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver fatty	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496827	Antimicrobial activity against Leishmania amazonensis	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID678712	Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins	2012	Chemical research in toxicology, Oct-15, Volume: 25, Issue:10	Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID496823	Antimicrobial activity against Trichomonas vaginalis	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID588218	FDA HLAED, lactate dehydrogenase (LDH) increase	2004	Current drug discovery technologies, Dec, Volume: 1, Issue:4	Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling.
AID1079941	Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1079949	Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID524791	Antiplasmodial activity against Plasmodium falciparum 7G8 after 72 hrs by SYBR green assay	2009	Nature chemical biology, Oct, Volume: 5, Issue:10	Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID1079948	Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1079933	Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID521220	Inhibition of neurosphere proliferation of mouse neural precursor cells by MTT assay	2007	Nature chemical biology, May, Volume: 3, Issue:5	Chemical genetics reveals a complex functional ground state of neural stem cells.
AID625279	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for bilirubinemia	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID625289	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver disease	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079945	Animal toxicity known. [column 'TOXIC' in source]
AID678716	Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins	2012	Chemical research in toxicology, Oct-15, Volume: 25, Issue:10	Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID625291	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for liver function tests abnormal	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496817	Antimicrobial activity against Trypanosoma cruzi	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079931	Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1079939	Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID496831	Antimicrobial activity against Cryptosporidium parvum	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496826	Antimicrobial activity against Entamoeba histolytica	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1443991	Induction of mitochondrial dysfunction in Sprague-Dawley rat liver mitochondria assessed as inhibition of mitochondrial respiration per mg mitochondrial protein measured for 20 mins by A65N-1 oxygen probe based fluorescence assay	2014	Hepatology (Baltimore, Md.), Sep, Volume: 60, Issue:3	Human drug-induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump.
AID625281	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for cholelithiasis	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496829	Antimicrobial activity against Leishmania infantum	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079935	Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1443986	Inhibition of recombinant human BSEP expressed in baculovirus infected sf9 cell membrane vesicles assessed as reduction in ATP or AMP-dependent [3H]-taurocholic acid uptake in to vesicles preincubated for 5 mins followed by ATP/AMP addition measured after	2014	Hepatology (Baltimore, Md.), Sep, Volume: 60, Issue:3	Human drug-induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump.
AID496832	Antimicrobial activity against Trypanosoma brucei rhodesiense	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079936	Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1079938	Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
AID496825	Antimicrobial activity against Leishmania mexicana	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID678714	Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins	2012	Chemical research in toxicology, Oct-15, Volume: 25, Issue:10	Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID678722	Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH	2012	Chemical research in toxicology, Oct-15, Volume: 25, Issue:10	Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID409953	Inhibition of mouse liver MAOA	2008	Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21	Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID1079940	Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID625288	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for jaundice	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079934	Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1079944	Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID496821	Antimicrobial activity against Leishmania	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID496824	Antimicrobial activity against Toxoplasma gondii	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID678717	Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins	2012	Chemical research in toxicology, Oct-15, Volume: 25, Issue:10	Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID524796	Antiplasmodial activity against Plasmodium falciparum W2 after 72 hrs by SYBR green assay	2009	Nature chemical biology, Oct, Volume: 5, Issue:10	Genetic mapping of targets mediating differential chemical phenotypes in Plasmodium falciparum.
AID625286	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatitis	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID409954	Inhibition of mouse brain MAOA	2008	Journal of medicinal chemistry, Nov-13, Volume: 51, Issue:21	Quantitative structure-activity relationship and complex network approach to monoamine oxidase A and B inhibitors.
AID678713	Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins	2012	Chemical research in toxicology, Oct-15, Volume: 25, Issue:10	Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID496818	Antimicrobial activity against Trypanosoma brucei brucei	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1079943	Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1079932	Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID625284	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for hepatic failure	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID1079942	Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1079937	Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID678715	Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins	2012	Chemical research in toxicology, Oct-15, Volume: 25, Issue:10	Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID625283	Drug Induced Liver Injury Prediction System (DILIps) training set; hepatic side effect (HepSE) score for elevated liver function tests	2011	PLoS computational biology, Dec, Volume: 7, Issue:12	Translating clinical findings into knowledge in drug safety evaluation--drug induced liver injury prediction system (DILIps).
AID496830	Antimicrobial activity against Leishmania major	2010	Bioorganic & medicinal chemistry, Mar-15, Volume: 18, Issue:6	Multi-target spectral moment QSAR versus ANN for antiparasitic drugs against different parasite species.
AID1347092	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347110	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for A673 cells)	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1508630	Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay	2021	Cell reports, 04-27, Volume: 35, Issue:4	A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347100	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425	Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)	2019	The Journal of biological chemistry, 11-15, Volume: 294, Issue:46	Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347114	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for DAOY cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347082	qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal	2020	Antiviral research, 01, Volume: 173	A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1296008	Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening	2020	SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1	Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347109	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB1643 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083	qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen	2020	Antiviral research, 01, Volume: 173	A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347424	RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)	2019	The Journal of biological chemistry, 11-15, Volume: 294, Issue:46	Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
AID1347126	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh30 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347119	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for MG 63 (6-TG R) cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347086	qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal	2020	Antiviral research, 01, Volume: 173	A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347121	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for control Hh wild type fibroblast cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347104	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347116	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SJ-GBM2 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347412	qHTS assay to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: Counter screen cell viability and HiBit confirmation	2020	ACS chemical biology, 07-17, Volume: 15, Issue:7	High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347127	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Saos-2 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407	qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection	2020	ACS chemical biology, 07-17, Volume: 15, Issue:7	High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347098	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347124	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for RD cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347123	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh41 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347117	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-37 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347122	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for U-2 OS cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347118	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for TC32 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347154	Primary screen GU AMC qHTS for Zika virus inhibitors	2020	Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49	Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1745845	Primary qHTS for Inhibitors of ATXN expression
AID1347125	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for Rh18 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347107	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID651635	Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347095	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347115	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for NB-EBc1 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347128	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for OHS-50 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347093	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347113	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for LAN-5 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347112	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for BT-12 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347111	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-MC cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347108	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347129	qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Confirmatory screen for SK-N-SH cells	2018	Oncotarget, Jan-12, Volume: 9, Issue:4	Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID588459	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588459	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588459	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, Validation compound set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588461	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588461	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588461	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, Validation compound set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588460	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588460	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588460	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, Validation Compound Set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504810	Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign	2010	Endocrinology, Jul, Volume: 151, Issue:7	A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504812	Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign	2010	Endocrinology, Jul, Volume: 151, Issue:7	A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID504749	qHTS profiling for inhibitors of Plasmodium falciparum proliferation	2011	Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043	Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID588497	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588499	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set	2010	Current protocols in cytometry, Oct, Volume: Chapter 13	Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set	2006	Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5	Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499	High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set	2010	Assay and drug development technologies, Feb, Volume: 8, Issue:1	High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1346986	P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1346987	P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen	2019	Molecular pharmacology, 11, Volume: 96, Issue:5	A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1224864	HCS microscopy assay (F508del-CFTR)	2016	PloS one, , Volume: 11, Issue:10	Increasing the Endoplasmic Reticulum Pool of the F508del Allele of the Cystic Fibrosis Transmembrane Conductance Regulator Leads to Greater Folding Correction by Small Molecule Therapeutics.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	5 (20.83)	29.6817
2010's	13 (54.17)	24.3611
2020's	6 (25.00)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	0 (0.00%)	5.53%
Reviews	0 (0.00%)	6.00%
Case Studies	0 (0.00%)	4.05%
Observational	0 (0.00%)	0.25%
Other	25 (100.00%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (144)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Single-Blind, Cross-Over, Multicenter Study to Validate the Preference Module of the Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Administered to Adult Subjects With Seasonal Allergic Rhinitis During a Three-week Cr[NCT00346775]	Phase 3	97 participants (Actual)	Interventional	2006-05-01	Completed
Efficacy Of Nebulised Beclometasone Versus Placebo In Preventing Viral Wheezing In Pre-School Children[NCT01265342]	Phase 4	576 participants (Anticipated)	Interventional	2010-10-31	Completed
Evaluation and Treatment of Small Airways in COPD[NCT02526758]	Phase 4	90 participants (Anticipated)	Interventional	2015-04-30	Recruiting
Double Blind, Double Dummy, Cross-over Study to Compare the Bronchodilator Effect of CHF1535 pMDI (Fixed Combination of Beclometasone 50 µg + Formoterol 6 µg) Versus Free Combination of Beclometasone Plus Formoterol pMDI in Asthmatic Children[NCT01584492]	Phase 2	59 participants (Actual)	Interventional	2011-12-31	Completed
Inhaled Extra-fine Hydrofluoalkane-beclomethasone (QVAR) in Premature Infants With Bronchopulmonary Dysplasia (BPD); Prospective, Double Blind, Randomized Placebo-control, Multi-center Study[NCT01373008]	Phase 2	60 participants (Anticipated)	Interventional	2011-06-30	Recruiting
Retrospective, Real-life Evaluation of the Effectiveness, Cost-effectiveness and Direct Healthcare Costs of Qvar Pressurised Metered-dose Inhaler (pMDI) Compared With Beclometasone Dipropionate pMDI and Fluticasone pMDI in the Management of Chronic Obstru[NCT01141452]		815,377 participants (Actual)	Observational	2001-01-31	Completed
Assessment of Oxidative Stress Markers in the Upper and Lower Airways of Atopic Children Treated With Nebulized Beclomethasone[NCT01113489]	Phase 3	32 participants (Anticipated)	Interventional	2010-04-30	Completed
Development and Validation of a Sputum Biomarker mRNA Panel for the Diagnostic Work-up of Asthma 2[NCT01224951]		40 participants (Anticipated)	Interventional	2011-01-31	Active, not recruiting
Retrospective, Real-life Observational Evaluation of the Effectiveness and Cost-effectiveness of Extra-fine Hydrofluoroalkane (HFA) Beclometasone (BDP) Compared With Fluticasone Propionate (FP) in the Management of Asthma in a Representative Population in[NCT01287351]		82,903 participants (Actual)	Observational	2004-01-31	Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing the Effect on Linear Growth of Montelukast With Placebo and Inhaled Beclomethasone in Pediatric Patients (Prepubertal, Tanner Stage I) With Mild Asthma[NCT00395408]	Phase 4	360 participants (Actual)	Interventional	2000-06-30	Completed
Personalized Treatment Algorithms for Difficult-to-treat Asthma: Bench to Community[NCT04179461]	Phase 2	21 participants (Actual)	Interventional	2018-03-16	Completed
Nebulized Beclomethasone Dipropionate Improves Respiratory Lung Function in Preschool Children With Recurrent Wheezing[NCT02381158]	Phase 4	12 participants (Actual)	Interventional	2015-02-28	Completed
Open Label, Prospective Study to Evaluate the Effect of Step-up From Non-extra Fine Inhaled Corticosteroids/Long Acting Beta2 Agonist (ICS/LABA) Dry Powder Inhaler (DPI) to Extra Fine Triple Therapy With CHF5993 DPI on Airway Geometry and Lung Ventilation[NCT04876677]	Phase 3	25 participants (Actual)	Interventional	2021-05-25	Completed
A Randomized, Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of 28 Day Treatment With Fostair® Pressurized Metered-dose Inhaler (pMDI) 200/12 on Biomarkers of Platelet Adhesion in Patients With Idiopathic Pulmonary Fibrosis[NCT02048644]	Phase 2	20 participants (Actual)	Interventional	2014-03-31	Completed
Open-label, Randomized, 3-way Cross-over, Placebo Controlled, Single Dose Clinical Pharmacology Study in COPD Patients After Inhalation of CHF 5993 pMDI Using the Standard Actuator With or Without AeroChamber Plus Flow-Vu VHC Spacer[NCT02119234]	Phase 1	36 participants (Actual)	Interventional	2014-03-31	Completed
Recurrent Wheezing in Infants: Risk Factors and Prevention With Probiotics, a Randomized Clinical Trial, Double-blind, Placebo Controlled.[NCT02113072]	Phase 3	60 participants (Actual)	Interventional	2014-04-30	Completed
A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 3-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF CHF 5259 (GLYCOPYRROLATE) PLUS FOSTER® 100/6 µg (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE PL[NCT02127866]	Phase 2	211 participants (Actual)	Interventional	2014-04-30	Completed
A Multicenter, Randomized, Placebo-Controlled, Double-Blind, 2-Period, Parallel-Group Study to Assess the Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients[NCT00911547]	Phase 3	642 participants (Actual)	Interventional	1995-03-31	Completed
Randomized Trial Assessing the Effectiveness of Beclomethasone and Combination Beclomethasone and Salbutamol as Compared With Placebo in Preschool Aged Children With Wheeze[NCT02319564]	Phase 4	0 participants (Actual)	Interventional	2016-04-30	Withdrawn(stopped due to Study population too narrow - unable to recruit any patients.)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate Hydrofluoroalkane (BDP HFA) Nasal Aerosol in Subjects 12 Years of Age and Older With SAR[NCT01024608]	Phase 3	340 participants (Actual)	Interventional	2009-12-31	Completed
Non-Invasive Measures of Distal Lung Disease in Asthmatics Before and After Therapy Directed at the Proximal vs. Distal Lung[NCT00250341]	Phase 4	34 participants (Anticipated)	Interventional	2005-09-30	Completed
Open Label, Prospective, Exploratory Study to Investigate the Effect of Inhaled CHF5993 pMDI on Central and Peripheral Airway Dimensions in COPD Patients by Functional Respiratory Imaging[NCT03268226]	Phase 3	20 participants (Actual)	Interventional	2017-11-20	Completed
Impact of Fixed TRIple Therapy With Beclometasone/Formoterol/Glycopyrronium DPI (Trimbow® in NEXThaler Device) in Chronic Obstructive PulmoNary Disease in rEal-world Settings: Health-related Quality of Life Patient' eXpectations and characterisTics: the T[NCT05948891]		500 participants (Anticipated)	Observational	2023-07-31	Not yet recruiting
A Phase IV, Open Label, Multicentre, Randomised, 2-way Cross-over Exploratory Clinical Trial Comparing TRIMBOW® pMDI and RELVAR® ELLIPTA® DPI on Lung Stiffness Reduction Assessed Through Area Under the Reactance Curve (AX) in COPD.[NCT04671355]	Phase 4	0 participants (Actual)	Interventional	2021-10-04	Withdrawn(stopped due to Continuing delays due to COVID-19 pandemic)
[NCT00109668]	Phase 3	415 participants	Interventional	2004-07-31	Completed
A Phase II, Multicentre, Double-blind, Randomised, 5-way Crossover Study to Test the Non-inferiority of the Acute Bronchodilator Effect of CHF 1535 200/6 µg NEXThaler Versus CHF 1535 100/6 µg NEXThaler in Partially Controlled and Uncontrolled Adult Asthma[NCT02148120]	Phase 2	60 participants (Actual)	Interventional	2014-04-30	Completed
A Single (Assessor)-Blind, Randomised, Three-period, Cross-over Study to Compare the Safety of Flutiform pMDI, Fluticasone pMDI, and Beclometasone Autohaler in Paediatric Subjects Aged 5 to Less Than 12 Years With Mild Persistent Asthma by Means of Knemom[NCT02063139]	Phase 2	48 participants (Actual)	Interventional	2014-02-28	Completed
A Dose-Ranging Study to Assess the Effect of Inhaled Corticosteroids in Ventilated Preterm Neonates[NCT03503994]		41 participants (Actual)	Interventional	2001-07-27	Completed
A Phase 1/2 Study to Evaluate Escalating Doses of SGX201 [Delayed Release Oral Beclomethasone Dipropionate (BDP)] for Prevention of Signs and Symptoms of Acute Enteritis in Patients With Rectal Cancer Treated With Combined Chemotherapy and Radiation Thera[NCT01073384]	Phase 1/Phase 2	16 participants (Actual)	Interventional	2009-12-31	Completed
Comparison of 3% Normal Saline Nebulization Versus Steroid Nebulization in the Treatment of Bronchiolitis[NCT06139029]	Early Phase 1	60 participants (Actual)	Interventional	2022-11-15	Completed
Effects on Small Airways Obstruction of Two Long-term Treatments With Extrafine Beclomethasone/Formoterol vs Fluticasone/Salmeterol in Asthma[NCT01255579]	Phase 4	10 participants (Actual)	Interventional	2007-07-31	Completed
A Randomized, Open Phase II Study of the Incidence and Safety of Radiation Pneumonia in Patients With Locally Advanced NSCLC Treated With Beclomethasone Propionate Inhaled During Radical Radiotherapy Compared With Conventional Radiotherapy[NCT03886441]	Phase 2	194 participants (Anticipated)	Interventional	2019-04-01	Not yet recruiting
An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asth[NCT03084718]	Phase 2	610 participants (Actual)	Interventional	2017-07-28	Completed
A Retrospective Evaluation of the Effectiveness and Cost-effectiveness of HFA-BDP MDI (Qvar®) Compared With CFC-BDP MDI and FP MDI Used in the Management of Asthma in a Representative UK UK Primary Care Population[NCT01141439]		815,377 participants (Actual)	Observational	2001-01-31	Completed
Phase 4 Cost-effectiveness Study of Beclomethasone Versus Ciclesonide as Controller Medications in Pediatric Asthma in a Hospital in Bogotá[NCT01333800]	Phase 4	94 participants (Actual)	Interventional	2010-07-31	Completed
Retrospective, Real-life Observational Evaluation of the Effectiveness of Mixed Maintenance and Reliever Inhaler Types in Patients in the Management of Asthma in a Representative UK Primary Care Population[NCT01313585]		815,377 participants (Actual)	Observational	1991-01-31	Completed
Study of Two Doses of an Investigational Nasal Aerosol Placebo Nasal Aerosol in Children (Ages 6-11) With Seasonal Allergies[NCT01307319]	Phase 3	715 participants (Actual)	Interventional	2011-03-31	Completed
The Effect of Beclomethasone Nasal Spray on Intraocular Pressure in Ocular Hypertension or Controlled Glaucoma[NCT00775489]		19 participants (Actual)	Interventional	2010-01-31	Completed
A Phase 3 Randomised Double Blind Randomised Parallel Multinational Trial Comparing a Fixed Combination of Beclometasone+Formoterol+Glycopyrrolate to Foster® in Patients With Chronic Obstructive Pulmonary Disease[NCT01917331]	Phase 3	1,368 participants (Actual)	Interventional	2014-03-31	Completed
Safety and Efficacy Evaluation of Two Doses of HFA-Propelled Beclomethasone Dipropionate (QVAR) Versus Placebo by Breath Operated and Metered Dose Inhalers in Mild to Moderate Asthmatic Children[NCT00094016]	Phase 3	440 participants	Interventional	2004-10-31	Completed
Non Interventional Study of Ectoin Allergy Nasal Spray Compared to Beclomethasone Nasal Spray[NCT02133053]		50 participants (Actual)	Observational	2011-05-31	Completed
A Randomized, Double-blind, Positive and Placebo-controlled, Single-dose, Crossover Study of the Effects of CHF5993 pMDI (BDP/FF/GB) at the Proposed Therapeutic and Supratherapeutic Doses, on the Cardiovascular Safety in Healthy Subjects[NCT05830071]	Phase 1	95 participants (Actual)	Interventional	2023-03-29	Completed
An Open Label, Randomized, Three-treatment, Three-period, Crossover, Single Dose Study, to Investigate Drug-drug Interaction and Relative Bioavailability Between the Fixed Dose Combination Azelastine Hydrochloride / Beclomethasone Dipropionate (140/100 μg[NCT04817800]	Phase 1/Phase 2	48 participants (Actual)	Interventional	2021-03-25	Completed
Effect of Extra- Fine Versus Coarse-Particle Inhaled Corticosteroids (ICS) on Ventilation Heterogeneity in Children With Poorly Controlled Asthma[NCT02577497]	Phase 4	31 participants (Actual)	Interventional	2016-06-30	Completed
[NCT01016223]	Phase 1	20 participants (Anticipated)	Interventional	2010-03-31	Completed
Safety and Efficacy of SCH 32088 vs Beclomethasone Dipropionate (Vancenase AQ) and Placebo in Seasonal Allergic Rhinitis[NCT03855189]	Phase 3	345 participants (Actual)	Interventional	1993-08-23	Completed
Drug Interaction Study Between Inhaled Beclomethasone and Protease Inhibitors in Healthy Volunteers[NCT00936793]	Phase 1	53 participants (Actual)	Interventional	2009-07-06	Completed
Multicentre, Randomized, Double-blind, Placebo-controlled, Two-arm Parallel Groups Study Design to Demonstrate the Efficacy and Tolerability of a Single Dose of BDP Suspension for Nebulisation 1600 µg vs Placebo in the Treatment of Children Aged 6 Months [NCT00938353]	Phase 3	6 participants (Actual)	Interventional	2010-04-30	Terminated(stopped due to possibility to discriminate the active drug from placebo)
Does Beclomethasone Instillation Above the Cuff of Endotracheal Tubes Decrease the Occurrence of Postoperative Sore Throat? A Randomized Controlled Trial[NCT02687100]	Phase 4	0 participants (Actual)	Interventional	2016-10-31	Withdrawn(stopped due to Due to instillation site of the cortisone and the development of the related SARS-Cov2 infection, it was preferred to terminate the trial and develop it again without beclomethasone)
Effectiveness of Inhaled Corticosteroids in Preschool Children Following Hospital Admission for Acute Dyspnea and Wheeze[NCT00962299]	Phase 4	7 participants (Actual)	Interventional	2010-05-31	Terminated(stopped due to recruitment was unsuccesfull, only 7 patient have been included untill 2012)
Directed Topical Drug Delivery for Treatment for PASC Hyposmia[NCT05970731]	Phase 2	20 participants (Anticipated)	Interventional	2023-09-05	Recruiting
Beclomethasone in Healthy Athletes, Detection in Blood and Urine, and the Effect on Aerobic Performance[NCT05352191]	Phase 4	30 participants (Anticipated)	Interventional	2022-09-01	Not yet recruiting
Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multi-Center, Dose-Range-Finding Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol in Adult and Adolescent Patients (12 Years and Older) With Seasonal Allergic Rhinitis (SAR)[NCT00854360]	Phase 2	487 participants (Actual)	Interventional	2009-03-31	Completed
Effect of Inhaled Steroids on Gene Expression in the Lungs of Healthy Smokers[NCT00826748]	Phase 4	24 participants (Actual)	Interventional	2010-11-30	Terminated(stopped due to Funding)
A Comparison of Beclomethasone Aqueous Spray and Aerosol Delivery Systems in Nasal Polyps[NCT00788463]	Phase 2	30 participants (Actual)	Interventional	2006-11-23	Completed
A 24-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclometasone/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Moderate to Severe Persistent Asthma[NCT00476268]	Phase 3	824 participants (Actual)	Interventional	2004-02-29	Completed
Phase 4 Study of Once-Daily Inhaled Glucocorticosteroid Administration in Asthma Patients[NCT00559689]		24 participants (Actual)	Observational	2005-11-30	Completed
A Phase III, 12-week, Multicentre, Multinational, Randomised, Double-blind, Double-dummy, 3 Arm-parallel Group Study to Test the Efficacy of CHF 1535 (Fixed Combination of Beclomethasone Dipropionate (BDP) Plus Formoterol Fumarate (FF)) Versus a Free Comb[NCT01475032]	Phase 3	638 participants (Actual)	Interventional	2011-09-30	Completed
HFA Beclomethasone in Asthma, a General Practice Research Database Study: Real-life Observational Evaluation of Extra-fine With Standard Particle Size Beclometasone Dipropionate Using the Propellant Hydrofluoroalkane 134a for the Management of Asthma in a[NCT01400217]		56,985 participants (Actual)	Observational	1991-01-31	Completed
48-week,Multinational,Randomized,Double-blind,2-parallel Groups,Comparing the Efficacy of Foster for Maintenance and Reliever Versus Fixed-dose Foster for Maintenance Plus Salbutamol as Reliever in Asthmatics >=18 Years of Age[NCT00861926]	Phase 3	2,079 participants (Actual)	Interventional	2009-03-31	Completed
Dose-Ranging Study of Mometasone Furoate Nasal Spray (SCH 32088) in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (Protocol C95-161)[NCT03879772]	Phase 3	679 participants (Actual)	Interventional	1996-03-12	Completed
Open-label, Non-randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability of a Single Dose of CHF 5993 pMDI in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control Subjects[NCT02040597]	Phase 1	42 participants (Actual)	Interventional	2014-01-31	Completed
[NCT00000576]	Phase 3	0 participants	Interventional	1993-06-30	Completed
Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE)[NCT00200967]	Phase 3	87 participants (Actual)	Interventional	2004-12-31	Completed
Comparative Effectiveness of Extrafine Hydrofluoroalkane Beclometasone Versus Fluticasone in Paediatric Patients - a Retrospective, Real-life Observational Study in a uk Primary Care Asthma Population[NCT01877954]		2,654 participants (Actual)	Observational	2011-02-28	Completed
The Value of FeNO, Blood Eosinophils and TIgE in Predicting the Response to Corticosteroid in Patients With Chronic Cough[NCT05888350]		520 participants (Anticipated)	Interventional	2023-07-30	Not yet recruiting
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP HFA Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA) Axis When Administered in Adolescent and Adult Subjects (12 t[NCT01133626]	Phase 3	107 participants (Actual)	Interventional	2010-06-30	Completed
The Effect of HFA-beclomethasone Dipropionate on Static Lung Volumes in COPD[NCT00238082]		20 participants (Actual)	Interventional	1999-11-30	Terminated
Use of Pathological Phenotype to Determine Optimal Management for Moderate to Severe Preschool Wheeze[NCT02517099]	Phase 2	60 participants (Actual)	Interventional	2015-06-05	Completed
A 12-week Phase III Study to Evaluate the Efficacy and Tolerability of Beclomethasone Dipropionate/Formoterol Single Inhaler HFA 134a-pMDI in Adult Patients With Mild to Moderate Persistent Asthma[NCT00862264]	Phase 3	286 participants (Actual)	Interventional	2004-08-31	Completed
Explorative Study of the Safety/Tolerability of Beclomethasone Dipropionate Suppositories: Evaluation of Systemic Bioavailability and Effects on 24-Hour Plasma Cortisol Profile of 6 mg Delivered Once Daily Versus 3 mg Delivered Twice Daily in Healthy Adul[NCT04873063]	Phase 1	28 participants (Actual)	Interventional	2021-10-22	Completed
Nebulized Beclometasone Dipropionate Improves Nasal Patency in Children With Allergic Rhinitis[NCT02646904]	Phase 4	68 participants (Actual)	Interventional	2016-05-31	Completed
A Single-dose, Open-label, Randomized, 2-way Cross-over Study of CHF 1535 35/4 NEXThaler® (Fixed Combination of Beclometasone Dipropionate (BDP) 35 μg Plus Formoterol Fumarate (FF) 4 μg Versus the Free Combination of Licensed BDP DPI (Dry Powder Inhaler) [NCT02787967]	Phase 2	26 participants (Actual)	Interventional	2016-08-31	Completed
A Single-dose, Open-Label, 2-Way Cross-Over, Clinical Pharmacology Study Of Chf 1535 50/6 HFA pMDI (Fixed Combination Of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6 µg) Using The Aerochamber Plus™ Spacer Device Versus The Free Combination [NCT01848769]	Phase 2	20 participants (Actual)	Interventional	2009-09-30	Completed
"A 48-week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-arm Parallel Group Clinical Study of Fixed Combination Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus Fixed Combin[NCT00476099]	Phase 3	828 participants (Actual)	Interventional	2006-12-31	Completed
Retrospective, Real-life Observational, Matched Cohort Evaluation of the Effectiveness of BDP/FOR (Fostair® 100/6) and FP/SAL (Seretide® 125) in Patients Switching From Seretide to Fostair in UK Primary Care Asthma Management[NCT01242098]		137 participants (Actual)	Observational	2008-01-31	Completed
Effect of Inhaled Steroids in Combination With a Long Acting Bronchodilator on Gene Expression in the Lungs of Healthy Smokers[NCT00532584]	Phase 4	0 participants (Actual)	Interventional	2011-02-28	Withdrawn(stopped due to Study not initiated due to funding.)
Obesity, Inflammation and Response to Therapy in Asthma - Ancillary to Asthma Clinical Research Network (ACRN) Trials[NCT00557180]		33 participants (Actual)	Observational	2007-10-31	Completed
A Prospective Non-interventional Study in Patients With Chronic Obstructive Pulmonary Disease That Evolve to Fixed Long-acting Muscarinic Antagonist/Long-acting beta2-agonist/Inhaled Corticosteroid Triple Therapy, Trimbow®[NCT03627858]		149 participants (Actual)	Observational	2018-08-01	Completed
Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial[NCT03846570]	Phase 3	34 participants (Actual)	Interventional	2019-01-29	Terminated(stopped due to Insufficient inclusion rate (due to COVID-19 pandemic))
A Randomized, Parallel Group, Placebo-controlled, Multicenter Phase 3 Study With a PK Sub-group Study With Beclomethasone HFA at 400 μg and 800 μg Daily Doses Compared to Placebo and QVAR in Persistent Asthma.[NCT03834012]	Phase 3	0 participants (Actual)	Interventional	2019-02-28	Withdrawn(stopped due to Sponsor Decision)
A Randomized, Placebo-Controlled, Multi-Center Study of Oral Beclomethasone Dipropionate With Ten Days of Prednisone for Treatment of Gastrointestinal Graft Vs. Host Disease[NCT00233896]	Phase 3	130 participants	Interventional	2001-07-31	Completed
Evaluation of Effects of Chronic Dose Exposure to Cardioselective and Non-cardioselective Beta Blockers on Measures of Cardiopulmonary Function in Moderate to Severe COPD.[NCT01656005]	Phase 4	18 participants (Actual)	Interventional	2012-08-31	Completed
A Clinical Study to Investigate the Effect of Rosiglitazone, Theophylline and Inhaled Corticosteroid, Inflammation and Pulmonary Function in Asthmatic Smokers[NCT00119496]	Phase 2/Phase 3	79 participants (Actual)	Interventional	2005-07-31	Completed
The Anti-Inflammatory Effect of Extrafine HFA-Beclometasone Versus HFA-Fluticasone, by Means of Exhaled Nitric Oxide, Inflammatory Markers in Exhaled Breath Condensate and Conventional Parameters[NCT00402207]		33 participants	Interventional	2005-08-31	Completed
A Phase II Multi-Center, Randomized, Double-Blind, Active and Placebo-Controlled 7 Day Study of Mast Cell Inhibitor, R926112, in Patients With Symptomatic Seasonal Allergic Rhinitis[NCT00115089]	Phase 2	375 participants	Interventional	2005-07-31	Completed
Asthma Clinical Research Network (ACRN) Trial - Tiotropium Bromide as an Alternative to Increased Inhaled Corticosteroid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (TALC)[NCT00565266]	Phase 3	210 participants (Actual)	Interventional	2008-05-31	Completed
A Randomized, Cross Over Study Evaluating the Effect of Flovent Discus 100 mcg BID vs QVAR 80 mcg BID vs Pulmicort Flexhaler 180 mcg BID on Short Term Growth in Pediatric Subjects With Asthma[NCT01520688]	Phase 4	32 participants (Actual)	Interventional	2012-02-29	Completed
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate)in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gastroin[NCT00926575]	Phase 3	140 participants (Actual)	Interventional	2009-10-31	Terminated(stopped due to An independent Data Safety Monitoring Board recommended the study be stopped due to futility)
Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Efficacy and Safety of BDP HFA Nasal Aerosol (320 Mcg, Once Daily) in the Treatment of Perennial Allergic Rhinitis (PAR) in Adult and Adolescent Subjects (1[NCT01134705]	Phase 3	474 participants (Actual)	Interventional	2010-05-31	Completed
Double Blind, Multinational, Multicentre, Parallel-group, Placebo-controlled Design Trial of the Efficacy and Safety of Nebulised Beclometahsone Dipropionate (400 μg b.i.d.) Plus as Needed Salbutamol Versus as Needed Salbutamol or as Needed Salbutamol/Bec[NCT00497523]	Phase 3	283 participants (Actual)	Interventional	2006-03-31	Completed
Prospective, Randomised, Open-label, Multicentre, Active Drug Controlled, Parallel Group Design Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate 400 mcg + Formoterol 24 mcg pMDI Via HFA-134a (Foster™) vs. Fluticasone Propionate 500[NCT00497237]	Phase 3	382 participants (Anticipated)	Interventional	2007-04-30	Completed
Isolation and Comparative Efficacy of the Combination of beclometasona0, 025% + Gentamicin 0.1% + Clotrimazole 1% Topical Dermatological Cream of GLENMARK PHARMACEUTICALS, in Patients Infected With Acne[NCT01244256]	Phase 2/Phase 3	80 participants (Anticipated)	Interventional	2007-04-30	Suspended
[NCT00000578]	Phase 3	0 participants	Interventional	1994-04-30	Completed
Evaluation of Any Steroid Sparing Effect of Beta Blocker Therapy on Airway Hyper-responsiveness in Stable, Mild to Moderate Asthmatics[NCT01544634]	Phase 2	16 participants (Actual)	Interventional	2012-04-04	Completed
Management of HIV-Infected Patients at Risk of Recurrent Purulent Sinusitis: Role of Anti-Inflammatory, Antibacterial, and Decongestant Prophylaxis[NCT00000752]	Phase 2	0 participants (Actual)	Interventional		Withdrawn
A Phase III, Randomized, Placebo-Controlled, Multicenter Study of the Safety, Efficacy, and Pharmacokinetics of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction With Ten Days of High-Dose Prednisone Therapy in the Treatment of Patients With Gr[NCT00043147]	Phase 3	0 participants	Interventional	2002-04-30	Completed
Compassionate Use Of Oral Beclomethasone Dipropionate For Treatment Of Gastrointestinal Graft Versus Host Disease[NCT00055666]		51 participants (Actual)	Interventional	2001-03-31	Completed
Oral Beclomethasone Dipropionate Capsules for Treatment of Intestinal Graft-Versus-Host Disease: Compassionate Use in Patients With Contraindictions to High-Dose Immunosuppressive Therapy[NCT00010283]	Phase 1/Phase 2	0 participants	Interventional	2000-07-31	Completed
DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, PARALLEL-GROUP DESIGN CLINICAL TRIAL OF THE EFFICACY AND TOLERABILITY OF CHF 1535 (BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg) pMDI VIA HFA-134a vs. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI (SERETIDE®)[NCT00394368]	Phase 3	180 participants	Interventional	2004-11-30	Completed
A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrro[NCT04320342]	Phase 3	2,934 participants (Anticipated)	Interventional	2022-04-28	Recruiting
A Single Centre, Randomised, Double-blind, Double-dummy, 2-way Cross Over Study to Compare Safety Assessed by Knemometry and Urinary Cortisol Measurements of CHF1535 50/6 Pmdi (Fixed Combination of Beclomethasone Dipropionate and Formoterol Fumarate) and [NCT01450774]	Phase 3	72 participants (Actual)	Interventional	2011-09-30	Completed
Double Blind, Double Dummy, Multinational, Multicentre, Parallel-Group Design Clinical Trial of the Efficacy and Tolerability of CHF 1535 (Beclomethasone Dipropionate 100 µg + Formoterol 6 µg) pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dr[NCT00413387]	Phase 3	219 participants (Actual)	Interventional	2004-09-30	Completed
The Effect of HFA - Beclomethasone Dipropionate - Qvar - on Bronchial Hyperreactivity in Preschool Children[NCT01006655]	Phase 2	21 participants (Actual)	Interventional	2009-03-31	Completed
Investigation of the Real World Effectiveness of Beclomethasone Dipropionate (BDP) Nasal Aerosol in Perennial Allergic Rhinitis (PAR) Patients[NCT01632540]		824 participants (Actual)	Observational [Patient Registry]	2012-07-31	Completed
Childhood Asthma Research and Education (CARE) Network Trial - Treating Children to Prevent Exacerbations of Asthma (TREXA)[NCT00394329]	Phase 3	288 participants (Actual)	Interventional	2006-11-30	Completed
OPEN-LABEL, PROSPECTIVE EXPLORATORY STUDY TO ASSESS THE EFFECTS OF FORMOTEROL AND BECLOMETASONE DIPROPIONATE COMBINATION THERAPY USING A DPI DEVICE ON CENTRAL AND PERIPHERAL AIRWAY DIMENSIONS IN ASTHMATIC PATIENTS.[NCT01650441]	Phase 2	31 participants (Actual)	Interventional	2012-04-30	Completed
A SINGLE CENTRE, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, 2-WAY CROSS OVER STUDY TO COMPARE SAFETY ASSESSED BY KNEMOMETRY AND URINARY CORTISOL MEASUREMENTS OF CHF1535 50/6 NEXThaler® (FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE AND FORMOTEROL FUMARATE[NCT01658891]	Phase 3	0 participants (Actual)	Interventional	2014-02-28	Withdrawn
Multicentre, Randomized, Double-blind, Parallel Group, Placebo-Controlled Study on the Therapeutic Efficacy and Safety of Beclomethasone Dipropionate Suspension for Inhalation 800 µg Twice Daily vs. Placebo Added to Antibiotic Therapy in Patients With Acu[NCT01691677]	Phase 3	166 participants (Actual)	Interventional	2013-01-31	Completed
A Retrospective Evaluation of Effectiveness and Cost-effectiveness of Extrafine HFA-BDP Compared With Combination ICS/LABA Therapy in the Management of Asthma in a Representative Population of UK Primary Care Patients[NCT01697722]		815,377 participants (Actual)	Observational	1991-01-31	Completed
Asthma Symptom Based Adjustment of Inhaled Steroid Therapy in African American Children[NCT02298205]	Phase 4	206 participants (Actual)	Interventional	2015-02-28	Completed
Effects Of Extra-fine Particle HFA-becLomethasone (HFA-QVAR) Versus Course Particle Treatment In Smokers and Ex-smokers With Asthma[NCT01741285]	Phase 4	40 participants (Actual)	Interventional	2013-04-30	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week, Clinical Study Designed to Assess the Efficacy and Safety of BDP Nasal Aerosol (80 mcg, Once Daily) in Pediatric Subjects (4 to 11 Years of Age) With PAR[NCT01783548]	Phase 3	547 participants (Actual)	Interventional	2013-01-31	Completed
Open Label, Uncontrolled, Non-randomized, Single Dose, Scintigraphic Study to Investigate Lung Deposition of Inhaled 99mTc Radiolabelled CHF5993 pMDI in Healthy Volunteers, Asthmatic and COPD Patients[NCT02975843]	Phase 1	28 participants (Actual)	Interventional	2016-11-21	Completed
Randomized Double-blind Placebo-controlled Crossover Study to Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function in COPD Patients.[NCT01466712]	Phase 4	20 participants (Anticipated)	Interventional	2011-11-30	Enrolling by invitation
A Single-dose,Open-label,Randomized,2-way Cross-over,Clinical Pharmacology Study of CHF1535 50/6 NEXT DPI® Fixed Combination of Beclomethasone Dipropionate 50µg Plus Formoterol Fumarate 6µg)Versus the Free Combination of Licensed Beclomethasone DPI and Fo[NCT01468272]	Phase 2	26 participants (Actual)	Interventional	2011-11-30	Completed
Non-inferiority Evaluation of Trimbow in Critically Ill Patients Admitted in ICU Compared to Standard of Care[NCT04737655]	Phase 4	200 participants (Anticipated)	Interventional	2021-02-15	Not yet recruiting
Study of Asthma Phenotypes and Pharmacogenomic Interactions by Race-Ethnicity (SAPPHIRE)[NCT01142947]		362 participants (Actual)	Interventional	2007-10-31	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Clinical Study to Assess the Long-term Efficacy and Safety of BDP HFA Nasal Aerosol (320 mcg, Once Daily) in Adult and Adolescent Subjects (12 Years of Age and Older) With Perennial A[NCT00988247]	Phase 3	529 participants (Actual)	Interventional	2009-10-31	Completed
A Randomized, Parallel Group, Multicenter, Double -Blind, Double-dummy, Placebo-controlled Phase 3 Study With Beclomethasone Dipropionate HFA at 100 μg, 200 μg and 400 μg Daily Doses Compared to Placebo in Mild or Moderate Persistent Asthma[NCT03835871]	Phase 3	0 participants (Actual)	Interventional	2019-02-28	Withdrawn(stopped due to Sponsor decision)
Multinational, Double Blind, Randomised, Parallel Group Study on the Therapeutic Efficacy and Safety of Beclomethasone Dipropionate 250 mg Combined With Salbutamol 100 mg in the Treatment of Patients With Mild Persistent Asthma.[NCT00382889]	Phase 3	480 participants	Interventional	2002-08-31	Completed
Open Label, Uncontrolled, Non-randomized, Single Dose, Scintigraphic Study to Investigate Lung Deposition of Inhaled 99mTc Radiolabelled TRIMBOW® pMDI in Healthy Volunteers, Asthmatic and COPD Patients[NCT03795350]	Phase 1	19 participants (Actual)	Interventional	2019-01-14	Terminated(stopped due to In light of the cessation of non-essential clinical activities at CPU due to the COVID-19 pandemic, the sponsor has determined to terminate the study early.)
A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 80 or 160 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler [NCT02040766]	Phase 3	628 participants (Actual)	Interventional	2013-12-31	Completed
A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of 320 or 640 mcg/Day of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler[NCT02031640]	Phase 3	1,113 participants (Actual)	Interventional	2013-12-31	Completed
Extra-fine Formoterol/Beclomethasone in the Treatment of Asthmatic Crisis[NCT02345993]	Phase 4	120 participants (Anticipated)	Interventional	2015-01-31	Active, not recruiting
A Single Dose, Randomized, Open-label, 3-Way Cross-over Clinical Pharmacology Study, to Evaluate the Systemic Exposure of BDP, Beclomethasone 17-monoproprionate, Formoterol Fumarate, and Glycopyrronium Bromide, After Inhalation of the Fixed Combination BD[NCT05898984]	Phase 1	69 participants (Anticipated)	Interventional	2023-04-24	Recruiting
A Study Evaluating the Effect of Omnaris Nasal Spray 200 mcg QD & Alvesco Inhalation Aerosol 80 BID vs Beconase AQ Nasal Spray 168 mcg BID & QVAR Inhalation Aerosol 40 mcg BID vs Placebo Nasal Spray QD & Placebo Inhalation Aerosol BID on Short Term Growth[NCT01550471]	Phase 4	22 participants (Actual)	Interventional	2012-03-31	Completed
Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma[NCT03141424]	Phase 4	110 participants (Anticipated)	Interventional	2022-06-01	Recruiting
Targeted Small Airways Therapy in Persistent Asthma[NCT01894048]	Phase 4	26 participants (Actual)	Interventional	2013-10-28	Completed
The Effect of Beclomethasone/Formoterol in Extra-fine Formulation on Quality of Life and Dyspnea is Associated to the Improvement in Small Airway Dysfunction in COPD Patients. A Pilot Study (IOSCOPD20161102)[NCT04421742]		43 participants (Actual)	Observational	2017-05-31	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Clinical Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) at 320 or 640 mcg/Day in Adolescent and Adult Patients 12 Ye[NCT02513160]	Phase 3	713 participants (Actual)	Interventional	2015-09-30	Completed
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Clinical Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Adolescent and Adult Patients 12 Ye[NCT02040779]	Phase 3	273 participants (Actual)	Interventional	2013-12-26	Completed
Randomized Clinical Trials to Compare Asthma Control Efficacy of the Fine-particle Combination Formoterol/Beclomethasone by pMDI Administered With and Without Spacer.[NCT01453881]	Phase 3	45 participants (Actual)	Interventional	2011-04-30	Completed
A Phase II Study to Evaluate the Efficacy of Oral Beclomethasone Dipropionate for Prevention of Acute GVHD After Hematopoietic Cell Transplantation With Myeloablative Conditioning Regimens[NCT00489203]	Phase 2	140 participants (Actual)	Interventional	2007-04-30	Completed
The Evaluation of FeNO for Predicting Response to an Inhaled Corticosteroid in Subjects With Non-specific Respiratory Symptoms[NCT02294279]	Phase 4	360 participants (Actual)	Interventional	2014-05-31	Completed
Randomized, Open-label, Three Arms Study to Evaluate the Efficacy of Inhaled Therapies in the Treatment of Acute Symptoms Associated With COVID-19 and in the Prevention of the Use of Health Resources in Patients With ≥ 18 Years Old (TRIVID Study)[NCT04937543]	Phase 2	50 participants (Actual)	Interventional	2021-06-28	Active, not recruiting
A Randomized, Open-Label, 3-Period Crossover, Single-Dose Clinical Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Beclomethasone Dipropionate (160 and 320 mcg) Delivered Via Breath-Actuated Inhaler (BAI) and Metered-Dose Inhaler (M[NCT02030457]	Phase 1	72 participants (Actual)	Interventional	2013-12-31	Completed
Supplementation of Extra Virgin Olive Oil Monocultivar Coratina in Patients With Active Ulcerative Colitis[NCT03408847]		30 participants (Anticipated)	Interventional	2017-11-20	Recruiting
Initiating Inhaled Corticosteroid Therapy at Discharge From the Pediatric Emergency Department to Prevent Asthma Relapse: A Randomized Control Trial[NCT03369847]	Phase 4	43 participants (Actual)	Interventional	2017-09-10	Completed
A 12-Week, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone/Salmeterol Multidose Dry Powder Inhaler in Adolescent and Adult Patients With Persistent Asthma Symptom[NCT02139644]	Phase 3	787 participants (Actual)	Interventional	2014-06-30	Completed
A Randomized Placebo Controlled Trial of Inhaled Beclomethasone After Community-acquired Respiratory Viral Infection in Lung Transplant Recipients[NCT02351180]	Phase 1/Phase 2	16 participants (Actual)	Interventional	2017-02-01	Completed
A 12 Week, Randomized, Double-blind, Multicenter, Active Controlled, 2-Arm Parallel Group Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose (Fixed Combination of Extrafine Beclomethasone Dipropionate Plus Formoterol Fumarate) Compar[NCT05292586]	Phase 3	580 participants (Anticipated)	Interventional	2022-10-05	Recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Efficacy of orBec® (Oral Beclomethasone 17,21-Dipropionate) Administered as Monotherapy in the Treatment of Upper Gastrointestinal (GI) Symptoms Caused by GVHD in[NCT01925950]	Phase 2	2 participants (Actual)	Interventional	2013-12-31	Terminated(stopped due to The study was stopped due to patient enrollment challenges.)
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 6-Week Study Designed to Investigate the Effects of BDP Nasal Aerosol on the Hypothalamic-Pituitary-Adrenal (HPA)-Axis in Pediatric Subjects (6 to 11 Years of Age) With Perennial Allergic Rhi[NCT01697956]	Phase 3	99 participants (Actual)	Interventional	2012-10-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Mean rTNSS Over Period

The rTNSS score is the sum of the four individual symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is scored on a 4 point scale ranging from 0 to 3. Each individual symptom was evaluated using a scale of 0 (none; symptom is not present), 1 (mild; sign/symptom clearly present but minimal awareness; easily tolerated), 2 (moderate; definite awareness of sign/symptom that is bothersome but tolerable), or 3 (severe; sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The rTNSS ranges from 0 (none) to 12 (severe). Higher score represents greater severity of symptoms. The reflective assessment of the TNSS scores the four nasal symptoms over the previous 12 hours and are assessed in the morning and evening. The participants themselves scored nasal symptoms in a diary card. The analysis was done based on the rTNSS averaged over the two weeks of the treatment period. (NCT00346775)
Timeframe: Day 1 to 8 of each treatment period

Intervention	Score on scale (Least Squares Mean)
Beconase	5.3
Nasarel	5.1

Correlation of EARNS-Q Preference Module With EARNS-Q Experience Module Change Scores

The 28 items of the EARNS-Q experience module assess 14 attributes with regard to their product rating and their importance of efficacy, SP, DC and SD. The EARNS-Q preference module consists of additional 15 items that evaluate preference by comparing two products based on the same 14 experience attributes as well as on OPP. Change in EARNS-Q Experience Module domain scores was calculated as scores in TP2 minus scores in TP1. If the change in EARNS-Q Experience Module domain scores is +ve, product in TP2 is preferred and vice-versa. A higher product rating for one of the sprays lead to a preference for that spray. The EARNS-Q preference module was assessed only once, at the end of TP2. Positive correlations indicate agreement (i.e. preference for a product is positively associated with better experience with same product). (NCT00346775)
Timeframe: Day 1 to Day 23

Intervention	correlation coefficient (Number)
	Preference Total-Experience Total	Preference Total-Experience Efficacy	Preference Total-Experience SP	Preference Total-Experience DC	Preference Total- Experience SD	Preference Efficacy- Experience Total	Preference Efficacy- Experience Efficacy	Preference Efficacy- Experience SP	Preference Efficacy- Experience DC	Preference Efficacy- Experience SD	Preference SP- Experience Total	Preference SP - Experience Efficacy	Preference SP - Experience SP	Preference SP - Experience DC	Preference SP - Experience SD	Preference DC- Experience Total	Preference DC - Experience Efficacy	Preference DC - Experience SP	Preference DC - Experience DC	Preference DC- Experience SD	Preference SD- Experience Total	Preference SD - Experience Efficacy	Preference SD - Experience SP	Preference SD - Experience DC	Preference SD- Experience SD	Preference OPP- Experience Total	Preference OPP - Experience Efficacy	Preference OPP - Experience SP	Preference OPP - Experience DC	Preference OPP- Experience SD
Beconase + Nasarel	0.72	0.38	0.66	0.42	0.38	0.47	0.55	0.29	0.20	0.29	0.75	0.25	0.79	0.43	0.29	0.63	0.20	0.59	0.45	0.38	0.47	0.24	0.38	0.32	0.39	0.59	0.44	0.47	0.33	0.35

Correlations of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Preference Module With Treatment Satisfaction Questionnaire for Medicines (TSQM) Change Scores and Change in Mean Daily Reflective Total Nasal Symptom (rTNSS) Scores

EARNS-Q Preference Module consists of efficacy, sensory perception (SP), device characteristic (DC), spray delivery (SD), overall product preference (OPP) and total domain. TSQM consists of global satisfaction (GS), convenience, effectiveness and side-effects (SE) domains. Positive (+ve) correlation of EARNS-Q preference scores with change on TSQM domains indicate that preference for a product is associated with better TSQM scores. Negative (-ve) correlation with mean daily rTNSS indicate that preference for a product is associated with lower mean daily rTNSS. Change in TSQM domain scores and mean daily rTNSS was calculated as scores in Treatment Period (TP) 2 minus scores in TP1; change in TSQM is +ve, product in TP2 is preferred, vice-versa; change in rTNSS is -ve, product administered in TP2 is preferred, vice-versa. (NCT00346775)
Timeframe: Day 1 to Day 23

Intervention	correlation coefficient (Number)
	EARNS-Q Total-TSQM GS	EARNS-Q Total-TSQM Convenience	EARNS-Q Total-TSQM Effectiveness	EARNS-Q Total-TSQM SE	EARNS-Q Total-Mean rTNSS	EARNS-Q Efficacy-TSQM GS	EARNS-Q Efficacy -TSQM Convenience	EARNS-Q Efficacy-TSQM Effectiveness	EARNS-Q Efficacy -TSQM SE	EARNS-Q Efficacy-Mean rTNSS	EARNS-Q SP-TSQM GS	EARNS-Q SP-TSQM Convenience	EARNS-Q SP-TSQM Effectiveness	EARNS-Q SP-TSQM SE	EARNS-Q SP-Mean rTNSS	EARNS-Q DC-TSQM GS	EARNS-Q DC-TSQM Convenience	EARNS-Q DC-TSQM Effectiveness	EARNS-Q DC-TSQM SE	EARNS-Q DC-Mean rTNSS	EARNS-Q SD-TSQM GS	EARNS-Q SD-TSQM Convenience	EARNS-Q SD-TSQM Effectiveness	EARNS-Q SD-TSQM SE	EARNS-Q SD-Mean rTNSS	EARNS-Q OPP-TSQM GS	EARNS-Q OPP-TSQM Convenience	EARNS-Q OPP-TSQM Effectiveness	EARNS-Q OPP-TSQM SE	EARNS-Q OPP-Mean rTNSS
Beconase + Nasarel	0.45	0.45	0.44	0.36	-0.39	0.56	0.30	0.59	0.26	-0.53	0.33	0.38	0.33	0.37	-0.27	0.29	0.49	0.24	0.26	-0.21	0.34	0.37	0.30	0.25	-0.27	0.54	0.35	0.52	0.30	-0.50

Adherence of Asthma Controller Medication

Adherence was measured using the Propeller Health Inhaler monitor and web-based software management platform that tracks adherence of asthma medications. The change in adherence was calculated between V1 (baseline) to V3 (12 Months). (NCT04179461)
Timeframe: Baseline to 12 months

Intervention	percentage of medication taken (Median)
	V1	V3
Personalized Treatment	42	36

Asthma Control Test (ACT)

"ACT was measured by questionnaire, assessing frequency of reported asthma symptoms, rescue medication use, the effect of asthma on daily functioning, and overall asthma control. The change in ACT score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).~[The ACT score has a minimum value = 5, maximum value = 25, a score 19 indicates well-controlled asthma]" (NCT04179461)
Timeframe: Baseline to 12 months

Intervention	score on a scale (Median)
	V1	V2	V3
Personalized Treatment	23.0	21.7	22.5

Change in Composite Asthma Severity Index (CASI)

"CASI was measured by questionnaire and is a severity score of symptom burden, exacerbations, healthcare utilization, lung function and dose of inhaled corticosteroids. The change in CASI score was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months).~[The CASI score has a minimum value = 0, maximum value = 20, a higher score indicates greater asthma severity]" (NCT04179461)
Timeframe: Baseline to 12 months

Intervention	score on a scale (Median)
	V1	V2	V3
Personalized Treatment	5	5	5

Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC)

"FEV1 is air volume exhaled in 1 second during spirometry. Forced vital capacity is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. The change in FEV1/FVC was calculated between V1 (Baseline), V2 (Guideline Care - before intervention), and V3 (12 Months). This will be used as a measurement in asthma severity.~[A lower FEV1/FVC ratio indicates more severe asthma]" (NCT04179461)
Timeframe: Baseline to 12 months

Intervention	Ratio (Median)
	V1	V2	V3
Personalized Treatment	0.81	0.8	0.8

Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma

"The daily daytime symptom score was determined by averaging the daily scores (the patient scored his/her symptoms [from 0 (best) to 6 (worst)] on a daily basis.) for the four questions on the Daytime Asthma Symptoms Diary.~The average daytime symptom score for the visit was determined by averaging the daily symptom scores over all days between two consecutive visits." (NCT00911547)
Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Intervention	Units on a Scale (Least Squares Mean)
Placebo	0.31
Montelukast	0.27
Beclomethasone	-0.02
Montelukast+ Beclomethasone	-0.13

Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma

Morning PEFR was measured in triplicate immediately upon arising before taking any medication and the best value recorded on the overnight asthma symptoms diary. The mean morning PEFR for the visit was determined by averaging all valid PEFR measurements for the days between consecutive visits. (NCT00911547)
Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Intervention	Liters/minute (Least Squares Mean)
Placebo	-27.10
Montelukast	-15.37
Beclomethasone	2.65
Montelukast+ Beclomethasone	10.41

Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only

"Mean change from baseline in Nocturnal asthma score; the patient scored his/her symptoms [from 0 (best) to 3 (worst)] on a daily basis. Responses to the question, Did you wake up with asthma symptoms? (no, once, more than once, awake all night), were assigned numerical values (0, 1, 2, 3, respectively).~The average score for the visit was determined by averaging the daily scores over all days between consecutive visits." (NCT00911547)
Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Intervention	Units on a Scale (Least Squares Mean)
Placebo	0.17
Montelukast	0.18
Beclomethasone	-0.06
Montelukast+ Beclomethasone	-0.20

Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma

Mean percent change from baseline in FEV1 in patients with chronic asthma averaged over 16 weeks for the Beclo and MK+ Beclo groups and averaged over last 10 weeks for the Placebo and MK groups (NCT00911547)
Timeframe: Baseline & over 16 weeks for the Beclomethasone (Beclo) and Montelukast (MK) + Beclo groups and over last 10 weeks for the Placebo and MK groups

Intervention	Percentage of Change (Least Squares Mean)
Placebo	-11.96
Montelukast	-5.31
Beclomethasone	0.72
Montelukast+ Beclomethasone	5.08

Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use

Beta-agonist medication use from the daytime and overnight asthma symptoms diaries for each 24-hour period was added to determine the daily total number of puffs used. The average daily number of puffs for the visit was determined as the average daily number of puffs over all days between consecutive visits. (NCT00911547)
Timeframe: Baseline & over 16 weeks for the Beclo and MK + Beclo groups and over last 10 weeks for the Placebo and MK groups

Intervention	Percent Change (Least Squares Mean)
Placebo	59.20
Montelukast	44.48
Beclomethasone	6.04
Montelukast+ Beclomethasone	-5.51

Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline

The adult RQLQ has 28 questions in 7 domains. Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Not Troubled to 6 = Extremely Troubled) for the domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, and eye symptoms. The domain of 'emotional' utilized a separate scale (0 = None of the time to 6 = All of the time). The overall RQLQ score is the mean of all 28 responses. Week 2 scores were compared to baseline scores. A negative change from baseline score indicates improvement. (NCT01024608)
Timeframe: Day 0 (Baseline), Day 15

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-1.2
Placebo	-0.8

Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period

"Participants recorded the severity of their ocular symptoms (Itching/burning eyes, tearing/watering eyes, and redness of eyes) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities).~The total ocular symptom score ranges from 0 to 9 (worst symptoms). A negative change from baseline score indicates improvement." (NCT01024608)
Timeframe: Baseline (Days -3 to 0), and Days 1-15

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-1.3
Placebo	-0.7

Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period

"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 10 minutes (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The iTNSS (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement." (NCT01024608)
Timeframe: Baseline (Days -3 to 0), and Days 1-15

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-1.7
Placebo	-0.8

Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period

"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, nasal itching and nasal congestion) over the past 12 hours (prior to the assessment) twice daily (AM and PM) using the following scale:~0=absent (no sign/symptom present); 1=mild (sign/symptom present, easily tolerated); 2=moderate (definite awareness of sign/symptom, bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities and/or sleeping).~The rTNSS (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates symptom improvement." (NCT01024608)
Timeframe: Baseline (Days -3 to 0), and Days 1-15

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-2.0
Placebo	-1.0

12-lead ECG Parameters - Heart Rate - Change From Baseline

"12-lead electrocardiogram (12-lead ECG) parameter - heart rate (HR) was measured at baseline (Day 1) and Week 8.~Change from baseline.~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;~bpm=Beats per minute;" (NCT03084718)
Timeframe: Baseline, Week 8

Intervention	bpm (Mean)
Treatment A (CHF 718 pMDI 100 µg TDD)	0.6
Treatment B (CHF 718 pMDI 400 µg TDD)	0.2
Treatment C (CHF 718 pMDI 800 µg TDD)	0.4
Treatment D (Placebo)	1.2
Treatment E (QVAR^®, 320 µg TDD)	-0.4

24-hr Creatinine - Change From Baseline.

"24-hr Creatinine - Change From Baseline.~For the evaluation of the 24-hr creatinine excretion, 24-hour urine sample were collected. Creatinine was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;" (NCT03084718)
Timeframe: Baseline, Week 8

Intervention	umol/mol (Median)
Treatment A (CHF 718 pMDI 100 µg TDD)	0.00
Treatment B (CHF 718 pMDI 400 µg TDD)	0.00
Treatment C (CHF 718 pMDI 800 µg TDD)	0.00
Treatment D (Placebo)	0.00
Treatment E (QVAR^®, 320 µg TDD)	0.00

24-hr Urine Free Cortisol - Change From Baseline

"24-hr Urinary Free Cortisol - Change From Baseline.~For the evaluation of the 24-hr Urine-Free cortisol excretion, 24-hour urine samples were collected. Urine-free cortisol was measured using liquid chromatography-tandem mass spectrometry (LC-MS/MS).~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose;" (NCT03084718)
Timeframe: Baseline, Week 8

Intervention	nmol/day (Median)
Treatment A (CHF 718 pMDI 100 µg TDD)	-3.60
Treatment B (CHF 718 pMDI 400 µg TDD)	-5.35
Treatment C (CHF 718 pMDI 800 µg TDD)	-4.10
Treatment D (Placebo)	1.40
Treatment E (QVAR^®, 320 µg TDD)	-3.50

Pre-dose Morning FEV1 at Week 4 - Change From Baseline

"Change from baseline in pre-dose morning FEV1 at Week 4.~Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Definitions:~Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;" (NCT03084718)
Timeframe: Baseline, Week 4

Intervention	Litres (Least Squares Mean)
Treatment A (CHF 718 pMDI 100 µg TDD)	0.021
Treatment B (CHF 718 pMDI 400 µg TDD)	0.120
Treatment C (CHF 718 pMDI 800 µg TDD)	0.073
Treatment D (Placebo)	0.003
Treatment E (QVAR^®, 320 µg TDD)	0.077

Pre-dose Morning FEV1 at Week 8 - Change From Baseline

"Change from baseline in pre-dose morning FEV1 (average of pre-dose FEV1 measurements) at Week 8.~Spirometry, used to measure FEV1, was performed according to internationally accepted standards.~Definitions:~Baseline=Baseline values for pre-dose FEV1 were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FEV1=Forced expiratory volume in the 1st second;" (NCT03084718)
Timeframe: Baseline, Week 8

Intervention	Litres (Least Squares Mean)
Treatment A (CHF 718 pMDI 100 µg TDD)	0.021
Treatment B (CHF 718 pMDI 400 µg TDD)	0.090
Treatment C (CHF 718 pMDI 800 µg TDD)	0.070
Treatment D (Placebo)	-0.023
Treatment E (QVAR^®, 320 µg TDD)	0.078

12-lead ECG Parameters - PR, QRS, QTcF - Change From Baseline.

"12-lead electrocardiogram (12-lead ECG) parameters - PR, QRS, QTcF intervals - were measured at baseline (Day 1) and Week 8.~Changes from baseline.~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0); QTcF=Fridericia-corrected QT interval; msec=Millisecond;" (NCT03084718)
Timeframe: Baseline, Week 8

,,,,

Intervention	msec (Mean)
	PR	QRS	QTcF
Treatment A (CHF 718 pMDI 100 µg TDD)	-2.6	0.1	1.6
Treatment B (CHF 718 pMDI 400 µg TDD)	1.5	-1.3	0.7
Treatment C (CHF 718 pMDI 800 µg TDD)	-1.9	0.9	0.7
Treatment D (Placebo)	-1.3	-0.5	4.6
Treatment E (QVAR^®, 320 µg TDD)	1.0	-0.3	1.2

12-lead ECG Parameters - Prolonged QTcF - Change From Baseline

"Number of participants with prolonged QTcF. Change from baseline.~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; QTcF=Fridericia-corrected QT interval;" (NCT03084718)
Timeframe: Baseline, Week 8

,,,,

Intervention	Participants (Count of Participants)
	QTcF > 30 msec	QTcF > 60 msec
Treatment A (CHF 718 pMDI 100 µg TDD)	6	1
Treatment B (CHF 718 pMDI 400 µg TDD)	4	1
Treatment C (CHF 718 pMDI 800 µg TDD)	4	0
Treatment D (Placebo)	9	2
Treatment E (QVAR^®, 320 µg TDD)	3	1

Asthma Control Questionnaire-7© (ACQ-7) Score at Week 4 and Week 8 - Change From Baseline

"The ACQ consists of 7 items: 6 simple self-administered questions referring to asthma control and rescue treatment usage with 1 week recall, and a 7th item consisting of the percent (%) predicted FEV1 completed by clinic staff. Scoring uses a 7-point scale: 0 = totally controlled and 6 = severely uncontrolled. The ACQ score was calculated as the average of all 7 items.~Definitions:~ACQ-7 score=Asthma Control Questionnaire-7©; Information regarding the American Thoracic Society ACQ questionnaire is also available at: https://member.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php; Baseline ACQ-7 score = ACQ score recorded at V2 (Week 0) Day 1, before randomization; FEV1=Forced expiratory volume in the 1st second;" (NCT03084718)
Timeframe: Baseline, Week 4, Week 8

,,,,

Intervention	score on a scale (Least Squares Mean)
	Week 4	Week 8
Treatment A (CHF 718 pMDI 100 µg TDD)	-0.43	-0.53
Treatment B (CHF 718 pMDI 400 µg TDD)	-0.53	-0.58
Treatment C (CHF 718 pMDI 800 µg TDD)	-0.49	-0.66
Treatment D (Placebo)	-0.27	-0.43
Treatment E (QVAR^®, 320 µg TDD)	-0.47	-0.64

Average Use of Rescue Medication - Change From Baseline

"Change from baseline in average use of rescue medication, during Inter-visit period 1, Inter-visit period 2, Entire treatment period.~Definitions:~Baseline=For the efficacy variable -- average use of rescue medication -- derived from the electronic diary (eDiary), baseline values were the averages recorded during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

,,,,

Intervention	puffs/day (Least Squares Mean)
	Inter-visit period 1	Inter-visit period 2	Entire treatment period
Treatment A (CHF 718 pMDI 100 µg TDD)	-0.11	-0.12	-0.11
Treatment B (CHF 718 pMDI 400 µg TDD)	-0.27	-0.35	-0.31
Treatment C (CHF 718 pMDI 800 µg TDD)	-0.14	-0.25	-0.20
Treatment D (Placebo)	0.07	0.01	0.04
Treatment E (QVAR^®, 320 µg TDD)	-0.13	-0.18	-0.15

Overall Daily Asthma Symptoms Scores - Change From Baseline

"Overall daily asthma symptoms scores - Change From Baseline (am and pm).~Subjects had to record asthma symptom score (overall symptoms, cough, wheeze, chest tightness and breathlessness) in the am (night-time asthma symptom score) and in the pm (daytime asthma symptom score). These data were collected in the subject's diary. Daily asthma symptoms score were performed separately for am score and pm score and also as a total, where the total equals the sum of the am and pm scores. Degree of asthma symptoms by score: 0=None, 1=Mild, 2=Moderate, and 3=Severe.~Baseline=Averages values during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

,,,,

Intervention	score on a scale (Least Squares Mean)
	Inter-visit period 1	Inter-visit period 2	Entire treatment period
Treatment A (CHF 718 pMDI 100 µg TDD)	-0.1	-0.1	-0.1
Treatment B (CHF 718 pMDI 400 µg TDD)	-0.1	-0.1	-0.1
Treatment C (CHF 718 pMDI 800 µg TDD)	-0.1	-0.1	-0.1
Treatment D (Placebo)	0.0	-0.0	0.0
Treatment E (QVAR^®, 320 µg TDD)	-0.1	-0.1	-0.1

Percentage (%) of Asthma Control Days - Change From Baseline

"Change from baseline in percentage (%) of asthma control days, during Inter-visit period 1, Inter-visit period 2, Entire treatment period.~This outcome measure was calculated according to the following definition: Days with a total daily morning + evening asthma score = 0 AND No rescue medication use.~Definitions:~Baseline=For the efficacy variable -- asthma control days -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

,,,,

Intervention	% of asthma control days (Least Squares Mean)
	Inter-visit period 1	Inter-visit period 2	Entire treatment period
Treatment A (CHF 718 pMDI 100 µg TDD)	7.3	14.3	10.8
Treatment B (CHF 718 pMDI 400 µg TDD)	10.6	16.3	13.4
Treatment C (CHF 718 pMDI 800 µg TDD)	10.4	17.5	13.9
Treatment D (Placebo)	5.0	10.5	7.7
Treatment E (QVAR^®, 320 µg TDD)	12.8	20.63	16.7

Percentage (%) of Asthma Symptoms-free Days - Change From Baseline

"Change from baseline in Percentage (%) of asthma symptoms-free days.~Asthma symptoms-free days is the number of days with a total asthma score=0 (daily morning plus evening asthma score).~Subjects recorded asthma symptom score as described in the Outcome measure #7.~Definitions:~Baseline=For the efficacy variables -- daytime and night-time asthma symptom scores -- derived from the eDiary, baseline values were the averages/percentages recorded during the run-in period;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

,,,,

Intervention	% of of asthma symptom-free days (Least Squares Mean)
	Inter-visit period 1	Inter-visit period 2	Entire treatment period
Treatment A (CHF 718 pMDI 100 µg TDD)	8.6	16.4	12.5
Treatment B (CHF 718 pMDI 400 µg TDD)	10.5	17.0	13.8
Treatment C (CHF 718 pMDI 800 µg TDD)	10.1	17.2	13.6
Treatment D (Placebo)	5.7	11.7	8.7
Treatment E (QVAR^®, 320 µg TDD)	12.8	21.2	17.0

Percentage (%) of Rescue Medication-free Days - Change From Baseline

"Change from baseline in percentage (%) of rescue medication-free days. An increased value indicates improvement from baseline.~Definitions:~Baseline=For the efficacy variable -- percentage (%) of rescue medication-free days -- derived from the electronic diary (eDiary), baseline values were the averages/percentages recorded during the run-in period.~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

,,,,

Intervention	% of rescue medication-free days (Least Squares Mean)
	Inter-visit period 1	Inter-visit period 2	Entire treatment period
Treatment A (CHF 718 pMDI 100 µg TDD)	5.9	8.9	7.4
Treatment B (CHF 718 pMDI 400 µg TDD)	9.0	13.1	11.1
Treatment C (CHF 718 pMDI 800 µg TDD)	6.1	10.0	8.1
Treatment D (Placebo)	1.5	4.1	2.8
Treatment E (QVAR^®, 320 µg TDD)	7.7	11.2	9.5

Pre-dose Morning FVC at Week 4 and 8 - Change From Baseline

"Change from baseline in pre-dose morning FVC at Week 4 and 8.~Spirometry, used to measure FVC, was performed according to internationally accepted standards.~Definitions:~Baseline=Baseline values for pre-dose FVC were the average of measurements taken at V2 (Week 0) at 45 minutes and 15 minutes pre-dose; FVC=Forced vital capacity;" (NCT03084718)
Timeframe: Baseline, Week 4, Week 8

,,,,

Intervention	Litres (Least Squares Mean)
	Week 4	Week 8
Treatment A (CHF 718 pMDI 100 µg TDD)	0.036	0.014
Treatment B (CHF 718 pMDI 400 µg TDD)	0.099	0.089
Treatment C (CHF 718 pMDI 800 µg TDD)	0.066	0.036
Treatment D (Placebo)	0.023	-0.016
Treatment E (QVAR^®, 320 µg TDD)	0.056	0.063

Pre-dose Peak Expiratory Flow (PEF) (L/Min) (Morning and Evening) - Change From Baseline

"Change from baseline in pre-dose Peak Expiratory Flow (PEF) (Liters/min), morning and evening measurements.~Definitions:~Baseline=For the efficacy variable -- morning and evening PEF -- derived from the eDiary, the baseline values were the averages/percentages recorded during the run-in period; PEF=evening peak expiratory flow;~Inter-visit period 1=Starts from the pm assessment of the Start of the Randomized Treatment Period to the am assessment at Visit 3 (Week 4);~Inter-visit Period 2=Starts from the pm assessment of the day the subject returns to the clinic (Visit 3) to the am assessment of the date of Visit 4 (Week 8);~Entire treatment period=Average of 8 weeks;~am=morning pm=evening" (NCT03084718)
Timeframe: Baseline (average of the 2-week run-in period); Inter-visit period 1 (average of the first 4 weeks); Inter-visit period 2 (average of the last 4 weeks); Entire treatment period (average of 8 weeks)

,,,,

Intervention	Liters/min (Least Squares Mean)
	Inter-visit period 1	Inter-visit period 2	Entire treatment period
Treatment A (CHF 718 pMDI 100 µg TDD)	-2	-4	-3
Treatment B (CHF 718 pMDI 400 µg TDD)	-3	3	0.3
Treatment C (CHF 718 pMDI 800 µg TDD)	-4	-5	-4
Treatment D (Placebo)	-6	-4	-4.9
Treatment E (QVAR^®, 320 µg TDD)	0	2	1

Vital Signs (Systolic and Diastolic Blood Pressure) - Change From Baseline

"Vital signs (systolic and diastolic blood pressure) at baseline, week 4, and week 8.~Change from baseline.~Definitions:~Baseline=Baseline values were defined at visit 2 (Week 0) pre-dose; DBP=Diastolic blood pressure; SBP=Systolic blood pressure;" (NCT03084718)
Timeframe: Baseline, Week 4, Week 8

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Intervention	mmHg (Mean)
	SBP, Week 4	SBP, Week 8	DBP, Week 4	DBP, Week 8
Treatment A (CHF 718 pMDI 100 µg TDD)	-0.4	1.0	-0.1	0.8
Treatment B (CHF 718 pMDI 400 µg TDD)	1.0	2.5	0.2	1.0
Treatment C (CHF 718 pMDI 800 µg TDD)	0.5	0.8	-0.8	0.3
Treatment D (Placebo)	0.6	0.2	0.1	-0.5
Treatment E (QVAR^®, 320 µg TDD)	0.0	-0.9	0.8	1.2

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment

"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline was defined as the average AM and PM subject-reported iTNSS over the 4 days prior to randomization." (NCT01307319)
Timeframe: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

Intervention	units on a scale (Least Squares Mean)
BDP HFA 80 mcg/Day	-1.6
BDP HFA 160 mcg/Day	-1.7
Placebo Nasal Aerosol Once Daily	-1.0

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment

"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline was defined as the average AM and PM subject-reported rTNSS over the 4 days prior to randomization." (NCT01307319)
Timeframe: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Day 15

Intervention	units on a scale (Least Squares Mean)
BDP HFA 80 mcg/Day	-1.9
BDP HFA 160 mcg/Day	-2.0
Placebo Nasal Aerosol Once Daily	-1.2

Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who discontinued due to an AE was reported for each treatment group. (NCT03855189)
Timeframe: Up to 31 Days

Intervention	Participants (Count of Participants)
Mometasone Furoate (MF)	5
Beclomethasone Dipropionate (BDP)	2
Placebo	4

Number of Participants Who Experienced ≥1 Adverse Event

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants with at least one AE was reported for each treatment group. (NCT03855189)
Timeframe: Up to 31 Days

Intervention	Participants (Count of Participants)
Mometasone Furoate (MF)	60
Beclomethasone Dipropionate (BDP)	64
Placebo	78

Response To Therapy At Day 15 (Participant-Evaluated)

Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 15

Intervention	scores on a scale (Mean)
Mometasone Furoate (MF)	3.0
Beclomethasone Dipropionate (BDP)	2.7
Placebo	3.3

Response To Therapy At Day 15 (Physician-Evaluated)

Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. (NCT03855189)
Timeframe: Day 15

Intervention	scores on a scale (Mean)
Mometasone Furoate (MF)	3.0
Beclomethasone Dipropionate (BDP)	2.8
Placebo	3.3

Response To Therapy At Day 22 (Participant-Evaluated)

Intervention	scores on a scale (Mean)
Mometasone Furoate (MF)	2.9
Beclomethasone Dipropionate (BDP)	2.7
Placebo	3.1

Response To Therapy At Day 22 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
Mometasone Furoate (MF)	2.8
Beclomethasone Dipropionate (BDP)	2.7
Placebo	3.1

Response To Therapy At Day 29 (Participant-Evaluated)

Intervention	scores on a scale (Mean)
Mometasone Furoate (MF)	2.9
Beclomethasone Dipropionate (BDP)	2.6
Placebo	3.3

Response To Therapy At Day 29 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
Mometasone Furoate (MF)	2.9
Beclomethasone Dipropionate (BDP)	2.5
Placebo	3.2

Response To Therapy At Day 4 (Participant-Evaluated)

Intervention	scores on a scale (Mean)
Mometasone Furoate (MF)	3.3
Beclomethasone Dipropionate (BDP)	3.2
Placebo	3.6

Response To Therapy At Day 4 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
Mometasone Furoate (MF)	3.3
Beclomethasone Dipropionate (BDP)	3.2
Placebo	3.5

Response To Therapy At Day 8 (Participant-Evaluated)

Intervention	scores on a scale (Mean)
Mometasone Furoate (MF)	3.0
Beclomethasone Dipropionate (BDP)	2.7
Placebo	3.5

Response To Therapy At Day 8 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
Mometasone Furoate (MF)	3.0
Beclomethasone Dipropionate (BDP)	2.7
Placebo	3.5

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated)

Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 15

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 15
Beclomethasone Dipropionate (BDP)	2.2	-0.8
Mometasone Furoate (MF)	2.2	-0.7
Placebo	2.3	-0.5

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated)

Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 15

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 15
Beclomethasone Dipropionate (BDP)	2.2	-0.8
Mometasone Furoate (MF)	2.3	-0.7
Placebo	2.2	-0.5

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 22
Beclomethasone Dipropionate (BDP)	2.2	-0.9
Mometasone Furoate (MF)	2.2	-0.9
Placebo	2.3	-0.7

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 22
Beclomethasone Dipropionate (BDP)	2.2	-0.8
Mometasone Furoate (MF)	2.3	-0.9
Placebo	2.2	-0.6

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 29
Beclomethasone Dipropionate (BDP)	2.2	-0.9
Mometasone Furoate (MF)	2.2	-0.9
Placebo	2.3	-0.6

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 29
Beclomethasone Dipropionate (BDP)	2.2	-0.9
Mometasone Furoate (MF)	2.3	-0.9
Placebo	2.2	-0.6

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 4
Beclomethasone Dipropionate (BDP)	2.2	-0.6
Mometasone Furoate (MF)	2.2	-0.6
Placebo	2.3	-0.4

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 4
Beclomethasone Dipropionate (BDP)	2.2	-0.5
Mometasone Furoate (MF)	2.3	-0.6
Placebo	2.2	-0.3

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 8
Beclomethasone Dipropionate (BDP)	2.2	-0.8
Mometasone Furoate (MF)	2.2	-0.7
Placebo	2.3	-0.4

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 8
Beclomethasone Dipropionate (BDP)	2.2	-0.8
Mometasone Furoate (MF)	2.3	-0.7
Placebo	2.2	-0.3

Change From Baseline in the TNSS At Day 15 (Physician-Evaluated)

TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline (Day 1), Day 15

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 15
Beclomethasone Dipropionate (BDP)	7.9	-3.8
Mometasone Furoate (MF)	8.3	-3.3
Placebo	8.4	-2.6

Change From Baseline in the TNSS At Day 22 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 22
Beclomethasone Dipropionate (BDP)	7.9	-4.0
Mometasone Furoate (MF)	8.3	-3.9
Placebo	8.4	-3.2

Change From Baseline in the TNSS At Day 29 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 29
Beclomethasone Dipropionate (BDP)	7.9	-4.6
Mometasone Furoate (MF)	8.3	-4.1
Placebo	8.4	-3.2

Change From Baseline in the TNSS At Day 4 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 4
Beclomethasone Dipropionate (BDP)	7.9	-2.7
Mometasone Furoate (MF)	8.3	-2.4
Placebo	8.4	-1.8

Change From Baseline in the TNSS At Day 8 (Physician-Evaluated)

Intervention	scores on a scale (Mean)
	Baseline	Change From Baseline Day 8
Beclomethasone Dipropionate (BDP)	7.9	-3.8
Mometasone Furoate (MF)	8.3	-3.3
Placebo	8.4	-1.9

Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated)

TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching, as rated in their diary in the morning (AM) and evening (PM). The 4 individual symptom scores rated as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For the 15 day interval, participant individual daily scores were totaled and averaged over interval (AM and PM computed separately then averaged) and used to calculate the overall average change from Baseline. Participant average changes were then used to calculate the mean change for each arm for the interval. Average change from Baseline for Days 1-15 = average post-treatment score (Days 1-15) - Baseline average score (average of the Baseline AM/PM diary scores from 3 consecutive days prior to Baseline visit). Negative changes from baseline indicate a decrease in symptom severity. (NCT03855189)
Timeframe: Baseline, and Days 1 through 15 (average of 15 days of treatment)

Intervention	score on a scale (Mean)
	Baseline	Change from Baseline Days 1-15
Beclomethasone Dipropionate (BDP)	7.3	-2.8
Mometasone Furoate (MF)	7.6	-2.3
Placebo	7.6	-1.5

Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two Week Treatment Period

"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to the assessment, twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping). The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement." (NCT00854360)
Timeframe: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Intervention	units on a scale (Least Squares Mean)
BDP HFA 80 µg/Day	-1.77
BDP HFA 160 µg/Day	-1.71
BDP HFA 320 µg/Day	-2.10
Placebo	-1.50

Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period

"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement." (NCT00854360)
Timeframe: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Intervention	units on a scale (Least Squares Mean)
BDP HFA 80 µg/Day	-1.88
BDP HFA 160 µg/Day	-1.87
BDP HFA 320 µg/Day	-2.22
Placebo	-1.59

Change From Baseline in Morning 24-hour Reflective Non-nasal Symptom Score Over the Two-week Treatment Period

"Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes, redness of eyes and itching of ears or palate) for the past 24 hours each morning using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities or sleeping).~Total non-nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement." (NCT00854360)
Timeframe: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Intervention	units on a scale (Least Squares Mean)
BDP HFA 80 µg/Day	-1.55
BDP HFA 160 µg/Day	-1.49
BDP HFA 320 µg/Day	-1.91
Placebo	-1.51

Change From Baseline in Morning 24-hour Reflective Ocular Symptom Score Over the Two-week Treatment Period

"Participants recorded the severity of their symptoms (itching/burning eyes, tearing/watering eyes and redness of eyes) for the past 24 hours each morning using the following scale:~0=absent (no sign/symptoms); 1=mild (sign/symptom present, minimal awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptom hard to tolerate, interfere with daily activities or sleeping).~The total ocular symptom score (sum of 3 symptom scores) ranges from 0 to 9 (worst symptoms). A negative change from Baseline score indicates symptom improvement." (NCT00854360)
Timeframe: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Intervention	units on a scale (Least Squares Mean)
BDP HFA 80 µg/Day	-1.16
BDP HFA 160 µg/Day	-1.11
BDP HFA 320 µg/Day	-1.46
Placebo	-1.17

Change From Baseline in Morning Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period

Change from Baseline in the morning patient-reported instantaneous TNSS. Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 10 minutes (prior to the assessment) in the morning on a scale from 0 (mild symptoms) to 3 (severe symptoms). The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement. (NCT00854360)
Timeframe: Baseline (Day -6 to 0) and Days 1-15 (2-week Treatment Period)

Intervention	units on a scale (Least Squares Mean)
BDP HFA 80 µg/Day	-1.76
BDP HFA 160 µg/Day	-1.71
BDP HFA 320 µg/Day	-2.14
Placebo	-1.31

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates symptom improvement. (NCT00854360)
Timeframe: Baseline and Week 2

Intervention	units on a scale (Least Squares Mean)
BDP HFA 80 µg/Day	-1.30
BDP HFA 160 µg/Day	-1.33
BDP HFA 320 µg/Day	-1.62
Placebo	-1.22

Number of Participants With A Significant Change in Gene Expression in the Airway Epithelium and Alveolar Macrophages at Days 7 and 14

The primary study endpoint is a change in the gene expression in the airway epithelium or alveolar macrophages of healthy smokers following treatment with beclomethasone. Airway epithelium and alveolar macrophages are processed to yield high quality RNA. Complementary DNA (cDNA) is transcribed from the RNA in vitro and the product is hybridized onto gene microarray chips. The chip is then scanned and the image analyzed using the Affymetrix Microarray suite version 5 (MAS5) algorithm. Using GeneSpring software the data is normalized and differential expression is determined by fold change (up or down regulation) of the individual genes by comparing the geometric mean expression value from the airway epithelium and alveolar macrophages obtained from Day 7 and Day 14 following initiation of therapy to baseline values. (NCT00826748)
Timeframe: Analysis will be done on samples collected on Day 7 and Day 14 following initiation of therapy compared to baseline values obtained on the day prior to initiation of treatment.

Intervention	Participants (Count of Participants)
	Small Airway Epithelium	Alveolar Macrophages
Non-Smokers	NA	NA
Non-Treated Smokers	NA	NA
Treated Smokers	0	0

Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant

Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity. (NCT03879772)
Timeframe: Baseline and Days 1 through 15 (average over 15 days)

,,,,

Intervention	Scores on a scale (Mean)
	Baseline	Change From Baseline Days 1 to 15
BDP 84 mcg BID	6.6	-1.9
MFNS 100 mcg QD	6.9	-1.9
MFNS 200 mcg QD	6.9	-1.8
MFNS 25 mcg QD	6.3	-1.5
Placebo	6.8	-1.2

Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant

,,,,

Intervention	Scores on a scale (Mean)
	Baseline	Change From Baseline Days 16 to 29
BDP 84 mcg BID	6.6	-2.6
MFNS 100 mcg QD	6.9	-2.8
MFNS 200 mcg QD	6.9	-2.7
MFNS 25 mcg QD	6.3	-2.1
Placebo	6.8	-1.7

Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator

The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. (NCT03879772)
Timeframe: Baseline (Day 1) and Day 8

,,,,

Intervention	Scores on a scale (Mean)
	Baseline	Change From Baseline Day 8
BDP 84 mcg BID	8.0	-2.8
MFNS 100 mcg QD	8.1	-2.8
MFNS 200 mcg QD	7.9	-2.8
MFNS 25 mcg QD	7.8	-2.8
Placebo	8.0	-1.9

Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator

The mean change from baseline at study day 15 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. (NCT03879772)
Timeframe: Baseline (Day 1) and Day 15

,,,,

Intervention	Scores on a scale (Mean)
	Baseline	Change From Baseline Day 15
BDP 84 mcg BID	8.0	-3.5
MFNS 100 mcg QD	8.1	-3.0
MFNS 200 mcg QD	7.9	-3.1
MFNS 25 mcg QD	7.8	-2.9
Placebo	8.0	-2.4

Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator

The mean change from baseline at study day 29 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. (NCT03879772)
Timeframe: Baseline (Day 1) and Day 29

,,,,

Intervention	Scores on a scale (Mean)
	Baseline	Change From Baseline Day 29
BDP 84 mcg BID	8.0	-3.7
MFNS 100 mcg QD	8.1	-3.7
MFNS 200 mcg QD	7.9	-3.8
MFNS 25 mcg QD	7.8	-3.1
Placebo	8.0	-2.5

Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator

The mean change from baseline at study day 4 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. (NCT03879772)
Timeframe: Baseline (Day 1) and Day 4

,,,,

Intervention	Scores on a scale (Mean)
	Baseline	Change From Baseline Day 4
BDP 84 mcg BID	8.0	-2.4
MFNS 100 mcg QD	8.1	-2.0
MFNS 200 mcg QD	7.9	-2.0
MFNS 25 mcg QD	7.8	-2.2
Placebo	8.0	-1.3

Asthma Control Questionnaire (ACQ)

Change between placebo salmeterol and active salmeterol for ACQ, where ACQ ranges from 0 (best asthma control) to 6 (worst asthma control). (NCT00200967)
Timeframe: Clinic visits at weeks 0 and 18 of each treatment period

Intervention	units on a scale (Least Squares Mean)
B16 Arg/Arg	0.13
B16 Gly/Gly	0.11

Asthma Symptoms

Change between placebo salmeterol and active salmeterol for asthma symptoms (0=absent, 1=mild, 2=moderate, 3=severe). (NCT00200967)
Timeframe: Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period

Intervention	units on a scale (Mean)
B16 Arg/Arg	0.04
B16 Gly/Gly	0.00

Evening (PM) Peak Expiratory Flow (PEF) Rate

Change between placebo salmeterol and active salmeterol for PM PEF rate (NCT00200967)
Timeframe: Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period

Intervention	liters per minute (Least Squares Mean)
B16 Arg/Arg	-25
B16 Gly/Gly	-24

Exhaled Breath Condensate (EBC)

Change between placebo salmeterol and active salmeterol for EBC (NCT00200967)
Timeframe: Clinic visits at weeks 0, 10, and 18 of each treatment period

Intervention	pH (Least Squares Mean)
B16 Arg/Arg	-0.10
B16 Gly/Gly	-0.03

Exhaled Nitric Oxide (eNO)

Change between placebo salmeterol and active salmeterol for eNO (NCT00200967)
Timeframe: Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period

Intervention	parts per billion (Geometric Mean)
B16 Arg/Arg	0.12
B16 Gly/Gly	-0.02

Methacholine Provocative Concentration 20 (PC20)

Change between placebo salmeterol and active salmeterol for methacholine PC20 (NCT00200967)
Timeframe: Clinic visits at weeks 0 and 18 of each treatment period

Intervention	milligrams per milliliter (Geometric Mean)
B16 Arg/Arg	0.06
B16 Gly/Gly	-1.27

Morning (AM) Peak Expiratory Flow (PEF) Rate

Change between placebo salmeterol and active salmeterol for AM PEF rate (NCT00200967)
Timeframe: Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period

Intervention	liters per minute (Least Squares Mean)
B16 Arg/Arg	-21
B16 Gly/Gly	-22

Peak Expiratory Flow (PEF) Variability

Change between placebo salmeterol and active salmeterol for PEF variability, where PEF variability is defined as 100% x (PM PEF - AM PEF)/(PM PEF) (NCT00200967)
Timeframe: Measured daily using a hand-held peak flow meter, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period

Intervention	percentage (Least Squares Mean)
B16 Arg/Arg	0.2
B16 Gly/Gly	0.7

Rescue Medication (Ipratropium and Albuterol) Use

Change between placebo salmeterol and active salmeterol for rescue medication use (NCT00200967)
Timeframe: Recorded daily on a diary card, and then averaged between weeks 0, 2, 6, 10, 14, and 18 of each treatment period

Intervention	puffs per day (Mean)
B16 Arg/Arg	0.2
B16 Gly/Gly	0.0

Spirometry Forced Expiratory Volume in One Second (FEV1), Pre-bronchodilator

Change between placebo salmeterol and active salmeterol for Spirometry FEV1, pre-bronchodilator (NCT00200967)
Timeframe: Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period

Intervention	liters (Least Squares Mean)
B16 Arg/Arg	-0.08
B16 Gly/Gly	-0.04

Spirometry Forced Vital Capacity (FVC), Pre-bronchodilator

Change between placebo salmeterol and active salmeterol for Spirometry FVC, pre-bronchodilator (NCT00200967)
Timeframe: Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period

Intervention	liters (Least Squares Mean)
B16 Arg/Arg	-0.04
B16 Gly/Gly	-0.03

Spirometry Peak Expiratory Flow (PEF) Rate, Pre-bronchodilator

Change between placebo salmeterol and active salmeterol for Spirometry PEF rate, pre-bronchodilator (NCT00200967)
Timeframe: Clinic visits at weeks 0, 2, 6, 10, 14, and 18 of each treatment period

Intervention	liters per minute (Least Squares Mean)
B16 Arg/Arg	-17
B16 Gly/Gly	-17

The 24-hour Serum Cortisol Weighted Mean After 42 Days of Treatment

"Geometric mean serum cortisol weighted mean values were calculated at baseline and after 6 weeks (42 days) of treatment. The geometric mean ratio of week 6 / baseline is reported. The primary outcome compares the BDP HFA and Placebo treatment arms. The comparison of active control (Placebo/Prednisone) and Placebo treatment arms is an other pre-specified outcome." (NCT01133626)
Timeframe: Day 0 (Baseline), Day 42

Intervention	ratio (Geometric Mean)
BDP HFA 320 µg/Day	0.90
Placebo	0.95
Placebo/Prednisone	0.31

Health Related Quality of Life

Quality of life assessed using the Paediatric Caregivers Asthma Quality of Life Questionnaire (PACQLQ). The scores are from 1.0-7.0, higher value is a better outcome. We calculated the actual score at baseline and at 4 months. A change in score of 0.5 is considered clinically significant. We recorded actual value at baseline and actual value at 4 months. (NCT02517099)
Timeframe: 4 months

Intervention	score on a scale (Median)
Pathological Phenotype	6.7
Clinical Guidelines	6.4

Number of Courses of Oral Steroids

Number of steroid courses needed during 4 months for any acute symptoms. (NCT02517099)
Timeframe: 4 months and up to 1 year later

Intervention	number of steroid courses (Number)
Pathological Phenotype	13
Clinical Guidelines	14

Number of Unscheduled Healthcare Visits (UHCV)

Actual number of unscheduled healthcare visits (UHCV) includes GP, A&E or hospital admission. This is median number of visits in 4 months - with range. (NCT02517099)
Timeframe: 4 months

Intervention	number of visits (Median)
Pathological Phenotype	0.5
Clinical Guidelines	0.5

Symptom Days

Number of days with symptoms during 4 months (NCT02517099)
Timeframe: 4 months

Intervention	days (Median)
Pathological Phenotype	9
Clinical Guidelines	12

Change Between Week 14 and Week 0 in Asthma Symptoms

"Asthma symptoms were recorded as 0 (absent = no symptom )~(mild = symptom was minimally troublesome, i.e. not sufficient to interfere with normal daily activity or sleep)~(moderate = symptom was sufficiently troublesome to interfere with normal daily activity or sleep)~(severe = symptom was so severe as to prevent normal activity and/or sleep )" (NCT00565266)
Timeframe: Asthma symptoms were measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.

Intervention	units on a scale (Least Squares Mean)
Tio + 1xICS	-0.09
LABA + 1xICS	-0.04
2xICS	0.03

Change Between Week 14 and Week 0 in the Albuterol Rescue Puffs Per Day

Total number of puffs from the albuterol (rescue) inhaler during the previous 24 hours (excluding those puffs for preventive use). (NCT00565266)
Timeframe: Albuterol rescue puffs were measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.

Intervention	puffs per day (Least Squares Mean)
Tio + 1xICS	-0.11
LABA + 1xICS	-0.16
2xICS	-0.07

Change Between Week 14 and Week 0 in the Asthma Control Questionnaire Score

Scores on the Asthma Control Questionnaire range from 0 to 6, with a higher score indicating worse asthma control. (NCT00565266)
Timeframe: The asthma control questionnaire score was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.

Intervention	units on a scale (Least Squares Mean)
Tio + 1xICS	-0.22
LABA + 1xICS	-0.31
2xICS	-0.03

Change Between Week 14 and Week 0 in the Asthma Quality-of-life Questionnaire Score

Scores on the Asthma Quality-of-Life Questionnaire range from 1 to 7, with a higher score indicating a better quality of life. (NCT00565266)
Timeframe: The asthma quality-of-life questionnaire score was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.

Intervention	units on a scale (Least Squares Mean)
Tio + 1xICS	0.15
LABA + 1xICS	0.28
2xICS	0.05

Change Between Week 14 and Week 0 in the Forced Expiratory Volume in One Second (FEV1)

(NCT00565266)
Timeframe: FEV1 was measured on four occasions during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.

Intervention	liters (Least Squares Mean)
Tio + 1xICS	0.12
LABA + 1xICS	0.01
2xICS	0.02

Change Between Week 14 and Week 0 in the Morning (AM) Peak Expiratory Flow (PEF)

(NCT00565266)
Timeframe: AM PEF was measured daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.

Intervention	Liters per minute (Least Squares Mean)
Tio + 1xICS	24.4
LABA + 1xICS	18.0
2xICS	-1.4

Change Between Week 14 and Week 0 in the Proportion of Asthma Control Days

An asthma control day was defined as a day in which there were no symptoms and no albuterol (rescue) puffs. (NCT00565266)
Timeframe: An asthma control day was determined daily during each of the three 14-week treatment periods. The primary analysis constructed the change between week 14 and week 0.

Intervention	proportion of asthma control days (Least Squares Mean)
Tio + 1xICS	0.13
LABA + 1xICS	0.14
2xICS	0.05

Short-term Lower Leg Growth During Treatment With Flovent Discus 100 mcg BID or QVAR 80 mcg BID.

Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma during treatment with Flovent Discus 100 mcg BID or QVAR 80 mcg BID. (NCT01520688)
Timeframe: 1 yr

Intervention	mm/wk (Mean)
Flovent Discus 100 mcg BID	0.37
QVAR 80 mcg BID	0.38

Short-term Lower Leg Growth During Treatment With Flovent Diskus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID.

Short-term lower leg growth as assessed by knemometry in pediatric subjects with mild asthma treated with Flovent Discus 100 mcg BID or Pulmicort Flexhaler 180 mcg BID. (NCT01520688)
Timeframe: 1 yr

Intervention	mm/wk (Mean)
Flovent Discus 100 mcg BID	0.37
Pulmicort Flexhaler 180 mcg BID	0.21

Change From Baseline in Average AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Six-week Treatment Period

"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the 10 minutes prior to assessment twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (awareness of symptoms, bothersome but tolerable); 3=severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of the 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement." (NCT01134705)
Timeframe: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-2.1
Placebo	-1.4

Change From Baseline in Average AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Six-week Treatment Period

"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) over the past 12 hours twice daily (AM & PM) using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, awareness, easily tolerated); 2=moderate (awareness of sign/symptom, bothersome but tolerable); 3=severe (sign/symptoms hard to tolerate, interfere with daily activities and/or sleeping).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from Baseline score indicates symptom improvement." (NCT01134705)
Timeframe: Baseline (Days -3 to 0) and Days 1-43 (6-week Treatment Period)

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-2.5
Placebo	-1.6

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7. A negative change from Baseline score indicates improvement. (NCT01134705)
Timeframe: Baseline and Week 6

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-1.5
Placebo	-0.9

Adenosine Challenge Test

Adenosine challenge test were measured and described as PC 20 - the concentration that corresponded to a FEV1 impairment equal or bigger than 20%. The stage was also recorded (NCT01006655)
Timeframe: ten weeks

Intervention	mg/ml (Mean)
Placebo First, Adenosine Challenge Test	18.46
Qvar First, Adenosine Challenge Test	142.61

Change Between Week 44 and Week 0 in Rescue Albuterol Puffs Per Day

(NCT00394329)
Timeframe: Rescue albuterol puffs were measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.

Intervention	count of the number of puffs per day (Least Squares Mean)
A: Daily ICS + Rescue ICS	0.26
B: Daily ICS	0.24
C: Rescue ICS	0.26
D: Placebo	0.18

Change Between Week 44 and Week 0 in the Asthma Control Days

(NCT00394329)
Timeframe: An asthma control day was determined daily during each of the 44-week treatment periods. The primary analysis constructed the change between week 14 and week 0.

Intervention	proportion of asthma control days (Least Squares Mean)
A: Daily ICS + Rescue ICS	-0.006
B: Daily ICS	-0.021
C: Rescue ICS	-0.064
D: Placebo	-0.034

Change Between Week 44 and Week 0 in the Asthma Control Test (ACT)

The ACT consisted of five questions, each ranging from 1 (worst) to 5 (best). The five questions were summed to yield an overall score that ranged from 5 (worst) to 25 (best). (NCT00394329)
Timeframe: The ACT was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.

Intervention	units on a scale (Least Squares Mean)
A: Daily ICS + Rescue ICS	0.17
B: Daily ICS	-0.15
C: Rescue ICS	-0.57
D: Placebo	-0.76

Change Between Week 44 and Week 0 in the Asthma-specific Quality of Life Assessment

The asthma-specific quality of life scale ranged from 1 (worst) to 7 (best) (NCT00394329)
Timeframe: The asthma-specific quality of life assessment was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.

Intervention	units on a scale (Least Squares Mean)
A: Daily ICS + Rescue ICS	0.15
B: Daily ICS	0.07
C: Rescue ICS	0.05
D: Placebo	-0.03

Change Between Week 44 and Week 0 in the Evening Peak Expiratory Flow Rate Variability (PEFR)

(NCT00394329)
Timeframe: Evening PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.

Intervention	liters per minute (Least Squares Mean)
A: Daily ICS + Rescue ICS	16.2
B: Daily ICS	14.9
C: Rescue ICS	12.9
D: Placebo	20.6

Change Between Week 44 and Week 0 in the Exhaled Nitric Oxide (eNO) Measured in Parts Per Billion

(NCT00394329)
Timeframe: eNO was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.

Intervention	parts per billion (Least Squares Mean)
Daily ICS + Rescue ICS	-0.08
Daily ICS	0.07
Rescue ICS	0.58
Placebo	0.34

Change Between Week 44 and Week 0 in the Morning Peak Expiratory Flow Rate (PEFR)

(NCT00394329)
Timeframe: Morning PEFR was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.

Intervention	liters per minute (Least Squares Mean)
A: Daily ICS + Rescue ICS	17.7
B: Daily ICS	16.3
C: Rescue ICS	16.5
D: Placebo	21.1

Change Between Week 44 and Week 0 in the Pre-bronchodilator Forced Expiratory Volume in One Second (FEV!)

(NCT00394329)
Timeframe: Pre-bronchodilator FEV1 was measured on seven occasions during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.

Intervention	liters (Least Squares Mean)
A: Daily ICS + Rescue ICS	0.104
B: Daily ICS	0.113
C: Rescue ICS	0.097
D: Placebo	0.063

Change Between Week 44 and Week 0 Peak Expiratory Flow Rate (PEFR) Variability

PEFR variability represents the relative change between the evening and morning PEFR measurements, so it could be a positive or negative number. It was measured daily during the 44-week treatment period. Specifically, the PEFR variability on a specific day is defined as 100% x (evening PEFR - morning PEFR)/{0.5*(evening PEFR + morning PEFR)} (NCT00394329)
Timeframe: PEFR variability was measured daily during the 44-week treatment period. The primary analysis constructed the change between week 44 and week 0.

Intervention	relative change (AM and PM peak flow) (Least Squares Mean)
A: Daily ICS + Rescue ICS	0.836
B: Daily ICS	-0.043
C: Rescue ICS	0.098
D: Placebo	0.894

Participants Experiencing an Asthma Exacerbation That Requires Systemic Corticosteroid Therapy

(NCT00394329)
Timeframe: Measured during the 44-week treatment period

Intervention	participants (Number)
A: Daily ICS + Rescue ICS	22
B: Daily ICS	20
C: Rescue ICS	25
D: Placebo	36

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age

"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period." (NCT01783548)
Timeframe: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6

Intervention	units on a scale (Least Squares Mean)
BDP Nasal Aerosol 80 mcg/Day	-2.07
Placebo Nasal Aerosol	-1.53

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age

"Instantaneous TNSS is an evaluation of symptom severity over the last 10 minutes prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study iTNSS values were defined as the average AM and PM subject-reported iTNSS during each time period." (NCT01783548)
Timeframe: Baseline (Day -4 to Day 1 predose), Days 1 (postdose) to Week 6

Intervention	units on a scale (Least Squares Mean)
BDP Nasal Aerosol 80 mcg/Day	-1.98
Placebo Nasal Aerosol	-1.39

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 4 To 11 Years Of Age

"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period." (NCT01783548)
Timeframe: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6

Intervention	units on a scale (Least Squares Mean)
BDP Nasal Aerosol 80 mcg/Day	-2.32
Placebo Nasal Aerosol	-1.71

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) Over The First 6 Weeks Of Treatment In Subjects 6 To 11 Years Of Age

"Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale:~0 = absent (no sign/symptom present)~1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated)~2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable)~3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms.~Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period." (NCT01783548)
Timeframe: Baseline (Day -4 to Day 1 predose), Day 1 (postdose) to Week 6

Intervention	units on a scale (Least Squares Mean)
BDP Nasal Aerosol 80 mcg/Day	-2.26
Placebo Nasal Aerosol	-1.60

Change in Asthma Control Test Score

Patients will be treated with 6 weeks of inhaled beclomethasone diproprionate (BD) treatment and the change in Asthma Control Test (ACT) quantified. The composite ACT score measured at each time point ranged from 5-25 (with higher scores reflective of better asthma control). Therefore, the absolute change in ACT score from before to after treatment could range from -20 to +20. (NCT01142947)
Timeframe: 6 weeks

Intervention	change in composite score (Mean)
Beclomethasone Dipropionate (BD)	3.32

Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 30 Weeks

"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 10 minutes (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement." (NCT00988247)
Timeframe: Baseline (Days -6 to 0), Day 1 to Week 30

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-2.9
Placebo	-2.0

Change From Baseline in Average Subject-Assessed 24-Hour Instantaneous Total Nasal Symptom Score (iTNSS) up to 52 Weeks

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-3.1
Placebo	-2.0

Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 30 Weeks

"Participants recorded the severity of their nasal symptoms (sneezing, runny nose, itchy nose and nasal congestion) in the past 24-hours (prior to the assessment) daily using the following scale:~0=absent (no sign/symptom); 1=mild (sign/symptom present, easily tolerated); 2=moderate (bothersome but tolerable); 3=severe (hard to tolerate, interfere with daily activities).~The total nasal symptom score (sum of 4 symptom scores) ranges from 0 to 12 (worst symptoms). A negative change from baseline score indicates improvement." (NCT00988247)
Timeframe: Baseline (Days -6 to 0), Day 1 to Week 30

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-3.4
Placebo	-2.4

Change From Baseline in Average Subject-Assessed 24-Hour Reflective Total Nasal Symptom Score (rTNSS) up to 52 Weeks

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-3.7
Placebo	-2.6

Change From Baseline to Week 30 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline

"The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7.~Week 30 scores were compared to baseline scores. A negative change score indicates improvement." (NCT00988247)
Timeframe: Day 0 (Baseline) and Week 30

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-2.2
Placebo	-1.9

Change From Baseline to Week 52 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline

"The adult RQLQ has 28 questions in 7 domains (activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional). Participants were asked to recall their experiences during the previous week and to give their responses on a 7-point scale (0 = Least severe to 6 = Extremely severe). The overall RQLQ score is the mean of all 28 responses, and ranges from 0 to 7.~Week 52 scores were compared to baseline scores. A negative change score indicates improvement." (NCT00988247)
Timeframe: Day 0 (Baseline) and Week 52

Intervention	units on a scale (Least Squares Mean)
BDP HFA 320 µg/Day	-2.0
Placebo	-1.5

Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12

The total daily asthma symptom score is the average of the daytime and nighttime scores analyzed using an mixed model for repeated measures (MMRM). Baseline was defined as the average of recorded morning and evening asthma symptom scores over the 7 days before randomization. Daytime Scores range from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities; Nighttime Scores range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The daily asthma symptom score was therefore 0 - 9 with 0=no symptoms during the day or night and 9=severe symptoms both day and night. (NCT02040766)
Timeframe: Day 1 (baseline), weeks 1-12

Intervention	units on a scale (Least Squares Mean)
Placebo BAI and MDI	-0.27
BDP 80 mcg BAI	-0.44
BDP 160 mcg BAI	-0.36
BDP 80 mcg MDI	-0.31
BDP 160 mcg MDI	-0.36

Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12

The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) across the 12 weeks was analyzed using a mixed model for repeated measures (MMRM). (NCT02040766)
Timeframe: Day 1 (baseline), weeks 1-12

Intervention	Number of inhalations (Least Squares Mean)
Placebo BAI and MDI	-0.36
BDP 80 mcg BAI	-0.72
BDP 160 mcg BAI	-0.50
BDP 80 mcg MDI	-0.41
BDP 160 mcg MDI	-0.54

Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period

The analysis of change from baseline in the weekly average of daily evening PEF across the 12-week treatment period was performed using a mixed model for repeated measures (MMRM) with effects due to baseline weekly average of daily evening PEF. (NCT02040766)
Timeframe: Day 1 (baseline), weeks 1-12

Intervention	liters (Least Squares Mean)
Placebo BAI and MDI	1.4
BDP 80 mcg BAI	13.1
BDP 160 mcg BAI	11.4
BDP 80 mcg MDI	11.3
BDP 160 mcg MDI	10.1

Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period

The analysis of change from baseline in weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF calculated across the 12-week treatment period was performed using a mixed model for repeated measures (MMRM) with effects due to baseline weekly average of daily trough morning PEF. (NCT02040766)
Timeframe: Day 1 (baseline), weeks 1-12

Intervention	liters (Least Squares Mean)
Placebo BAI and MDI	4.3
BDP 80 mcg BAI	15.6
BDP 160 mcg BAI	12.8
BDP 80 mcg MDI	11.9
BDP 160 mcg MDI	10.8

Kaplan-Meier Estimates For Time to Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-week Treatment Period

"Time to withdrawal due to meeting stopping criteria was defined as number of days elapsed from the date of first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria.~Kaplan-Meier estimates (median and 95% CI of the median) are not applicable if the proportion of participants withdrawn is less than 0.5." (NCT02040766)
Timeframe: Day 1 to 12 weeks

Intervention	Days (Median)
Placebo BAI and MDI	NA
BDP 80 mcg BAI	NA
BDP 160 mcg BAI	NA
BDP 80 mcg MDI	NA
BDP 160 mcg MDI	NA

Standardized Baseline-adjusted Trough Morning Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk))

Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. Baseline was defined as baseline trough morning percent predicted FEV1. Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest ('best attempt') FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used. (NCT02040766)
Timeframe: Day 1 (baseline), Weeks 2, 4, 8, 12

Intervention	liters (Least Squares Mean)
Placebo BAI and MDI	2.62
BDP 80 mcg BAI	5.43
BDP 160 mcg BAI	3.25
BDP 80 mcg MDI	3.54
BDP 160 mcg MDI	3.71

Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)

Asthma symptom scores are recorded in the patient's diary each morning and each evening before determining PEF and before administration of study or rescue medications. The Daytime Symptom Score (determined in the evening) has a range from 0=No symptoms during the day to 5=Symptoms so severe that I could not go to work or perform normal daily activities. The Nighttime Symptom Score (determined in the morning) has a range from 0=No symptoms during the night to 4=Symptoms so severe that I did not sleep at all. The total daily asthma symptom score is the average of the daytime and the nighttime scores (full scale is 0 - 4.5). The total daily asthma symptom score is missing if either the daytime or nighttime score is missing. Baseline was the average of recorded daily asthma symptom scores over 7 days prior to the first dose of study treatment. The weekly average was the sum of total daily asthma symptom scores over the 7 days divided by the number of non-missing assessments. (NCT02031640)
Timeframe: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12

Intervention	units on a scale (Least Squares Mean)
Placebo BAI and MDI	-0.058
BDP 320 mcg BAI	-0.207
BDP 640 mcg BAI	-0.159
BDP 320 mcg MDI	-0.247
BDP 640 mcg MDI	-0.274

Change From Baseline in the Weekly Average of Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol (Number of Inhalations) Over Weeks 1-12 Using a Mixed Model for Repeated Measures (MMRM)

"Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control. Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including the morning usage at the randomization visit.~Weekly average rescue medication data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). Weekly average over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline value, sex, age, time, treatment, and time-by-treatment interaction." (NCT02031640)
Timeframe: Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 1 to Week 12

Intervention	number of inhalations (Least Squares Mean)
Placebo BAI and MDI	0.478
BDP 320 mcg BAI	-0.226
BDP 640 mcg BAI	-0.213
BDP 320 mcg MDI	-0.173
BDP 640 mcg MDI	-0.323

Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)

"A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.~Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization.~Weekly average PEF data was generated using 7-day windows based on analysis days (after the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily evening peak PEF, sex, age, treatment, time, and time by treatment interaction." (NCT02031640)
Timeframe: Baseline: Days -7 to Day -1, Treatment: Day 1 to Week 12

Intervention	Liters/minute (Least Squares Mean)
Placebo BAI and MDI	-4.708
BDP 320 mcg BAI	4.439
BDP 640 mcg BAI	4.462
BDP 320 mcg MDI	-0.62
BDP 640 mcg MDI	5.594

Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Over the 12-week Treatment Period Using a Mixed Model for Repeated Measures (MMRM)

"A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. Daily trough morning PEF assessments were taken pre-dose and pre-rescue bronchodilator over the 12-week treatment period. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.~Baseline in trough morning PEF is defined as the average of recorded trough morning PEF assessments over the 7-day window before randomization, including the morning assessment on Day 1 before randomization.~Weekly average PEF data was generated using 7-day windows based on analysis days (before the first dose of double-blind study treatment). PEF over the 12 week treatment period was performed using a mixed-model for repeated measures (MMRM) with effects due to baseline weekly average of daily trough morning PEF, sex, age, treatment, time, and time by treatment interaction." (NCT02031640)
Timeframe: Baseline: Days -6 to Day 1 (pre-randomization), Treatment: Day 2 to Week 12

Intervention	Liters/minute (Least Squares Mean)
Placebo BAI and MDI	-5.524
BDP 320 mcg BAI	5.092
BDP 640 mcg BAI	2.895
BDP 320 mcg MDI	0.480
BDP 640 mcg MDI	6.988

Kaplan-Meier Estimates for Time to Withdrawal From Study Treatment Due to Meeting Stopping Criteria for Worsening Asthma

"Time to withdrawal due to meeting stopping criteria is defined as number of days elapsed from the date of the first dose of double-blind study treatment to the date of withdrawal due to meeting stopping criteria. Stopping criteria are:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at RV.~Based upon review of patient diary data, the patient has experienced any of the following during any 7-day period:~4+ days in which the highest (of 3 efforts) am PEF fall below the PEF stability limit calculated when randomized. The patient meets with the investigator who determines whether the FEV1 is consistent with worsening asthma;~3+ days in which 12+ inhalations/day of rescue medication were used~2+ days in which the patient experienced a nighttime asthma symptom score of more than 2~Clinical asthma exacerbation requiring (for example) the use of systemic corticosteroids, or the emergency room or hospitalization." (NCT02031640)
Timeframe: Day 1 - Week 12

Intervention	days (Median)
Placebo BAI or MDI	NA
BDP 320 mcg BAI	NA
BDP 640 mcg BAI	NA
BDP 320 mcg MDI	NA
BDP 640 mcg MDI	NA

Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

"A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.~An example of alert criteria is:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).~Other criteria as defined in the protocol." (NCT02031640)
Timeframe: Treatment period: Day 1 up to Week 12

Intervention	Participants (Count of Participants)
Placebo BAI or MDI	15
BDP 320 mcg BAI	3
BDP 640 mcg BAI	3
BDP 320 mcg MDI	5
BDP 640 mcg MDI	1

Standardized Baseline-adjusted Trough Morning Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time 0 to 12 Weeks (AUEC(0-12wk) )

"Trough morning FEV1 measurements were taken pre-dose and pre-rescue bronchodilator treatment for asthma. The baseline pulmonary function measurement was defined as the measurement obtained at randomization visit (Day 1). Pulmonary function measurements (including FEV1) were obtained electronically by spirometry. All pulmonary function test data were submitted to a central reading center for evaluation. The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 5 attempts) was used.~Baseline-adjusted FEV1 AUEC(0-12wk) were calculated using the trapezoidal rule.~The standardized baseline-adjusted FEV1 AUEC(0-12 wk) accommodates participants who dropped out of the study. Baseline-adjusted FEV1 AUEC(0-t weeks)/t, where t =12 weeks for patients who complete the FEV1 assessment at Week 12. For participants who dropped out early, t <12 weeks (2, 4, or 8 weeks)." (NCT02031640)
Timeframe: Day 1 (baseline), Weeks 2, 4, 8, 12

Intervention	Liters (Least Squares Mean)
Placebo BAI and MDI	0.056
BDP 320 mcg BAI	0.09
BDP 640 mcg BAI	0.101
BDP 320 mcg MDI	0.041
BDP 640 mcg MDI	0.096

The Effect of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Beconase AQ Nasal Spray & QVAR Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.

To evaulate the effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID versus Beconase AQ Nasal Spray 168 mcg BID and QVAR Inhalation Aerosol 40 mcg BID on- short-term lower leg growth as measured by knemometry in children with mild asthma and allergic rhinitis. (NCT01550471)
Timeframe: 1 yr

Intervention	mm/wk (Mean)
Alvesco and Omnaris	0.23
Beconase and QVAR	0.33

The Effects of Omnaris Nasal Spray & Alvesco Inhalation Aerosol vs Placebo Nasal Spray & Placebo Inhalation Aerosol on Short-term Lower Leg Growth Velocity as Measured by Knemometry in Pediatric Subjects w/ Mild Asthma & Allergic Rhinitis.

To evaluate growth suppressive effect of Omnaris Nasal Spray 200 mcg QD and Alvesco Inhalation Aerosol 80 BID as compared to Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID on short-term lower leg growth velocity as measured by knemometry in children with mild asthma and allergic rhinitis. (NCT01550471)
Timeframe: 1 yr

Intervention	mm/wk (Mean)
Omnaris & Alvesco	0.23
Placebo & Placebo	0.51

Change From Baseline in Weekly Average of Daily Trough Morning Forced Expiratory Volume in One Minute (FEV1) Rate Over the 6-Week Treatment Period

Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) FEV1 by handheld spirometer over the 6-week treatment period. FEV1 were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening FEV1 throughout the study. The spirometer was programmed to record the highest FEV1 obtained from 3 valid attempts. Baseline was defined as the average of recorded trough morning FEV1 assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction. (NCT02513160)
Timeframe: Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks

Intervention	milliliters (Least Squares Mean)
Placebo	-8
BAI 320 mcg/Day	162
BAI 640 mcg/Day	135
MDI 320 mcg/Day	125

Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 6-Week Treatment Period

Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF by handheld spirometer over the 6-week treatment period. PEF were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening PEF throughout the study. The spirometer was programmed to record the highest PEF obtained from 3 valid attempts. Baseline was defined as the average of recorded trough morning PEF assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction. (NCT02513160)
Timeframe: Timeframes: Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks

Intervention	liters/minute (Least Squares Mean)
Placebo	-10.0
BAI 320 mcg/Day	20.1
BAI 640 mcg/Day	11.9
MDI 320 mcg/Day	10.9

Change From Baseline in Weekly Average of Total Daily (24-Hour) Rescue Medication Use Over the 6-Week Treatment Period

Change from baseline in the weekly average of total daily (24-hour) use of albuterol/salbutamol inhalation aerosol over weeks 1 through 6. Patients recorded the number of inhalations (puffs used) of rescue medication (albuterol/salbutamol HFA MDI [90 mcg ex-actuator] or equivalent) each morning and evening in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value and was compared with the rescue medication use during the 6-week treatment period. (NCT02513160)
Timeframe: Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks

Intervention	number of inhalations (Least Squares Mean)
Placebo	0.37
BAI 320 mcg/Day	-0.73
BAI 640 mcg/Day	-0.66
MDI 320 mcg/Day	-0.66

Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 6-Week Treatment Period

Asthma symptom scores were recorded in the patient's diary each morning and evening before determining FEV1 and PEF and before administration of study or rescue medications. The Daytime Symptom Score was recorded in the evening on a scale of 0 (No symptoms during the day) to 5 (Symptoms so severe that I could not go to work or perform normal daily activities) plus the Nighttime Symptom Score in the morning on a scale of 0 (No symptoms during the night) to 4 (Symptoms so severe that I did not sleep at all) for a total score range of 0-9. Baseline was defined as the average of recorded daily asthma symptom scores (average of daytime and nighttime score) over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit. The LS means, difference of LS means and its 95% CI, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asth (NCT02513160)
Timeframe: Baseline (Day -7 to Day 0 which is part of the Run-in Period); Treatment Period from Day 0 up to 6 weeks

Intervention	units on a scale (Least Squares Mean)
Placebo	0.06
BAI 320 mcg/Day	-0.18
BAI 640 mcg/Day	-0.26
MDI 320 mcg/Day	-0.24

Count of Participants Withdrawn From Study Drug Treatment Due to Meeting Stopping Criteria for Worsening Asthma

"Number of participants who were withdrawn from study drug due to worsening asthma. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture was consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety. An example of an alert criteria is:~Morning FEV1 by handheld spirometer as measured at home falls below the FEV1 stability limit (FEV1 <80%) as calculated at the screening visit for the Run-in Period and at the randomization visit (Day 0) for the Treatment Period on 4 or more days out of any 7-day period." (NCT02513160)
Timeframe: Day 0 to Week 6

Intervention	Participants (Count of Participants)
Placebo	10
BAI 320 mcg/Day	1
BAI 640 mcg/Day	0
MDI 320 mcg/Day	1

Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 6 Weeks (AUEC(0-6wk))

The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-6wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit, each treatment visit (Weeks 2, 4 and 6) and any unscheduled visit (such as the early termination visit). The highest FEV1 value from 3 acceptable and 2 repeatable maneuvers (maximum of 8 attempts) was used. The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment. (NCT02513160)
Timeframe: Baseline (Day 0 of Treatment Period), weeks 2, 4, 6

Intervention	milliliters (Least Squares Mean)
Placebo	62
BAI 320 mcg/Day	205
BAI 640 mcg/Day	212
MDI 320 mcg/Day	210

Participants With Treatment-Emergent Adverse Events (TEAE)

An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly/birth defect, or an important medical event that may not result in death, be life-threatening, or require hospitalization, but may jeopardize the patient and may require medical intervention to prevent one of the outcomes listed in this definition. (NCT02513160)
Timeframe: Day 0 to Week 6

,,,

Intervention	Participants (Count of Participants)
	>=1 adverse event	>=1 mild TEAE	>=1 moderate TEAE	>=1 severe TEAE	>=1 treatment-related TEAE	>=1 serious TEAE	>=1 AE leading to withdrawal of study drug
BAI 320 mcg/Day	22	10	11	1	2	0	1
BAI 640 mcg/Day	32	18	10	4	9	2	1
MDI 320 mcg/Day	32	20	11	1	4	0	0
Placebo	20	10	9	1	1	0	0

Change From Baseline in Weekly Average of Daily Evening Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period

"A hand-held peak flow meter was provided to patients at the screening visit and used to determine the morning and evening PEF throughout the course of the study. The patient recorded the highest value of 3 measurements obtained in the morning and evening in the patient diary.~Baseline in evening PEF is defined as the average of recorded evening PEF assessments over the 7-day window before randomization.~The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction." (NCT02040779)
Timeframe: Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Intervention	L/minute (Least Squares Mean)
Placebo BAI	-0.797
BDP 80 mcg BAI	10.105
BDP 160 mcg BAI	4.608

Change From Baseline in Weekly Average of Daily Trough Morning Peak Expiratory Flow (PEF) Rate Over the 12-Week Treatment Period

"Change from baseline in the weekly average of daily trough morning (pre-dose and pre-rescue bronchodilator) PEF by handheld spirometer over the 12-week treatment period.~PEF were determined twice daily, in the morning and in the evening, before administration of study drug or rescue medications. A handheld spirometer was provided to patients and used to determine the morning and evening PEF throughout the study. The spirometer was programmed to record the highest PEF obtained from 3 valid attempts.~Baseline was defined as the average of recorded trough morning PEF assessments over the 7 days prior to the first dose of double-blind study treatment, including the morning assessment at the randomization visit.~The LS means, difference of LS means and its 95% confidence interval, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week, and treatment by week interaction." (NCT02040779)
Timeframe: Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Intervention	L/minute (Least Squares Mean)
Placebo BAI	-0.795
BDP 80 mcg BAI	12.849
BDP 160 mcg BAI	7.116

Change From Baseline in Weekly Average of Total Daily Asthma Symptom Score Over the 12-Week Treatment Period

"Asthma symptom scores were recorded in the patient's diary each morning and evening before determining FEV1 and PEF and before administration of study or rescue medications.~The Daytime Symptom Score was recorded in the evening on a scale of 0 (No symptoms during the day) to 5 (Symptoms so severe that I could not go to work or perform normal daily activities) plus the Nighttime Symptom Score in the morning on a scale of 0 (No symptoms during the night) to 4 (Symptoms so severe that I did not sleep at all) for a total score range of 0-9.~Baseline was defined as the average of recorded daily asthma symptom scores (average of daytime and nighttime score) over the 7 days prior to the first dose of study treatment, including the morning assessment at the randomization visit.~The LS means, difference of LS means and its 95% CI, and p value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy," (NCT02040779)
Timeframe: Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Intervention	units on a scale (Least Squares Mean)
Placebo BAI	-0.166
BDP 80 mcg BAI	-0.293
BDP 160 mcg BAI	-0.304

Change From Baseline in Weekly Average of Total Daily Use of Albuterol/Salbutamol Inhalation Aerosol Over Weeks 1-12

"Change from baseline in the use of rescue medication, albuterol/salbutamol, during the treatment period offers an indication of asthma control.~The LS means, difference of LS means and its 95% CI, and p-value are obtained from the mixed model for repeated measures analysis with covariate adjustment for baseline, sex, age, current asthma therapy, treatment, week and treatment by week interaction.~Baseline was defined as the average of recorded daily usage of albuterol/salbutamol inhalation aerosol over the 7 days prior to the first dose of double-blind study treatment, including morning usage at the randomization visit." (NCT02040779)
Timeframe: Baseline (Days -6 to Day 1 pre-dose), daily up to Week 12

Intervention	inhalations (Least Squares Mean)
Placebo BAI	-0.010
BDP 80 mcg BAI	-0.368
BDP 160 mcg BAI	-0.398

Kaplan-Meier Estimates of Time to Study Drug Treatment Withdrawal Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

"The time to patient study drug treatment withdrawal due to worsening asthma was defined as the number of days elapsed from the date of randomization to the date of withdrawal due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.~An example of alert criteria is:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).~Other criteria as defined in the protocol." (NCT02040779)
Timeframe: Treatment period: daily from Day 1 up to Week 12

Intervention	days (Median)
Placebo BAI	NA
BDP 80 mcg BAI	NA
BDP 160 mcg BAI	NA

Number of Participants Withdrawn From Study Due to Meeting Stopping Criteria for Worsening Asthma During the 12-Week Treatment Period

"A count of participants who were withdrawn from the study due to meeting stopping criteria. Alert criteria for individual patients with worsening asthma were designed to ensure patient safety. The investigator determined whether the patient's overall clinical picture is consistent with worsening asthma and if the patient should be withdrawn from study drug treatment (but not the study) and be placed on appropriate asthma therapy in the interest of patient safety.~An example of alert criteria is:~FEV1 as measured at the study center is below the FEV1 stability limit value calculated at randomization visit (Day 1).~Other criteria as defined in the protocol." (NCT02040779)
Timeframe: Treatment period: Day 1 up to Week 12

Intervention	Participants (Count of Participants)
Placebo BAI	5
BDP 80 mcg BAI	2
BDP 160 mcg BAI	0

Standardized Baseline-Adjusted Trough Morning Forced Expiratory Volume in One Minute (FEV1) Area Under the Effect Curve From Time Zero to 12 Weeks (AUEC(0-12wk)) by Actual Treatment Received

"The primary efficacy variable was the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) FEV1 AUEC(0-12wk). Pulmonary function measurements such as FEV1 were obtained electronically by spirometry at the randomization visit (Day 1), each treatment visit (Weeks 2, 4, 8 and 12) and any unscheduled visit (such as the early termination visit). This summary is based on observed values recorded as 'best attempt'.~The least-square (LS) means, difference of LS means and its 95% confidence interval (CI), and p-value represent the results obtained from the analysis of covariance with covariate adjustment for baseline, sex, age, current asthma therapy, and treatment." (NCT02040779)
Timeframe: Baseline (Day 1 predose), weeks 2, 4, 8 and 12

Intervention	liters (Least Squares Mean)
Placebo BAI	0.048
BDP 80 mcg BAI	0.171
BDP 160 mcg BAI	0.164

Participants With Findings During Oropharyngeal Examination During Treatment

Oropharyngeal examinations were performed at every visit by a qualified healthcare professional: during treatment visits are summarized. Any visual evidence of oral candidiasis during the treatment period of the study was evaluated by obtaining and analyzing a swab of the suspect area for culturing. Appropriate therapy was to be initiated immediately at the discretion of the investigator and was not to be delayed for culture confirmation. (NCT02040779)
Timeframe: Visits at weeks 2, 4, 8, 12

Intervention	Participants (Count of Participants)
	>=1 evidence of oral candidiasis appearance	Participants with a positive culture
BDP 160 mcg BAI	2	1
BDP 80 mcg BAI	0	0
Placebo BAI	0	0

Participants With Potentially Clinically Relevant Abnormal Vital Sign Results During the Treatment Period

"Criteria for the select vital signs that showed a potentially clinically relevant abnormal result are:~Sitting systolic BP (low); <=90 mm Hg and decrease of >=20 mm Hg from baseline~Sitting diastolic BP (high): >=105 mm Hg and increase of >=15 mm Hg from baseline~Baseline is defined as the last available assessment prior to the first dose of double-blind study treatment (usually Day 1 predose)." (NCT02040779)
Timeframe: Baseline (Day 1 predose), Visits at weeks 2, 4, 8, 12

Intervention	Participants (Count of Participants)
	>=1 abnormality	Sitting systolic BP (low)	Sitting diastolic BP (high)
BDP 160 mcg BAI	2	1	1
BDP 80 mcg BAI	2	1	1
Placebo BAI	2	1	1

Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent 1 of the outcomes listed in this definition. (NCT02040779)
Timeframe: Day 1 up to Week 12

Intervention	Participants (Count of Participants)
	>=1 adverse event	>=1 severe TEAE	>=1 treatment-related TEAE	>=1 serious TEAE	>=1 AE causing discontinuation
BDP 160 mcg BAI	26	0	2	0	0
BDP 80 mcg BAI	32	0	1	0	0
Placebo BAI	28	2	1	1	1

Change From Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12

"Trough FEV1 was a morning spirometry taken predose and pre-rescue bronchodilator. If the patient inadvertently administered asthma medication/study drug at home on the AM of the visit, or if the patient took rescue medication within 6 hours of testing, the visit was rescheduled.~The baseline for predose FEV1 was defined as the average of the 30-minute and 10-minute predose measurements obtained at the randomization visit (Day 1)." (NCT02139644)
Timeframe: Day 1 (predose, baseline), Week 12

Intervention	liters (Least Squares Mean)
FS MDPI 100 / 12.5 mcg	0.315
FS MDPI 50 / 12.5 mcg	0.319
Fp MDPI 100 mcg	0.204
Fp MDPI 50 mcg	0.172
Placebo MDPI	0.053

Change From Baseline in the Asthma Quality of Life Questionnaire With Standardized Activities (AQLQ(S)) Score at Endpoint for Patients >=18 Years Old

"The AQLQ(S) (September 2010 version; patients aged ≥18 years) was self-administered by the patients at the investigational center at the randomization visit and at Week 12 or end of trial. The questionnaire is a tool to measure the impact of asthma on a patient's quality of life (physical, emotional, social, and occupational) with a recall period of 2 weeks. The AQLQ(S) was administered only to patients 18 years and older. The 32 individual questions in the AQLQ were equally weighted. The overall AQLQ score was the mean of the responses to each of the 32 questions, and ranged from 1 to 7. A score of 7.0 indicated that the patient had no impairments due to asthma and a score of 1.0 indicated severe impairment.~Positive change from baseline scores indicate improved quality of life." (NCT02139644)
Timeframe: Day 1 (predose, baseline), end of trial (up to week 12)

Intervention	units on a scale (Least Squares Mean)
FS MDPI 100 / 12.5 mcg	0.808
FS MDPI 50 / 12.5 mcg	0.565
Fp MDPI 100 mcg	0.636
Fp MDPI 50 mcg	0.588
Placebo MDPI	0.335

Change From Baseline in the Weekly Average of the Daily Morning Trough Peak Expiratory Flow (PEF) Over the 12 Week Treatment

Morning PEF tests were performed before administration of study drug or rescue medications (data were excluded if the time of PEF measurement was more than 5 minutes after the dose time). The patient recorded the highest value of 3 measurements obtained in the patient diary. The baseline PEF was the average value of recorded (nonmissing) morning assessments over the 7 days prior to randomization on Day 1. For efficacy analyses of weekly average morning PEF measurements, values were the averages based on available data for that week. (NCT02139644)
Timeframe: Days -6 to Day 1 (predose), Day 1 (postdose) daily until Week 12

Intervention	liters/minute (Least Squares Mean)
FS MDPI 100 / 12.5 mcg	24.415
FS MDPI 50 / 12.5 mcg	24.864
Fp MDPI 100 mcg	14.517
Fp MDPI 50 mcg	10.609
Placebo MDPI	3.591

Change From Baseline in the Weekly Average of the Total Daily (24-hour) Use of Albuterol/Salbutamol Inhalation Aerosol Over the 12-Week Treatment Period

Patients recorded the number of inhalations of rescue medication (albuterol/salbutamol HFA MDI) each AM and PM in the diary. The average number of daily inhalations over the 7 days before the randomization visit was the baseline value. The weekly average was based on the available data for the 7 days before each analysis week. The change from baseline in the weekly average of total daily (24-hour) use of albuterol/ salbutamol inhalation aerosol (number of inhalations) over weeks 1 to 12 was analyzed using a mixed model for repeated measures. (NCT02139644)
Timeframe: Days -6 to Day 1 (predose, baseline), up to week 12

Intervention	puffs (Least Squares Mean)
FS MDPI 100 / 12.5 mcg	-0.677
FS MDPI 50 / 12.5 mcg	-0.706
Fp MDPI 100 mcg	-0.466
Fp MDPI 50 mcg	-0.467
Placebo MDPI	-0.003

Change From Baseline in the Weekly Average of the Total Daily Asthma Symptom Score Over the 12-Week Treatment Period

"The total daily asthma symptom score is the average of the daytime and nighttime scores as recorded in the patient diary (range 0-9).~Daytime Symptom Score:~0=No symptoms~Symptoms for 1 short period~Symptoms for 2+ short periods~Symptoms for most of the day - did not affect normal daily activities~Symptoms for most of the day - did affect normal daily activities~Symptoms so severe that I could not go to work or perform normal daily activities~Nighttime Symptom Score (determined in the AM):~0=No symptoms~Symptoms causing me to wake once (or wake early)~Symptoms causing me to wake twice or more (including waking early)~Symptoms causing me to be awake for most of the night~Symptoms so severe that I did not sleep Baseline was the average of recorded scores over the 7 days before randomization. The change from baseline in the weekly average over weeks 1 to 12 was analyzed using an mixed model for repeated measures (MMRM)." (NCT02139644)
Timeframe: Days -6 to Day 1 (predose, baseline) to Week 12

Intervention	units on a scale (Least Squares Mean)
FS MDPI 100 / 12.5 mcg	-0.364
FS MDPI 50 / 12.5 mcg	-0.329
Fp MDPI 100 mcg	-0.300
Fp MDPI 50 mcg	-0.278
Placebo MDPI	-0.135

Kaplan-Meier Estimate of Probability of Remaining in Study At Week 12

The analysis of probability of remaining in the study at Week 12 used the time to patient withdrawal for worsening asthma, defined as the number of days elapsed from the date of randomization to the date of withdrawal due to worsening asthma. Patients who were lost to follow-up, who had not withdrawn due to worsening asthma by week 12, or who had withdrawn due to reasons other than worsening asthma were right-censored at the date of last assessment. (NCT02139644)
Timeframe: up to Week 12 of the Treatment Period

Intervention	probability (Number)
FS MDPI 100 / 12.5 mcg	1.0000
FS MDPI 50 / 12.5 mcg	0.9917
Fp MDPI 100 mcg	0.9919
Fp MDPI 50 mcg	0.9919
Placebo MDPI	0.9681

Standardized Baseline-Adjusted Forced Expiratory Volume in 1 Second (FEV1) Area Under the Effect Curve From Time Zero to 12 Hours Postdose (FEV1 AUEC0-12h) at Week 12

"A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Data from these assessments were used to analyze the primary endpoint of baseline adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement.~The baseline FEV1 was the average of the 2 predose FEV1 measurements (30 and 10 minutes predose). If 1 of these was missing, the nonmissing value was used; if both were missing, baseline was treated as missing. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting the baseline FEV1 value." (NCT02139644)
Timeframe: Day 1 (predose, baseline), Week 12 and was performed at the following times relative to the administration of study drug (±5 minutes): 15 and 30 minutes and 1, 2, 3, 4, 6, 8, 10, and 12 hours

Intervention	liters (Least Squares Mean)
FS MDPI 100 / 12.5 mcg	0.408
FS MDPI 50 / 12.5 mcg	0.399
Fp MDPI 100 mcg	0.254
Fp MDPI 50 mcg	0.268
Placebo MDPI	0.074

Kaplan-Meier Estimates for Time to 15% and 12% Improvement From Baseline in FEV1 Postdose on Day 1

"A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Baseline FEV1 was the average of 2 FEV1 measurements (30 and 10 minutes predose) on Day 1. If one of these was missing, the other measurement was used as baseline value. If both were missing, baseline was treated as missing. Time to target improvement (15% or 12%) was defined as the time elapsed from the time of first dose to the first time the target improvement in FEV1 was achieved. If an exact target increase was not achieved at a measured timepoint, then the time was estimated by linear interpolation between the timepoint when target was reached and the timepoint immediately before. Patients who did not achieve the target improvement were censored at the time of last serial spirometry assessment.~Values of 9999 indicate the values could not be estimated which happened when the estimated probability of not achieving target is more than 50%." (NCT02139644)
Timeframe: Day 1 of the Treatment Period (predose and postdose)

,,,,

Intervention	hours (Median)
	15% improvement	12% improvement
Fp MDPI 100 mcg	NA	NA
Fp MDPI 50 mcg	NA	NA
FS MDPI 100 / 12.5 mcg	4.3	1.0
FS MDPI 50 / 12.5 mcg	1.3	0.5
Placebo MDPI	NA	NA

Patients With Treatment-Emergent Adverse Experiences (TEAE) During the Treatment Period

An adverse event was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relationship of AE to treatment was determined by the investigator. Serious AEs include death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, OR an important medical event that jeopardized the patient and required medical intervention to prevent the previously listed serious outcomes. (NCT02139644)
Timeframe: Day 1 to Week 12 of the Treatment Period

,,,,

Intervention	Participants (Count of Participants)
	>=1 TEAE	>=1 severe TEAE	>=1 treatment-related TEAE	>=1 severe treatment-related TEAE	>=1 serious TEAE	>=1 TEAE leading to withdrawal	>=1 nonserious TEAE	>=1 TEAE resulting in death
Fp MDPI 100 mcg	40	1	5	0	1	2	39	0
Fp MDPI 50 mcg	44	1	7	0	0	1	44	0
FS MDPI 100 / 12.5 mcg	37	2	4	0	1	0	36	0
FS MDPI 50 / 12.5 mcg	46	0	4	0	0	3	46	0
Placebo MDPI	47	0	5	0	2	6	45	0

Acute Rejection

(NCT02351180)
Timeframe: 180 days

Intervention	Participants (Count of Participants)
Inhaled Beclomethasone	1
Placebo	0

Chronic Lung Allograft Dysfunction

(NCT02351180)
Timeframe: 180 days

Intervention	Participants (Count of Participants)
Inhaled Beclomethasone	2
Placebo	3

Death

(NCT02351180)
Timeframe: 180 days

Intervention	Participants (Count of Participants)
Inhaled Beclomethasone	0
Placebo	0

Donor-specific Antibodies

(NCT02351180)
Timeframe: 180 days

Intervention	Participants (Count of Participants)
Inhaled Beclomethasone	0
Placebo	0

Lymphocytic Bronchiolitis

(NCT02351180)
Timeframe: 180 days

Intervention	Participants (Count of Participants)
Inhaled Beclomethasone	0
Placebo	1

Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction

(NCT02351180)
Timeframe: 180 days

Intervention	Participants (Count of Participants)
Inhaled Beclomethasone	2
Placebo	4

Gastrointestinal (GI) Graft-vs-Host Disease (GVHD) Symptoms

"Patients who achieved a Complete Response (CR) of their GI GVHD Symptoms during the Part 1, 16 week treatment period and who remained a CR at the end of the 16 week treatment period were to be eligible to continue into Part 2 of the study. All others were to discontinue.~GI GVHD was assessed using a composite score based on the symptoms of satiety, nausea/vomiting, and anorexia. Each symptom was scored on a scale of 0-3, such that the minimum score = 0 and the maximum score = 9. At entry, all subjects must have a score of ≥ 3. A CR will be defined as a composite score of 0." (NCT01925950)
Timeframe: 16 weeks

Intervention	Participants (Count of Participants)
Placebo	1
orBec	0

Area Under the Concentration-time Curve From Time Zero to 24 Hours (AUC0-24) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)

Beclomethasone-17-monopropionate (17-BMP) is the active metabolite of BDP. Plasma concentrations of 17-BMP or BDP that were below the lower-limit-of-quantitation (LLOQ), 20 or 10 pg/mL, respectively, were assigned a zero value when calculating descriptive statistics. (NCT01697956)
Timeframe: Day 42 (Predose (within 30 minutes prior to dose administration) and at 0.25 (15 min), 0.5 (30 min), 1, 1.5, 3, 6, 12, and 24 hours after final study medication administration)

Intervention	h*pg/mL (Mean)
17-BMP Pharmacokinetic Parameters	619.06
BDP Pharmacokinetic Parameters	200.80

Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration (AUC0-t ) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)

Intervention	h*pg/mL (Mean)
17-BMP Pharmacokinetic Parameters	573.81
BDP Pharmacokinetic Parameters	45.60

Change From Baseline (Expressed As A Ratio) In 24-Hr Serum Cortisol Weighted Mean Following 6 Weeks Of Treatment

The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived. (NCT01697956)
Timeframe: Baseline (Day 1, -24, -22, -20, -16, -12, -8, and 0 hours prior to study medication), End of Treatment (Day 43, (Immediately prior to study medication administration (Hour 0) and at 2, 4, 8, 12, 16, and 24 hours after study medication administration)

Intervention	ratio (Geometric Mean)
BDP Nasal Aerosol 80 mcg/Day	1.04
Placebo Nasal Aerosol	1.10

Maximum Plasma Concentration (Cmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)

Intervention	pg/mL (Mean)
17-BMP Pharmacokinetic Parameters	142.68
BDP Pharmacokinetic Parameters	44.65

Terminal Elimination Half-life (t1/2) for Beclomethasone-17-monopropionate (17-BMP)

Intervention	hours (Mean)
17-BMP Pharmacokinetic Parameters	3.10

Terminal Elimination Rate Constant (λz ) for Beclomethasone-17-monopropionate (17-BMP)

Intervention	1/hour (Mean)
17-BMP Pharmacokinetic Parameters	0.31

Time to Reach Maximum Plasma Concentration (Tmax) for Beclomethasone-17-monopropionate (17-BMP) and Beclomethasone Dipropionate (BDP)

Intervention	hours (Mean)
17-BMP Pharmacokinetic Parameters	1.15
BDP Pharmacokinetic Parameters	1.26

Participants With Shifts in Hematology Results From Normal at Screening to High or Low at End of Study

"Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.~MCHC = mean corpuscular hemoglobin concentration MCV = mean corpuscular volume, or mean cell volume MCH = mean corpuscular hemoglobin or mean cell hemoglobin" (NCT01697956)
Timeframe: Screening (Day -21 to -7), End of Study (Day 42)

,,,

Intervention	participants (Number)
	Hemaglobin (g/L)	Hematocrit (l/l)	MCHC (g/L)	MCV (FL)	MCH (pg)	Red blood cells (10^12/L)	Platelets (10^9/L)	White blood cells (10^9/L)	Basophils (10^9/L)	Eosinsphils (10^9/L)	Lymphocytes (10^9/L)	Monocytes (10^9/L)	Neutrophils (10^9/L)	Segmented neutrophils (10^9/L)
BDP Nasal Aerosol 80 mcg/Day - Shift to High	0	0	0	0	0	0	0	0	0	2	0	0	0	0
BDP Nasal Aerosol 80 mcg/Day - Shift to Low	1	4	0	0	0	3	1	9	0	8	1	10	8	8
Placebo Nasal Aerosol - Shift to High	0	1	0	0	0	0	0	0	0	3	0	0	0	0
Placebo Nasal Aerosol - Shift to Low	0	2	0	0	0	2	0	2	0	2	1	5	4	4

Participants With Shifts in Serum Chemistry Results From Normal at Screening to High or Low at End of Study

"Shifting to 'High' refers to starting the study within normal range and being outside the high-end of normal by end of study. Conversely, shifting to 'Low' refers to starting the study within normal range and being outside the low-end of normal by end of study.~BUN = blood urea nitrogen AST = aspartate transaminase ALT = alanine transaminase GGT = gamma-glutamyl transpeptidase" (NCT01697956)
Timeframe: Screening (Day -21 to -7), End of Study (Day 42)

,,,

Intervention	participants (Number)
	Sodium (mmol/L)	Potassium (mmol/L)	Chloride (mmol/L)	Bicarbonate (mmol/L)	Glucose (mmol/L)	BUN (mmol/L)	Creatinine (micromol/L)	Calcium (mmol/L)	Phosphorus (mmol/L)	Total protein (g/L)	Albumin (g/L)	Uric acid (micromol/L)	AST (u/L)	ALT (u/L)	Alkaline phosphatase (u/L)	GGT (u/L)	Total bilirubin (micromol/L)	Lactate dehydrogenase (u/L)
BDP Nasal Aerosol 80 mcg/Day - Shift to High	0	0	2	0	1	0	0	1	0	0	0	0	1	0	0	0	0	1
BDP Nasal Aerosol 80 mcg/Day - Shift to Low	0	0	0	8	1	0	0	0	0	0	0	1	0	0	0	0	0	0
Placebo Nasal Aerosol - Shift to High	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Placebo Nasal Aerosol - Shift to Low	0	0	0	3	2	0	1	0	0	0	0	0	0	0	0	0	0	0

Participants With Treatment-Emergent Adverse Events (AEs)

"The intensity or severity of the AE was characterized as mild (AE which is easily tolerated), moderate (AE sufficiently discomforting to interfere with daily activity) or severe (AE which prevents normal daily activities).~The causal relationship was characterized as not related (no reasonable possibility that the AE was caused by or attributed to the investigational product) or related reasonable possibility that the AE was caused by or attributed to the investigational product / a causal relationship cannot be ruled out).~An SAE was defined as an AE that resulted in any of the following:~Death~Life-threatening~Required hospitalization or prolonged existing hospitalization~Persistent or significant disability or incapacity~A congenital abnormality or birth defect~An important medical event which required medical intervention to prevent any of the above outcomes." (NCT01697956)
Timeframe: Day 1- week 10

Intervention	participants (Number)
	>=1 AEs	Withdrawn due to AEs	Severe AEs	Treatment-related AEs	>=1 SAEs
BDP Nasal Aerosol 80 mcg/Day	22	0	2	2	0
Placebo Nasal Aerosol	13	0	1	1	0

Condition	Relationship Strength	Studies
Acute Liver Injury, Drug-Induced	low	4
Adverse Drug Event	low	3
Adverse Drug Reaction	low	3
Benign Neoplasms	low	1
Cancer	low	1
Chemical and Drug Induced Liver Injury	low	4
Chemically-Induced Liver Toxicity	low	4
Congenital Zika Syndrome	low	1
Congenital Zika Virus Infection	low	1
Cystic Fibrosis	low	1
Cystic Fibrosis of Pancreas	low	1
Disease Models, Animal	low	1
Drug Side Effects	low	3
Drug Toxicity	low	3
Drug-Induced Acute Liver Injury	low	4
Drug-Induced Liver Disease	low	4
Drug-Induced Liver Injury	low	4
Drug-Related Side Effects and Adverse Reactions	low	3
Fever, Zika	low	1
Fibrocystic Disease of Pancreas	low	1
Hepatitis, Drug-Induced	low	4
Hepatitis, Toxic	low	4
Inflammation	low	1
Innate Inflammatory Response	low	1
Liver Injury, Drug-Induced	low	4
Liver Injury, Drug-Induced, Acute	low	4
Malignancy	low	1
Malignant Neoplasms	low	1
Mucoviscidosis	low	1
Neoplasia	low	1
Neoplasm	low	1
Neoplasms	low	1
Neoplasms, Benign	low	1
Pancreatic Cystic Fibrosis	low	1
Parasite Infections	low	1
Parasitic Diseases	low	1
Parasitic Infections	low	1
Pulmonary Cystic Fibrosis	low	1
Sensitivity and Specificity	low	1
Side Effects of Drugs	low	3
Toxic Hepatitis	low	4
Toxicity, Drug	low	3
Tumors	low	1
Zika Fever	low	1
Zika Virus Disease	low	1
Zika Virus Infection	low	1
ZikV Infection	low	1

beclomethasone

Cross-References

Synonyms (77)

Roles (2)

Drug Classes (10)

Protein Targets (45)

Potency Measurements

Inhibition Measurements

Biological Processes (115)

Molecular Functions (49)

Ceullar Components (40)

Bioassays (149)

Research

Studies (24)

Study Types

Clinical Trials (144)

Trial Overview

Trial Outcomes

Mean rTNSS Over Period

Correlation of EARNS-Q Preference Module With EARNS-Q Experience Module Change Scores

Correlations of Experience With Allergic Rhinitis Nasal Sprays Questionnaire (EARNS-Q) Preference Module With Treatment Satisfaction Questionnaire for Medicines (TSQM) Change Scores and Change in Mean Daily Reflective Total Nasal Symptom (rTNSS) Scores

Adherence of Asthma Controller Medication

Asthma Control Test (ACT)

Change in Composite Asthma Severity Index (CASI)

Pulmonary Function Measured by Spirometry: Forced Expiratory Volume in 1 Second (FEV1) / Forced Vital Capacity (FVC)

Mean Change From Baseline in Daytime Symptom Score on the Daytime Asthma Symptoms Diary in Patients With Chronic Asthma

Mean Change From Baseline in Morning Peak Flow Rate (PEFR) in Patients With Chronic Asthma

Mean Change From Baseline in Nocturnal Asthma Score on the Overnight Asthma Symptoms Diary in Nocturnal Asthmatic Patients Only

Mean Percent Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) in Patients With Chronic Asthma

Mean Percent Change From Baseline in Total Daily Beta-agonist Medication Use

Change From Baseline at Week 2 in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) in Participants With Impaired Quality of Life at Baseline

Change From Baseline in AM and PM Subject-reported Reflective Ocular Symptom Score Over the 2-week Treatment Period

Change From Baseline in Average Subject-Reported AM and PM Instantaneous Total Nasal Symptom Score (iTNSS) Over the Two-week Treatment Period

Change From Baseline in Average Subject-Reported AM and PM Reflective Total Nasal Symptom Score (rTNSS) Over the Two-week Treatment Period

12-lead ECG Parameters - Heart Rate - Change From Baseline

24-hr Creatinine - Change From Baseline.

24-hr Urine Free Cortisol - Change From Baseline

Pre-dose Morning FEV1 at Week 4 - Change From Baseline

Pre-dose Morning FEV1 at Week 8 - Change From Baseline

12-lead ECG Parameters - PR, QRS, QTcF - Change From Baseline.

12-lead ECG Parameters - Prolonged QTcF - Change From Baseline

Asthma Control Questionnaire-7© (ACQ-7) Score at Week 4 and Week 8 - Change From Baseline

Average Use of Rescue Medication - Change From Baseline

Overall Daily Asthma Symptoms Scores - Change From Baseline

Percentage (%) of Asthma Control Days - Change From Baseline

Percentage (%) of Asthma Symptoms-free Days - Change From Baseline

Percentage (%) of Rescue Medication-free Days - Change From Baseline

Pre-dose Morning FVC at Week 4 and 8 - Change From Baseline

Pre-dose Peak Expiratory Flow (PEF) (L/Min) (Morning and Evening) - Change From Baseline

Vital Signs (Systolic and Diastolic Blood Pressure) - Change From Baseline

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Instantaneous Total Nasal Symptom Score (iTNSS) During the Two Weeks of Treatment

Change From Baseline in the Average Morning (AM) and Evening (PM) Subject-Reported Reflective Total Nasal Symptom Score (rTNSS) During the Two Weeks of Treatment

Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE)

Number of Participants Who Experienced ≥1 Adverse Event

Response To Therapy At Day 15 (Participant-Evaluated)

Response To Therapy At Day 15 (Physician-Evaluated)

Response To Therapy At Day 22 (Participant-Evaluated)

Response To Therapy At Day 22 (Physician-Evaluated)

Response To Therapy At Day 29 (Participant-Evaluated)

Response To Therapy At Day 29 (Physician-Evaluated)

Response To Therapy At Day 4 (Participant-Evaluated)

Response To Therapy At Day 4 (Physician-Evaluated)

Response To Therapy At Day 8 (Participant-Evaluated)

Response To Therapy At Day 8 (Physician-Evaluated)

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated)

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated)

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated)

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated)

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated)

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated)

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated)

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated)

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated)

Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated)

Change From Baseline in the TNSS At Day 15 (Physician-Evaluated)

Change From Baseline in the TNSS At Day 22 (Physician-Evaluated)

Change From Baseline in the TNSS At Day 29 (Physician-Evaluated)

Change From Baseline in the TNSS At Day 4 (Physician-Evaluated)

Change From Baseline in the TNSS At Day 8 (Physician-Evaluated)

Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated)