Page last updated: 2024-10-16

bromide and Asthma

bromide has been researched along with Asthma in 10 studies

Bromides: Salts of hydrobromic acid, HBr, with the bromine atom in the 1- oxidation state. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed)

Asthma: A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Research

Studies (10)

TimeframeStudies, this research(%)All Research%
pre-19908 (80.00)18.7374
1990's1 (10.00)18.2507
2000's0 (0.00)29.6817
2010's0 (0.00)24.3611
2020's1 (10.00)2.80

Authors

AuthorsStudies
Yang, S1
Lee, LA1
Sule, N1
Fowler, A1
Peachey, G1
OLIVIER, HR1
DIOGUARDI, N1
SECCHI, GC1
GUERTLER, J1
Motojima, S1
Adachi, T1
Manaka, K1
Arima, M1
Fukuda, T1
Makino, S1
Gyurkovits, K1
Markus, V1
Bittera, I1
Creeth, JM1
Bhaskar, KR1
Horton, JR1
Das, I1
Lopez-Vidriero, MT1
Reid, L1
Nana, A1
Cardan, E1
Leitersdorfer, T1
Levin, N1
Dillon, JB1
Jacobi, H1
Renneberg, KH1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase III, Randomized, Double-blind, Active Controlled, Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Combination FF/UMEC/VI With the Fixed Dose Dual Combination of FF/VI, Administered Once-daily Via a Dry Powde[NCT02924688]Phase 32,436 participants (Actual)Interventional2016-10-13Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Annualized Rate of Moderate and Severe Asthma Exacerbations

A moderate asthma exacerbation is considered to be a deterioration in asthma symptoms or in lung function, or increased rescue bronchodilator use lasting for at least 2 days or more, but not be severe enough to warrant systemic corticosteroid use (or a doubling or more of the maintenance systemic corticosteroid dose, if applicable) for 3 days or more and/or hospitalization. It is an event that, when recognized, should result in a temporary change in treatment, to prevent it from becoming severe. A severe asthma exacerbation is defined as the deterioration of asthma requiring the use of systemic corticosteroids (tablets,suspension or injection), or an increase from a stable maintenance dose (For participants receiving maintenance systemic corticosteroids, at least double the maintenance systemic corticosteroid dose for at least 3 days is required), for at least 3 days or an inpatient hospitalization or emergency department visit because of asthma, requiring systemic corticosteroids. (NCT02924688)
Timeframe: Up to Week 52

InterventionExacerbations per year (Mean)
FF/VI0.70
FF/UMEC/VI (UMEC 31.25 mcg)0.68
FF/UMEC/VI (UMEC 62.5 mcg)0.61

Mean Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 24

The ACQ-7 consists of 7 attributes of asthma control, of which 6 to be self-completed by participant in a 6-item questionnaire, enquire about frequency and/or severity of symptoms over the previous week on: nocturnal awakening, symptoms on waking in the morning, activity limitation, shortness of breath, wheeze, and rescue medication use. The seventh attribute measures the lung function, which was included via pre-bronchodilator FEV1 % predicted value. All 7 items of ACQ have response on 0-6 ordinal scale (0=no impairment/limitation, 6=total impairment/limitation). The total score is calculated as the average of all non-missing item responses, ranges from 0 to 6. Higher score indicates worst symptoms. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was at randomization visit (pre-dose,Day 1). Change from Baseline was defined as value at Week 24 minus Baseline value. (NCT02924688)
Timeframe: Baseline (pre-dose at Day 1) and Week 24

InterventionScores on a scale (Least Squares Mean)
FF/VI-0.678
FF/UMEC/VI (UMEC 31.25 mcg)-0.734
FF/UMEC/VI (UMEC 62.5 mcg)-0.767

Mean Change From Baseline in Clinic FEV1 at 3 Hours Post Study Treatment at Week 24

FEV1 is a measure of lung function and is defined as the maximal volume of air that can be forcefully exhaled in one second. Baseline value is the last acceptable/borderline acceptable pre-dose FEV1 prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at Week 24 (recorded at 3 hours post dose) minus the Baseline value. (NCT02924688)
Timeframe: Baseline (pre-dose at Day 1) and 3 hours post dose at Week 24

InterventionLiters (Least Squares Mean)
FF/VI 100/25 mcg0.132
FF/UMEC/VI 100/ 31.25/25 mcg0.220
FF/UMEC/VI 100/62.5/25 mcg0.243
FF/VI 200/25 mcg0.168
FF/UMEC/VI 200/ 31.25/25 mcg0.256
FF/UMEC/VI 200/62.5/25 mcg0.286

Mean Change From Baseline in Evaluating Respiratory Symptoms (E-RS) Total Score Over Weeks 21 to 24 (Inclusive) of the Treatment Period

The E-RS in Chronic Obstructive Pulmonary Disease (COPD) consists of 11 items. E-RS captures information related to respiratory symptoms, i.e. breathlessness, cough, sputum production, chest congestion and chest tightness. The E-RS was completed daily and data was derived by 4-weekly intervals, requiring at least 50% of data to be present during a period. 7 items are scored from 0 (not at all) to 4 (extreme) and 4 items are scored from 0 (not at all) to 3 (extreme). The E-RS total score was calculated by taking sum of all the items. The E-RS total score has a scoring range of 0 to 40, with higher scores indicating more severe respiratory symptoms. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was the mean value of 14 days prior to randomization. Change from Baseline was calculated as post-baseline value (mean of daily E-RS total scores during Week 21 to 24 ) minus Baseline value. (NCT02924688)
Timeframe: Baseline (14 days prior to randomization) and Weeks 21 to 24

InterventionScores on a scale (Least Squares Mean)
FF/VI-2.47
FF/UMEC/VI (UMEC 31.25 mcg)-2.60
FF/UMEC/VI (UMEC 62.5 mcg)-2.89

Mean Change From Baseline in Pulse Rate at Week 24

Pulse Rate was measured in the sitting position after approximately 5 minutes rest. Baseline value is the last acceptable/borderline acceptable value prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at the clinic visit minus the Baseline value. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement. (NCT02924688)
Timeframe: Baseline (pre-dose at Day 1) and Week 24

InterventionBeats per minute (Least Squares Mean)
FF/VI 100/25 mcg-1.1
FF/UMEC/VI 100/ 31.25/25 mcg0.2
FF/UMEC/VI 100/62.5/25 mcg-1.0
FF/VI 200/25 mcg-0.7
FF/UMEC/VI 200/ 31.25/25 mcg-1.3
FF/UMEC/VI 200/62.5/25 mcg-0.5

Mean Change From Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score at Week 24

The SGRQ had 50 questions (scored from 0 to 100 where 0 indicates best and 100 indicates worst health) designed to measure quality of life (QoL) of participants with airway obstruction, measuring symptoms, impact, and activity. The questions are designed to be self-completed by the participant with a recall over the past 3 months. SGRQ total score was calculated by summing the pre-assigned weights of answers, dividing by the sum of the maximum weights for items in SGRQ and multiplying by 100. SGRQ total score ranges from 0 to 100 where 0 indicates best and 100 indicates worst health. A change of 4 points is considered a clinically relevant change. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline value was at randomization visit (pre-dose at Day 1). Change from Baseline value is the value at Week 24 minus the Baseline value. (NCT02924688)
Timeframe: Baseline (pre-dose at Day 1) and Week 24

InterventionScores on a scale (Least Squares Mean)
FF/VI-11.39
FF/UMEC/VI (UMEC 31.25 mcg)-10.29
FF/UMEC/VI (UMEC 62.5 mcg)-11.69

Mean Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 24

FEV1 is a measure of lung function and is defined as the maximal volume of air that can be forcefully exhaled in one second. Trough FEV1 on treatment is defined as the highest FEV1 value obtained prior to the morning dose of investigational product. Baseline value is the last acceptable/borderline acceptable pre-dose FEV1 prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at Week 24 minus the Baseline value. Intent-to-Treat (ITT) Population comprised of all randomized participants, excluding those who were randomized in error, who did not receive the study drug. Treatment policy estimand was assessed, including all on- and post-treatment data. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement. Mixed Model Repeated Measures(MMRM) was used. (NCT02924688)
Timeframe: Baseline (pre-dose at Day 1) and Week 24

InterventionLiters (Least Squares Mean)
FF/VI 100/25 mcg0.024
FF/UMEC/VI 100/ 31.25/25 mcg0.120
FF/UMEC/VI 100/62.5/25 mcg0.134
FF/VI 200/25 mcg0.076
FF/UMEC/VI 200/ 31.25/25 mcg0.157
FF/UMEC/VI 200/62.5/25 mcg0.168

Number of Participants With Abnormal Electrocardiogram (ECG) Findings

Twelve-lead ECGs were performed during the study using an automated ECG machine. All ECG measurements were made with the participant in a supine position having rested in this position for approximately 5 minutes before each reading. The number of participants with worst case post-Baseline abnormal ECG findings were reported. (NCT02924688)
Timeframe: Up to Week 52

InterventionParticipants (Count of Participants)
FF/VI 100/25 mcg115
FF/UMEC/VI 100/ 31.25/25 mcg118
FF/UMEC/VI 100/62.5/25 mcg109
FF/VI 200/25 mcg109
FF/UMEC/VI 200/ 31.25/25 mcg106
FF/UMEC/VI 200/62.5/25 mcg108

Mean Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 24

Blood pressure (systolic and diastolic) was measured in the sitting position after approximately 5 minutes rest. Baseline value is the last acceptable/borderline acceptable value prior to randomized treatment start date (pre-dose at Day 1). Change from Baseline value is the value at the clinic visit minus the Baseline value. Different participants may have been analyzed at different time points; thus, overall number of participants analyzed reflects everyone in ITT Population without missing covariate information, with Baseline and at least one post-baseline measurement. (NCT02924688)
Timeframe: Baseline (pre-dose at Day 1) and Week 24

,,,,,
InterventionMillimeter of mercury (Least Squares Mean)
SBPDBP
FF/UMEC/VI 100/ 31.25/25 mcg0.60.1
FF/UMEC/VI 100/62.5/25 mcg1.11.3
FF/UMEC/VI 200/ 31.25/25 mcg0.80.2
FF/UMEC/VI 200/62.5/25 mcg0.90.8
FF/VI 100/25 mcg1.60.4
FF/VI 200/25 mcg0.20.4

Number of Participants With Abnormal Clinical Chemistry Values

Blood samples were collected for assessment of clinical chemistry parameters, which included albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, total bilirubin, calcium, creatinine, glucose, potassium, protein, sodium and urea. Abnormal laboratory results are categorized as high or low with respect to their normal ranges. Participants having High and Low values from normal ranges for any parameter at any time post-baseline visits are presented. (NCT02924688)
Timeframe: Up to Week 52

,,,,,
InterventionParticipants (Count of Participants)
Albumin, lowAlbumin, highALT, lowALT, highAST, lowAST, highALP, lowALP, highDirect bilirubin, lowDirect bilirubin, highBilirubin, lowBilirubin, highCalcium, lowCalcium, highCreatinine, lowCreatinine, highGlucose, lowGlucose, highPotassium, lowPotassium, highProtein, lowProtein, highSodium, lowSodium, highUrea, lowUrea, high
FF/UMEC/VI 100/ 31.25/25 mcg060290270150101291262711713130177417
FF/UMEC/VI 100/62.5/25 mcg0502401401000057104981170111533753
FF/UMEC/VI 200/ 31.25/25 mcg03027023116020174860912667121375311
FF/UMEC/VI 200/62.5/25 mcg0103001601201013376487736192137113
FF/VI 100/25 mcg2104102912101094454715742153056313
FF/VI 200/25 mcg1202802101202015711636776793254311

Number of Participants With Abnormal Hematology Values

Blood samples were collected for assessment of hematology parameters, which included Basophils, Eosinophils, Lymphocytes, Monocytes, Neutrophils, Erythrocytes, Hematocrit, Hemoglobin, Leukocytes, Platelets, Mean Corpuscular Hemoglobin (MCH) and Mean Corpuscular Volume (MCV). Abnormal laboratory results are categorized as high or low with respect to their normal ranges. Participants having High and Low values from normal ranges for any parameter at any time post-baseline visits are presented. (NCT02924688)
Timeframe: Up to Week 52

,,,,,
InterventionParticipants (Count of Participants)
Basophils, low, n=390,390,391,389,389,396Basophils, high, n=390,390,391,389,389,396Eosinophils, low, n=390,390,391,389,389,396Eosinophils, high, n=390,390,391,389,389,396Lymphocytes, low, n=390,390,391,389,389,396Lymphocytes, high, n=390,390,391,389,389,396Monocytes, low, n=390,390,391,389,389,396Monocytes, high, n=390,390,391,389,389,396Neutrophils, low, n=390,390,391,389,389,396Neutrophils, high, n=390,390,391,389,389,396Erythrocytes, low, n=391,390,392,391,391,397Erythrocytes, high, n=391,390,392,391,391,397Hematocrit, low, n=391,390,392,391,391,397Hematocrit, high, n=391,390,392,391,391,397Hemoglobin, low, n=391,390,392,391,391,397Hemoglobin, high, n=391,390,392,391,391,397Leukocytes, low, n=391,390,391,389,391,396Leukocytes, high, n=391,390,391,389,391,396Platelets, low, n=391,388,389,391,388,396Platelets, high, n=391,388,389,391,388,396MCH, low, n=391,390,392,391,391,397MCH, high, n=391,390,392,391,391,397MCV, low, n=391,390,392,391,391,397MCV, high, n=391,390,392,391,391,397
FF/UMEC/VI 100/ 31.25/25 mcg0027841156811020162128524713122921647322241
FF/UMEC/VI 100/62.5/25 mcg0025102131574161511131650408142031924221025
FF/UMEC/VI 200/ 31.25/25 mcg0032851365171215211720493710122651941251926
FF/UMEC/VI 200/62.5/25 mcg00287810663493422172649341384042125321437
FF/VI 100/25 mcg0126111132607142114242160321493841740182029
FF/VI 200/25 mcg00318487642101915122047401793142134171529

Number of Participants With Any Serious Adverse Event (SAE) and Common (>=3%) Non-SAE

Adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAE and common (>=3%) non-SAEs are presented. (NCT02924688)
Timeframe: Up to Week 52

,,,,,
InterventionParticipants (Count of Participants)
Common non-SAESAE
FF/UMEC/VI 100/ 31.25/25 mcg15018
FF/UMEC/VI 100/62.5/25 mcg13523
FF/UMEC/VI 200/ 31.25/25 mcg12723
FF/UMEC/VI 200/62.5/25 mcg12221
FF/VI 100/25 mcg13625
FF/VI 200/25 mcg12221

Trials

1 trial available for bromide and Asthma

ArticleYear
Population Pharmacokinetic Modeling of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol in Patients with Asthma, Using Data from a Phase IIIA Study (CAPTAIN).
    Clinical pharmacokinetics, 2021, Volume: 60, Issue:7

    Topics: Administration, Inhalation; Androstadienes; Asthma; Benzyl Alcohols; Bromides; Chlorobenzenes; Doubl

2021

Other Studies

9 other studies available for bromide and Asthma

ArticleYear
[Method for the determination of the anti-asthma action of drugs; application to the pharmacological study of lambda-methscopolamine bromide].
    Therapie, 1959, Volume: 14, Issue:1

    Topics: Asthma; Bromides; Humans; N-Methylscopolamine; Research; Scopolamine Derivatives

1959
[Pathogenetic and clinical observations on the use of hyoscine-N-butyl-bromide in asthma attacks].
    Deutsches medizinisches Journal, 1959, Dec-20, Volume: 10

    Topics: Asthma; Bromides; Butylscopolammonium Bromide; Humans; Scopolamine Derivatives

1959
[Experiences with the prolonged-action anti-asthmatic drug: Asmapax (Nicholas)].
    Therapeutische Umschau. Revue therapeutique, 1963, Volume: 20

    Topics: Anti-Asthmatic Agents; Asthma; Bromides; Ephedrine; Humans; Theophylline

1963
Eosinophil peroxidase stimulates the release of granulocyte-macrophage colony-stimulating factor from bronchial epithelial cells.
    The Journal of allergy and clinical immunology, 1996, Volume: 98, Issue:6 Pt 2

    Topics: Asthma; Blotting, Northern; Bromides; Bronchi; Cells, Cultured; Eosinophil Peroxidase; Eosinophils;

1996
Cystic-fibrosis heterozygosity in childhood bronchial asthma.
    Lancet (London, England), 1977, Jan-22, Volume: 1, Issue:8004

    Topics: Asthma; Bromides; Child; Chlorides; Cystic Fibrosis; Heterozygote; Humans; Sodium; Sweat

1977
The separation and characterization of bronchial glycoproteins by density-gradient methods.
    The Biochemical journal, 1977, Dec-01, Volume: 167, Issue:3

    Topics: Amino Acids; Asthma; Bromides; Bronchi; Bronchitis; Centrifugation, Density Gradient; Cesium; Chemic

1977
Pancuronium bromide. Its use in asthmatics and patients with liver disease.
    Anaesthesia, 1972, Volume: 27, Issue:2

    Topics: Acetylcholine; Adolescent; Adult; Aged; Androstanes; Anesthesia, General; Asthma; Bromides; Bronchi;

1972
Status asthmaticus and pancuronium bromide.
    JAMA, 1972, Dec-04, Volume: 222, Issue:10

    Topics: Adolescent; Adult; Androstanes; Asthma; Blood Gas Analysis; Bromides; Carbon Dioxide; Child; Female;

1972
[On the properties of some acyl derivatives of N-4-biphenylmethyltropinium bromide].
    Arzneimittel-Forschung, 1966, Volume: 16, Issue:5

    Topics: Animals; Asthma; Atropine; Biphenyl Compounds; Blood Pressure; Bromides; Bronchodilator Agents; Coro

1966