glycerol and Cough
glycerol has been researched along with Cough in 10 studies
Moon: The natural satellite of the planet Earth. It includes the lunar cycles or phases, the lunar month, lunar landscapes, geography, and soil.
Cough: A sudden, audible expulsion of air from the lungs through a partially closed glottis, preceded by inhalation. It is a protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions, or to prevent aspiration of foreign materials into the lungs.
Research Excerpts
Excerpt | Relevance | Reference |
---|---|---|
"In a double-blind trial, 29 patients were treated for stable, chronic bronchitis with iodinated glycerol (Organidin, 60 mg four times daily; n = 16) or placebo (n = 13)." | 9.07 | Treatment of stable chronic bronchitis with iodinated glycerol: a double-blind, placebo-controlled trial. ( Repsher, LH, 1993) |
"In a double-blind trial, 29 patients were treated for stable, chronic bronchitis with iodinated glycerol (Organidin, 60 mg four times daily; n = 16) or placebo (n = 13)." | 5.07 | Treatment of stable chronic bronchitis with iodinated glycerol: a double-blind, placebo-controlled trial. ( Repsher, LH, 1993) |
"Prior influenza vaccination had no effect on study outcome." | 2.84 | Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness of a novel dual-action oral topical formulation against upper respiratory infections. ( Adkins, I; Arters, K; Buchheit, K; Esper, F; Ghannoum, MA; Mukherjee, PK; Salata, RA, 2017) |
"An acute cough is usually consequent to upper respiratory tract infections and is self-resolving within a few weeks." | 2.72 | Acute cough in children and adolescents: A systematic review and a practical algorithm by the Italian Society of Pediatric Allergy and Immunology. ( Brambilla, I; Caffarelli, C; Calvani, M; Cardinale, F; Chiappini, E; Ciprandi, G; Cravidi, C; Del Giudice, MM; Duse, M; Licari, A; Manti, S; Marseglia, GL; Martelli, A; Minasi, D; Pajno, G; Peroni, DG; Tosca, MA, 2021) |
"Many products for treating cough contain natural components." | 2.72 | Natural remedies for acute post-viral cough in children. ( Ciprandi, G; De Filippo, M; Marseglia, GL; Murgia, V; Tosca, MA; Votto, M, 2021) |
" Safety endpoints included adverse events, hyperammonemic crises (HACs), and growth and development." | 1.46 | Safety and efficacy of glycerol phenylbutyrate for management of urea cycle disorders in patients aged 2months to 2years. ( Berry, SA; Diaz, GA; Ficicioglu, C; Harding, CO; Lichter-Konecki, U; Longo, N; McCandless, SE; Robinson, B; Smith, WE; Vockley, J; Zori, R, 2017) |
Research
Studies (10)
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 2 (20.00) | 18.7374 |
1990's | 2 (20.00) | 18.2507 |
2000's | 1 (10.00) | 29.6817 |
2010's | 2 (20.00) | 24.3611 |
2020's | 3 (30.00) | 2.80 |
Authors
Authors | Studies |
---|---|
Eccles, R | 1 |
Marseglia, GL | 2 |
Manti, S | 1 |
Chiappini, E | 1 |
Brambilla, I | 1 |
Caffarelli, C | 1 |
Calvani, M | 1 |
Cardinale, F | 1 |
Cravidi, C | 1 |
Duse, M | 1 |
Martelli, A | 1 |
Minasi, D | 1 |
Del Giudice, MM | 1 |
Pajno, G | 1 |
Peroni, DG | 1 |
Tosca, MA | 2 |
Licari, A | 1 |
Ciprandi, G | 2 |
Murgia, V | 1 |
Votto, M | 1 |
De Filippo, M | 1 |
Berry, SA | 1 |
Longo, N | 1 |
Diaz, GA | 1 |
McCandless, SE | 1 |
Smith, WE | 1 |
Harding, CO | 1 |
Zori, R | 1 |
Ficicioglu, C | 1 |
Lichter-Konecki, U | 1 |
Robinson, B | 1 |
Vockley, J | 1 |
Mukherjee, PK | 1 |
Esper, F | 1 |
Buchheit, K | 1 |
Arters, K | 1 |
Adkins, I | 1 |
Ghannoum, MA | 1 |
Salata, RA | 1 |
Repsher, LH | 1 |
Morgan, EJ | 1 |
Petty, TL | 1 |
Block, SH | 1 |
Lewy, RB | 1 |
Clinical Trials (2)
Trial Overview
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
An Open Label Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate (GPB; RAVICTI®) in Pediatric Subjects Under Two Years of Age With Urea Cycle Disorders (UCDs)[NCT02246218] | Phase 4 | 27 participants (Actual) | Interventional | 2014-12-31 | Completed | ||
A Pilot Study of the Safety, Tolerability, and Effectiveness of Halo to Prevent Acute Upper Respiratory Disease and Respiratory Virus Infections[NCT02644135] | 100 participants (Actual) | Interventional | 2013-01-31 | Completed | |||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial Outcomes
Percentage of Participants With Successful Transition to RAVICTI With Controlled Ammonia (i.e. No Clinical Symptoms and Ammonia < 100 μmol/L): Cohort of 0 Months to <2 Months Participants
"The percentage of participants with successful transition is based on Investigator response to the question, Has transition to 100% RAVICTI been successful with controlled ammonia? For participants < 2 months of age, after a minimum of 24 hours of ammonia monitoring following the first full dose of RAVICTI alone, the participant was effectively transitioned when following conditions were met: no signs and symptoms of hyperammonemia; ammonia level less than 100 μmol/L (without normalization of ammonia, ie, without conversion of values from local laboratories with varying normal ranges to standardized values); and eligible for discharge per Investigator judgment." (NCT02246218)
Timeframe: Up to Day 4
Intervention | percentage of participants (Number) |
---|---|
RAVICTI: Age 0 to < 2 Months | 100 |
Percentage of Participants With Successful Transition to RAVICTI With Controlled Ammonia (i.e. No Clinical Symptoms and Ammonia < 100 μmol/L): Cohort of 2 Months to <2 Years Participants
"The percentage of participants with successful transition is based on Investigator response to the question, Has transition to 100% RAVICTI been successful with controlled ammonia? For participants 2 months of age and older, after a minimum of 24 hours of ammonia monitoring following the first full dose of RAVICTI alone, the participant was effectively transitioned when following conditions were met: no signs and symptoms of hyperammonemia; ammonia level less than 100 μmol/L (without normalization of ammonia, ie, without conversion of values from local laboratories with varying normal ranges to standardized values); and eligible for discharge per Investigator judgment." (NCT02246218)
Timeframe: Up to Day 4
Intervention | percentage of participants (Number) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 100 |
Plasma PAA AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 1321.18 |
Plasma PAA AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 246.126 |
Plasma PAA Cmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 115.3 |
Plasma PAA Cmin on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 98.98 |
Plasma PAA Cmin on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 4.197 |
Plasma PAA Tmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 9.85 |
Plasma PAA Tmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 7.422 |
Plasma PAGN AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 1384.12 |
Plasma PAGN AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 583.835 |
Plasma PAGN Cmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 102.1 |
Plasma PAGN Cmin on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 69.39 |
Plasma PAGN Cmin on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 20.62 |
Plasma PAGN Tmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 11.72 |
Plasma PAGN Tmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 6.573 |
Plasma PBA Area Under the Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-last]) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 280.936 |
Plasma PBA AUC(0-last) on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg*hr/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 374.53 |
Plasma PBA Cmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 46.2 |
Plasma PBA Cmin on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 4.8 |
Plasma PBA Minimum Plasma Concentration (Cmin) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 1.697 |
Plasma PBA Time to Cmax (Tmax) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 8.383 |
Plasma PBA Tmax on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | hours (Mean) |
---|---|
RAVICTI: Age 0 to < 2 Months | 9.39 |
Plasma Phenylacetate/Phenylacetic Acid (PAA) Cmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 36.52 |
Plasma Phenylacetylglutamine (PAGN) Cmax on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 62.45 |
Plasma Phenylbutyrate/Phenylbutyric Acid (PBA) Maximum Plasma Concentration (Cmax) on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 4 and 6 hours, 8 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 42.44 |
Rate of HACs: Cohort of 0 Months to <2 Months Participants
HAC is defined as having signs and symptoms consistent with hyperammonemia (such as but not limited to frequent vomiting, nausea, headache, lethargy, irritability, combativeness, and/or somnolence) associated with high blood ammonia and requiring medical intervention. Rate of HACs per 6 months during the safety extension was calculated as sum of (number of HAC) / sum of (days during first 6 months starting on Day 8 or number days on RAVICTI, whichever is less) across all participants in the corresponding group. (NCT02246218)
Timeframe: Day 8 through up to Month 6
Intervention | HACs per half-year of patient exposure (Number) |
---|---|
RAVICTI: Age 0 to < 2 Months | 0.003 |
Rate of Hyperammonemic Crises (HACs): Cohort of 2 Months to <2 Years Participants
HAC is defined having signs and symptoms consistent with hyperammonemia (such as but not limited to frequent vomiting, nausea, headache, lethargy, irritability, combativeness, and/or somnolence) associated with high blood ammonia and requiring medical intervention. Rate of HACs per 6 months during the safety extension is calculated as sum of (number of HAC) / sum of (days during first 6 months starting on Day 8 or number days on RAVICTI, whichever is less) across all participants in the corresponding group. (NCT02246218)
Timeframe: Day 8 through up to Month 6
Intervention | HACs per half-year of patient exposure (Number) |
---|---|
RAVICTI: Age 2 Months to < 2 Years | 0.005 |
Amino Acid Assessment: Baseline and Change From Baseline in Glutamate Up to Month 24: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 84.97 | 26.81 | 25.16 | 50.05 | 18.77 | 57.43 | 43.65 | 33.41 | 8.75 | 25.75 | 2.50 | 16.10 |
Amino Acid Assessment: Baseline and Change From Baseline in Glutamate Up to Month 24: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 122.43 | -54.50 | 7.80 | -16.33 | -13.00 | 0.25 | -2.20 | 30.80 | 22.20 | 39.00 | 48.00 |
Amino Acid Assessment: Baseline and Change From Baseline in Glutamine Up to Month 24: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 508.83 | 21.04 | -27.62 | -15.09 | -113.98 | -99.82 | -138.16 | -56.08 | -181.50 | -103.75 | -184.00 | -219.93 |
Amino Acid Assessment: Baseline and Change From Baseline in Glutamine Up to Month 24: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 750.43 | -184.33 | -174.60 | -374.00 | -252.75 | -370.25 | -113.20 | -446.53 | -450.50 | -149.00 | 195.00 |
Amino Acid Assessment: Baseline and Change From Baseline in Isoleucine Up to Month 24: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 142.68 | -49.09 | -1.62 | -20.46 | -67.32 | -75.45 | -35.94 | -73.09 | -178.50 | -139.50 | 1.00 | -55.31 |
Amino Acid Assessment: Baseline and Change From Baseline in Isoleucine Up to Month 24: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 54.86 | 2.67 | 4.20 | -25.67 | -20.25 | -20.00 | -16.40 | -6.73 | -13.33 | -18.00 | 1.50 |
Amino Acid Assessment: Baseline and Change From Baseline in Leucine Up to Month 24: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 133.67 | -81.91 | -60.80 | -51.66 | -82.82 | -118.55 | -11.85 | -115.09 | -249.50 | -195.75 | 6.00 | -82.54 |
Amino Acid Assessment: Baseline and Change From Baseline in Leucine Up to Month 24: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 90.86 | -0.83 | 9.80 | -33.00 | -31.25 | -39.50 | -25.40 | -19.13 | -34.37 | -40.00 | -1.50 |
Amino Acid Assessment: Baseline and Change From Baseline in Sum of Glutamine and Glutamate Up to Month 24: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 593.80 | 47.85 | -2.46 | 34.96 | -95.21 | -42.39 | -94.51 | -22.66 | -172.75 | -78.00 | -181.50 | -203.83 |
Amino Acid Assessment: Baseline and Change From Baseline in Sum of Glutamine and Glutamate Up to Month 24: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 872.86 | -238.83 | -166.80 | -390.33 | -265.75 | -370.00 | -115.40 | -415.73 | -428.30 | -110.00 | 243.00 |
Amino Acid Assessment: Baseline and Change From Baseline in Valine Up to Month 24: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | μmol/L (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | 181.49 | -63.96 | -39.04 | -23.86 | -74.41 | -98.67 | 2.64 | -90.40 | -238.25 | -137.00 | 38.00 | -72.78 |
Amino Acid Assessment: Baseline and Change From Baseline in Valine Up to Month 24: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Baseline, Day 7, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 24
Intervention | µmol/L (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Day 7 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 171.43 | 4.00 | 40.60 | -27.33 | -31.50 | -56.00 | -21.60 | -11.90 | -48.87 | -46.00 | 5.00 |
Assessment of Growth and Development: Baseline and Change From Baseline in BMI Z-Score Up to Month 24: Cohort of 0 Months to <2 Months Participants
To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BMI. The Z-scores are based on the World Health Organization's Child Growth Standards charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | -0.0544 | -0.2158 | -0.2598 | -0.1617 | -0.0264 | 0.0828 | 0.0136 | 0.4614 | 0.6646 | 0.6830 | 0.3308 | 0.7743 |
Assessment of Growth and Development: Baseline and Change From Baseline in Body Mass Index (BMI) Z-Score Up to Month 24: Cohort of 2 Months to <2 Years Participants
To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BMI. The Z-scores are based on the World Health Organization's Child Growth Standards charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 0.8107 | -0.2385 | -0.0249 | 0.1815 | 0.4434 | 0.1484 | 0.2497 | 0.6407 | 0.4164 | -0.2997 | -0.2038 | 0.5581 |
Assessment of Growth and Development: Baseline and Change From Baseline in Body Surface Area (BSA) Z-Score Up to Month 24: Cohort of 2 Months to <2 Years Participants
To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BSA. The Z-scores are based on weight-for-length charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 2 Months to < 2 Years | 0.7143 | -0.2105 | -0.0704 | 0.1065 | 0.3365 | 0.1043 | 0.1842 | 0.4875 | 0.2944 | -0.3661 | -0.2214 | 0.4310 |
Assessment of Growth and Development: Baseline and Change From Baseline in BSA Z-Score Up to Month 24: Cohort of 0 Months to <2 Months Participants
To assess any effect of study drug treatment on growth, Z-scores were calculated to express the deviation from a reference population for BSA. The Z-scores are based on weight-for-length charts. Negative Z-scores indicate lower than typical for age and gender while positive scores indicate higher than typical for age and gender. (NCT02246218)
Timeframe: Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, Month 24
Intervention | z-score (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Baseline | Month 1 change from Baseline | Month 2 change from Baseline | Month 3 change from Baseline | Month 4 change from Baseline | Month 5 change from Baseline | Month 6 change from Baseline | Month 9 change from Baseline | Month 12 change from Baseline | Month 15 change from Baseline | Month 18 change from Baseline | Month 24 change from Baseline | |
RAVICTI: Age 0 to < 2 Months | -0.1980 | 0.2336 | 0.2006 | 0.2684 | 0.2372 | 0.1810 | 0.2902 | 0.1679 | 0.1308 | 0.1595 | 0.1050 | 0.7341 |
Assessment of Urinary PAA Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1.5 hours, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 0 to < 2 Months | 11.1 | 46.2 | 62.5 | 34.6 | 22.8 | 35.2 |
Assessment of Urinary PAA Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1.5 hours, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 2 Months to < 2 Years | 18.78 | 6.50 | 7.29 | 2.60 | 4.48 | 4.31 |
Assessment of Urinary PAA Concentrations Up to End of Trial: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 15, End of Trial (up to Month 15)
Intervention | μg/mL (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Day 7 | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 9 | Month 12 | Month 15 | End of trial | |
RAVICTI: Age 0 to < 2 Months | 23.7 | 14.6 | 12.3 | 14.4 | 6.4 | 13.2 | 5.5 | 11.8 | 6.0 | 4.9 | 11.6 |
Assessment of Urinary PAA Concentrations Up to End of Trial: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 15, Month 18, End of Trial (up to Month 18)
Intervention | μg/mL (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Day 7 | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 9 | Month 15 | Month 18 | End of trial | |
RAVICTI: Age 2 Months to < 2 Years | 5.82 | 4.44 | 3.69 | 4.65 | 7.14 | 3.27 | 1.59 | 4.10 | 2.04 | 1.64 | 7.0 |
Assessment of Urinary PAGN Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1 hour, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 0 to < 2 Months | 3530.43 | 1828 | 1746 | 2260 | 3530.43 | 4404 |
Assessment of Urinary PAGN Concentrations on the First Full Day of RAVICTI Dosing: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Hour 0 and between 0.5 and 1 hour, 1.5 and 2.5 hours, 4 and 6 hours, 7.5 and 8.5 hours, and between 12 and 24 hours after the first dose of the day on Day 1 for stable participants and on Day 2 for participants in HAC
Intervention | μg/mL (Mean) | |||||
---|---|---|---|---|---|---|
Hour 0 | 0.5 to 1.5 hours | 1.5 to 2.5 hours | 4 to 6 hours | 7.5 to 8.5 hours | 12 to 24 hours | |
RAVICTI: Age 2 Months to < 2 Years | 3273 | 4140 | 3145 | 5202 | 3950 | 7561 |
Assessment of Urinary PAGN Concentrations Up to End of Trial: Cohort of 0 Months to <2 Months Participants
(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, End of Trial (up to Month 15)
Intervention | μg/mL (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Day 7 | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 9 | Month 12 | Month 15 | End of trial | |
RAVICTI: Age 0 to < 2 Months | 4643 | 4517 | 4116 | 7037 | 2826 | 6973 | 5883 | 7006 | 5847 | 3915 | 6939 |
Assessment of Urinary PAGN Concentrations Up to End of Trial: Cohort of 2 Months to <2 Years Participants
(NCT02246218)
Timeframe: Day 7, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6, Month 9, Month 12, Month 15, Month 18, End of Trial (up to Month 18)
Intervention | μg/mL (Mean) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
Day 7 | Month 1 | Month 2 | Month 3 | Month 4 | Month 5 | Month 6 | Month 9 | Month 12 | Month 15 | Month 18 | End of trial | |
RAVICTI: Age 2 Months to < 2 Years | 8859 | 6274 | 7386 | 11456 | 21416 | 6129 | 5347 | 9357 | 2580 | 6400 | 5250 | 25333 |
Number of Participants With TEAEs, Serious TEAEs, Deaths, and Discontinuations Due to TEAEs: Cohort of 0 Months to <2 Months Participants
An AE is any untoward medical occurrence, whether or not the event is considered related to the study drug. A serious AE is any AE that: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. TEAEs are defined as AEs with an onset date on or after the first dose of study medication until study discontinuation. The Investigator assessed the causal relationship of each TEAE to the study drug as not related, possibly related, or probably related. (NCT02246218)
Timeframe: From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 10.67 [6.142] months).
Intervention | Participants (Count of Participants) | |||||
---|---|---|---|---|---|---|
≥ 1 TEAE | ≥ 1 Related TEAE | ≥ 1 Serious TEAE | ≥ 1 Serious Related TEAE | Fatal Outcome TEAE | ≥ 1 TEAE Leading to Study Discontinuation | |
RAVICTI: Age 0 to < 2 Months | 16 | 10 | 11 | 0 | 0 | 1 |
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Deaths, and Discontinuations Due to TEAEs: Cohort of 2 Months to <2 Years Participants
An adverse event (AE) is any untoward medical occurrence, whether or not the event is considered related to the study drug. A serious AE is any AE that: results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; is an important medical event. TEAEs are defined as AEs with an onset date on or after the first dose of study medication until study discontinuation. The Investigator assessed the causal relationship of each TEAE to the study drug as not related, possibly related, or probably related. (NCT02246218)
Timeframe: From the first dose of study treatment through 30 days after the final dose (mean [SD] duration of treatment was 9.13 [6.838] months).
Intervention | Participants (Count of Participants) | |||||
---|---|---|---|---|---|---|
≥ 1 TEAE | ≥ 1 Related TEAE | ≥ 1 Serious TEAE | ≥ 1 Serious Related TEAE | Fatal Outcome TEAE | ≥ 1 TEAE Leading to Study Discontinuation | |
RAVICTI: Age 2 Months to < 2 Years | 10 | 4 | 6 | 0 | 1 | 1 |
Number of Acute Respiratory Illnesses
Measured by medical record review. (NCT02644135)
Timeframe: Through study duration, an average of 3 months
Intervention | Number of acute respiratory illnesses (Number) |
---|---|
Halo Oral Spray | 4 |
Halo Placebo | 2 |
Number of Participants That Develop Acute Respiratory Illnesses When Using Halo vs Placebo
(NCT02644135)
Timeframe: Through study duration, an average of 3 months
Intervention | participants (Number) |
---|---|
Halo Oral Spray | 2 |
Halo Placebo | 4 |
Reviews
3 reviews available for glycerol and Cough
Article | Year |
---|---|
The Powerful Placebo Effect in Cough: Relevance to Treatment and Clinical Trials.
Topics: Antitussive Agents; Clinical Trials as Topic; Coloring Agents; Cough; Flavoring Agents; Glycerol; Ho | 2020 |
Acute cough in children and adolescents: A systematic review and a practical algorithm by the Italian Society of Pediatric Allergy and Immunology.
Topics: Acute Disease; Adolescent; Allergy and Immunology; Antitussive Agents; Apitherapy; Child; Child, Pre | 2021 |
Natural remedies for acute post-viral cough in children.
Topics: Acute Disease; Adolescent; Antitussive Agents; Apitherapy; Biological Products; Child; Cough; Glycer | 2021 |
Trials
3 trials available for glycerol and Cough
Article | Year |
---|---|
Randomized, double-blind, placebo-controlled clinical trial to assess the safety and effectiveness of a novel dual-action oral topical formulation against upper respiratory infections.
Topics: Administration, Oral; Administration, Topical; Adolescent; Adult; Anti-Infective Agents, Local; Cety | 2017 |
Treatment of stable chronic bronchitis with iodinated glycerol: a double-blind, placebo-controlled trial.
Topics: Adult; Bronchitis; Chronic Disease; Cough; Double-Blind Method; Expectorants; Female; Glycerol; Huma | 1993 |
Summary of the National Mucolytic Study.
Topics: Aged; Bronchitis; Chest Pain; Consumer Behavior; Cough; Double-Blind Method; Expectorants; Female; G | 1990 |
Other Studies
4 other studies available for glycerol and Cough
Article | Year |
---|---|
Safety and efficacy of glycerol phenylbutyrate for management of urea cycle disorders in patients aged 2months to 2years.
Topics: Ammonia; Child, Preschool; Cough; Disease Management; Drug-Related Side Effects and Adverse Reaction | 2017 |
Best drugs for what ails you: the brands to buy--and those to skip.
Topics: Acetaminophen; Anesthetics, Local; Cetirizine; Chlorpheniramine; Common Cold; Cough; Dextromethorpha | 2009 |
Goiter complicating therapy with iodinated glycerol (Organidin).
Topics: Adolescent; Cough; Expectorants; Female; Follow-Up Studies; Glycerol; Goiter; Humans; Iodine; Thyroi | 1973 |
Tracheotomy avoidance. Glycerine vocal cord injection.
Topics: Aged; Aorta; Cough; Female; Fluorocarbon Polymers; Glottis; Glycerol; Humans; Injections; Laryngosco | 1970 |