albuterol and Acute Symptom Flare studies

Albuterol: A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol.
albuterol : A member of the class of phenylethanolamines that is 4-(2-amino-1-hydroxyethyl)-2-(hydroxymethyl)phenol having a tert-butyl group attached to the nirogen atom. It acts as a beta-adrenergic agonist used in the treatment of asthma and chronic obstructive pulmonary disease (COPD).

Research Excerpts

Excerpt	Relevance	Reference
"We conducted a multinational, phase 3, double-blind, randomized, event-driven trial to evaluate the efficacy and safety of albuterol-budesonide, as compared with albuterol alone, as rescue medication in patients with uncontrolled moderate-to-severe asthma who were receiving inhaled glucocorticoid-containing maintenance therapies, which were continued throughout the trial."	9.51	Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. ( Albers, FC; Beasley, R; Cappelletti, C; Chipps, BE; Cooper, M; Dunsire, L; Israel, E; Jeynes-Ellis, A; Johnsson, E; Panettieri, RA; Papi, A; Rees, R, 2022)
"We conducted a multinational, phase 3, double-blind, randomized, event-driven trial to evaluate the efficacy and safety of albuterol-budesonide, as compared with albuterol alone, as rescue medication in patients with uncontrolled moderate-to-severe asthma who were receiving inhaled glucocorticoid-containing maintenance therapies, which were continued throughout the trial."	5.51	Albuterol-Budesonide Fixed-Dose Combination Rescue Inhaler for Asthma. ( Albers, FC; Beasley, R; Cappelletti, C; Chipps, BE; Cooper, M; Dunsire, L; Israel, E; Jeynes-Ellis, A; Johnsson, E; Panettieri, RA; Papi, A; Rees, R, 2022)

Research

Studies (1)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Annualized Severe Exacerbation Rate

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	0 (0.00)	24.3611
2020's	1 (100.00)	2.80

Authors	Studies
Papi, A	1
Chipps, BE	1
Beasley, R	1
Panettieri, RA	1
Israel, E	1
Cooper, M	1
Dunsire, L	1
Jeynes-Ellis, A	1
Johnsson, E	1
Rees, R	1
Cappelletti, C	1
Albers, FC	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Long-term, Randomized, Double-blind, Multicenter, Parallel-group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT007 Administered as Needed in Response to Symptoms in Symptomatic Adults and Children 4 Years of Age or Older Wit[NCT03769090]	Phase 3	3,132 participants (Actual)	Interventional	2018-12-13	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

The annualized severe exacerbation rate (severe exacerbations per year) is estimated from a negative binomial model with treatment, age group, region, and number of severe exacerbations in the last 12 months prior to randomization as categorical covariates. The logarithm of the time at risk is included as an offset variable. (NCT03769090)
Timeframe: From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.

Asthma Control Questionnaire-5 (ACQ-5) - Number of Participants Who Were Responders at Week 24

Intervention	Severe exacerbations per year (Least Squares Mean)
BDA MDI 160/180 μg (Full Analysis Set; >=12 Years)	0.45
AS MDI 180 μg (Full Analysis Set; >=12 Years)	0.59
BDA MDI 80/180 μg (Full Analysis Set)	0.49
AS MDI 180 μg (Full Analysis Set)	0.61

The ACQ-5 consists of 5 questions on symptom control, with each scored on a 7-point scale (0 = excellent asthma control; 6 = extremely poor control). The overall score (0 = excellent asthma control; 6 = extremely poor control, so a lower score is the better outcome) is the mean of the 5 symptom items. A responder is defined as a participant with a decrease from baseline to Week 24 overall ACQ-5 score of 0.5 or more. ACQ-5 is not validated for children less than 6 years old, data for participants who were 4 or 5 years old was excluded from the analysis of ACQ-5. (NCT03769090)
Timeframe: From baseline to Week 24

Asthma Quality of Life Questionnaire for Participants Aged 12 Years and Older (AQLQ+12) - Number of Participants Who Were Responders at Week 24

Intervention	Participants (Count of Participants)
BDA MDI 160/180 μg (Full Analysis Set; >=12 Years)	677
AS MDI 180 μg (Full Analysis Set; >=12 Years)	630
BDA MDI 80/180 μg (Full Analysis Set)	681
AS MDI 180 μg (Full Analysis Set)	650

The AQLQ+12 consists of 32 questions in 4 domains and is assessed on separate 7-point Likert scales from 1 to 7, with higher values indicating better health-related quality of life. The overall score is the mean of all responses. A responder is defined as a participant with an increase from baseline to week 24 AQLQ-12 score of at least 0.5. (NCT03769090)
Timeframe: From baseline to 24 weeks

Number of Participants With a Severe Asthma Exacerbation Event

Intervention	Participants (Count of Participants)
BDA MDI 160/180 μg (Full Analysis Set; >=12 Years)	508
BDA MDI 80/180 μg (Full Analysis Set; >=12 Years)	489
AS MDI 180 μg (Full Analysis Set; >=12 Years)	461

Time to first severe asthma exacerbation will be calculated as the time from randomization until the start date of the first severe asthma exacerbation. An asthma exacerbation will be considered severe if it results in at least one of the following: a temporary bolus/burst of systemic corticosteroids for at least 3 consecutive days to treat symptoms of asthma worsening (a single depo-injectable dose of corticosteroids will be considered equivalent), an emergency room or urgent care visit (<24 hours in the facility for evaluation and treatment) due to asthma that required systemic corticosteroids, or an in-patient hospitalization (admission to an in-patient facility and/or ≥ 24 hours in a healthcare facility) due to asthma. The descriptive summary shows the number of participants with a severe exacerbation event, occurring between the date of randomization up to the date of randomized treatment discontinuation or a change in maintenance therapy. (NCT03769090)
Timeframe: From randomization up to a discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.

Total Annualized Dose of Systemic Corticosteroid (SCS)

Intervention	Participants (Count of Participants)
BDA MDI 160/180 μg (Full Analysis Set; >=12 Years)	207
AS MDI 180 μg (Full Analysis Set; >=12 Years)	266
BDA MDI 80/180 μg (Full Analysis Set)	241
AS MDI 180 μg (Full Analysis Set)	276

This endpoint includes all systemic corticosteroids (SCS) taken in response to a severe exacerbation event from randomization up to randomized treatment discontinuation or a change in maintenance therapy. All SCS are standardized to equipotent doses of prednisone before deriving the total dose. The total annualized dose is calculated as the total dose of SCS divided by the duration of the randomized treatment period. (NCT03769090)
Timeframe: From randomization up to discontinuation of randomized treatment or a change in maintenance therapy. The mean and median reporting period for all participants was 44 and 48 weeks, respectively.

Intervention	Milligram(s) (Mean)
BDA MDI 160/180 μg (Full Analysis Set; >=12 Years)	86.2
AS MDI 180 μg (Full Analysis Set; >=12 Years)	129.3
BDA MDI 80/180 μg (Full Analysis Set)	95.5
AS MDI 180 μg (Full Analysis Set)	127.1