Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma

Study Overview
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Brief Summary
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This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.

Official Title
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Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability

Conditions
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Asthma

Intervention / Treatment
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* Drug: Albuterol-HFA-MDI
* Drug: Albuterol-HFA-BAI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Asthma of a minimum of 6 months duration Participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the Aerosol Inhalation Monitor (AIM, Vitalograph) prior to any training and following training in 3 consecutive attempts Reversible bronchoconstriction of >12% increase in FEV1 with a cumulative dose of 450 mcg of albuterol The reversibility (FEV1) of ≤70% following administration of the initial 90 mcg of albuterol Ability to perform spirometry reproducibly Ability to self-perform peak expiratory flow (PEF) determinations and report scores on diaries Can tolerate withdrawal of applicable medications for qualification at screening Otherwise healthy individuals Non-smokers for at least 2 years prior to the screening visit Exclusion Criteria: Allergy or sensitivity to albuterol Exposure to investigational drugs within 30 days prior to the screening visit Continuous treatment with beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids Treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit The prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit Inability to tolerate or unwillingness to comply with required washout periods for all applicable medications Hospitalization for acute exacerbation of asthma more than twice in past year Treatment in an emergency room or hospitalization for asthmatic symptoms within 3 months prior to the screening visit An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved 3 weeks prior to the screening visit History and/or presence of any clinically significant non-asthmatic acute or chronic disease Known or suspected substance abuse Previous enrollment in an IVAX Research-sponsored Albuterol-HFA asthma study Note: Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albuterol-HFA-BAI<br>Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2. | Drug: Albuterol-HFA-BAI<br>* Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.<br>* Other names: Albuterol;|
| Active Comparator: Albuterol-HFA-MDI<br>Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2. | Drug: Albuterol-HFA-MDI<br>* Inhalation Aerosols, 90 mcg, 1 dose per treatment period<br>* Other names: ProAir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area-Under-the-Effect Curve of Percent Change in Test-Day Baseline Forced Expiratory Volume in 1 Second (FEV1) Versus Time (up to 2 Hours Postdose), %FEV1 AUEC0-2 | The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The baseline value consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period. | Baseline, Up to 2 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in FEV1 Within 30 Minutes Postdose | The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period. | Baseline up to 30 minutes postdose | 
| Percent Change From Baseline in FEV1 up to 2 Hours Postdose | The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period. | Baseline up to 2 hours postdose | 
| Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2 | The %FEV1 AUEC0-2 was calculated using the linear trapezoidal rule. The test-day baseline consisted of the average of the two predose FEV1 measurements. The mean was obtained from the mixed-effect analysis of variance adjusted for effects from the study center, the treatment sequence, and study period. | Baseline up to 2 hours postdose | 
| Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose |  | Baseline up to 2 hours postdose | 
| Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose |  | Baseline up to 2 hours postdose | 
| Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose | The number of minutes required for the baseline FEV1 to increase by at least 12% within the 2-hour observation period. Median time and corresponding confidence intervals (CIs) were obtained via the Kaplan-Meier estimate. | Baseline up to 2 hours postdose | 
| Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose | The number of minutes required for the baseline FEV1 to increase by at least 15% within the 2-hour observation period. Median time and corresponding CIs were obtained via the Kaplan-Meier estimate. | Baseline up to 2 hours postdose | 
| Time to Maximum Increase in FEV1 | Each calculation for FEV1 took several minutes in order to obtain the highest of 3 measurements. The total collection time exceeded the 120 mins post-dose time frame for some participants. | Baseline up to 2 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma and Poor Coordinators of Asthma Inhalers