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
- Conditions
- Asthma
- Interventions
- Drug: Albuterol-HFA-BAIDrug: Albuterol-HFA-MDI
- Registration Number
- NCT00530062
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Albuterol-HFA-BAI Albuterol-HFA-BAI Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2. Albuterol-HFA-MDI Albuterol-HFA-MDI Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2.
- Primary Outcome Measures
Name Time Method 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 Baseline, Up to 2 hours postdose 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.
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in FEV1 Within 30 Minutes Postdose Baseline up to 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.
Percent Change From Baseline in FEV1 up to 2 Hours Postdose Baseline 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.
Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2 Baseline up to 2 hours postdose 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.
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 Baseline up to 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.
Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose Baseline up to 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.
Time to Maximum Increase in FEV1 Baseline up to 2 hours postdose 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.
Trial Locations
- Locations (2)
Teva Clinical Study Site
🇺🇸Lakewood, Colorado, United States
Clinical Study Site
🇺🇸Lake Oswego, Oregon, United States