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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530062
• Other study ID #: IXR-404-04-167
• Status: Completed
• Phase: Phase 4
• Start date: July 25, 2007
• Est. completion date: October 24, 2008

Study information

• Verified date: August 2022
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: October 24, 2008
• Est. primary completion date: October 24, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Albuterol-HFA-MDI
Inhalation Aerosols, 90 mcg, 1 dose per treatment period
• Albuterol-HFA-BAI
Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.

Locations

Country	Name	City	State
United States	Clinical Study Site	Huntington Beach	California
United States	Clinical Study Site	Lake Oswego	Oregon
United States	Teva Clinical Study Site	Lakewood	Colorado
United States	Clinical Study Site	Minneapolis	Minnesota
United States	Clinical Study Site	Oklahoma City	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose		Baseline up to 2 hours postdose
Secondary	Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose		Baseline up to 2 hours postdose
Secondary	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
Secondary	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
Secondary	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