Clinical trial NCT00530062: 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
Official title: Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: Asthma and Poor Coordinators of Asthma Inhalers
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2007-09-17
Enrollment: 49
Sex: ALL
Minimum age (years): 7
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Baseline, Up to 2 hours postdose
Secondary outcomes:
measure: Percent Change From Baseline in FEV1 Within 30 Minutes Postdose
timeFrame: Baseline up to 30 minutes postdose
measure: Percent Change From Baseline in FEV1 up to 2 Hours Postdose
timeFrame: Baseline up to 2 hours postdose
measure: Area-Under-the-Effect Curve of Change in Test-Day Baseline FEV1 Versus Time (up to 2 Hours Postdose), FEV1 AUEC0-2
timeFrame: Baseline up to 2 hours postdose
measure: Percentage of Participants With a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
timeFrame: Baseline up to 2 hours postdose
measure: Percentage of Participants With a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
timeFrame: Baseline up to 2 hours postdose
measure: Time to a 12% Increase From Baseline in FEV1 Within 2 Hours Postdose
timeFrame: Baseline up to 2 hours postdose
measure: Time to a 15% Increase From Baseline in FEV1 Within 2 Hours Postdose
timeFrame: Baseline up to 2 hours postdose
measure: Time to Maximum Increase in FEV1
timeFrame: Baseline up to 2 hours postdose
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Clinical Study Site
state: California
city: Lakewood
country: United States
facility: Teva Clinical Study Site
state: Colorado
city: Minneapolis
country: United States
facility: Clinical Study Site
state: Minnesota
city: Oklahoma City
country: United States
facility: Clinical Study Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: Clinical Study Site
state: Oregon
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: