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
Completed · Phase 4
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT00530062
- Run by
- Teva Branded Pharmaceutical Products R&D, Inc.
- People needed
- 49
- Starts
- 2007-07-25
- Expected to finish
- 2008-10-24
- Last updated by the study team
- 2022-09-07
Who can join
Age: 7 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Clinical Study Site — Huntington Beach, California, United States
- Teva Clinical Study Site — Lakewood, Colorado, United States
- Clinical Study Site — Minneapolis, Minnesota, United States
- Clinical Study Site — Oklahoma City, Oklahoma, United States
- Clinical Study Site — Lake Oswego, Oregon, United States
Full record on ClinicalTrials.gov
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