Comparison of Single-Dose of Albuterol Breath Activated Inhaler Versus Albuterol Metered Dose Inhaler in Asthmatics

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a research study designed to compare the single-dose effectiveness of albuterol-HFA-BAI (breath activated inhaler) and albuterol-HFA-MDI (metered dose inhaler) in asthmatics with poor inhaler coordinating abilities. Patients must be 7 to 70 years of age to participate in this study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.; Teva Branded Pharmaceutical Products, R&D Inc.
• Treatments: Albuterol

Criteria

Inclusion Criteria:

• Male or females aged 7-70 years old

• Asthma of a minimum of 6 months duration

• Patients who demonstrate poor inhalation/actuation coordination when evaluated with the AIM -Aerosol Inhalation Monitor.

• 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 PEF determinations and report scores on diaries

• Can tolerate withdrawal of applicable medications at screening

• Otherwise healthy individuals

• Non-smokers for at least two years

Exclusion Criteria:

• Allergy or sensitivity to albuterol

• Exposure to investigational drugs within 30 days prior to the screening visit

• Continuous treatment with Beta-blockers, MAO inhibitors, tricyclic antidepressants, and/or systemic corticosteroids

• Treated with oral or injectable corticosteroids within the six weeks prior to the screening visit

• Unstable dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil

• 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 three months prior to the screening visit

• An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved three 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

• Other criteria apply