Official Title: “Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI/MDI in Asthmatics”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment

Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Albuterol Inhaler
• Active Comparator: 2
  • Albuterol Inhaler

Primary Measures

• Improvement in Lung function test over 2 hour period following single dose of investigational drug treatment
  • Time Frame: For up to 2 hour post treatment
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 7 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: IVAX Research LLC

Overall Clinical Trial Officials and Contacts

James W Baker, MD Principal Investigator Allergy, Asthma, and Dermatology Research Center, LLC  

Overall Contact: Tirsa M Torres, MSEd 305-575-6229 Tirsa.Torres@tevaneuro.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00530062

Study ID Number: IXR-404-04-167

ClinicalTrials.gov Identifier: NCT00530062

Health Authority: United States: Food and Drug Administration