Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
Information source: IVAX Research LLC
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Albuterol-HFA-MDI (Drug); Albuterol-HFA-BAI (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: IVAX Research LLC Official(s) and/or principal investigator(s):
James W Baker, MD, Principal Investigator, Affiliation: Allergy, Asthma, and Dermatology Research Center, LLC
Grant C Olson, MD, Principal Investigator, Affiliation: Colorado Allergy and Asthma Centers, PC
Paul Qaqundah, MD, Principal Investigator, Affiliation: Pediatric Care Medical Group, Inc.
Overall contact:
Tirsa M Torres, MSEd, Phone: 305-575-6229, Email: Tirsa.Torres@tevaneuro.com
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.
Clinical Details
Official title: Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI/MDI in Asthmatics
Study design: Treatment, Randomized, Open Label, Crossover Assignment
Primary outcome: Improvement in Lung function test over 2 hour period following single dose of investigational drug treatment
Eligibility
Minimum age: 7 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Tirsa M Torres, MSEd, Phone: 305-575-6229, Email: Tirsa.Torres@tevaneuro.com
Pediatric Care Medical Group, Inc., Huntington Beach, California 92647, United States; Recruiting
Tirsa Torres, Phone: 305-575-6229
Colorado Allergy and Asthma Centers, PC, Lakewood, Colorado 80401, United States; Recruiting
Tirsa Torres, Phone: 305-575-6229
Clinical Research Institute, Inc., Minneapolis, Minnesota 55402, United States; Recruiting
Tirsa Torres, Phone: 305-575-6229
Allergy, Asthma, & Clinical Research Center, Oklahoma City, Oklahoma 73120, United States; Recruiting
Tirsa Torres, Phone: 305-575-6229
Allergy, Asthma, and Dermatology Research Center, LLC, Lake Oswego, Oregon 97035, United States; Recruiting
Tirsa Torres, Phone: 305-575-6229
Additional Information
Starting date: January 2007
Ending date: August 2008
Last updated: August 4, 2008
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