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Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
This study is currently recruiting participants.
Verified by IVAX Research LLC, August 2008
Sponsored by: IVAX Research LLC
Information provided by: IVAX Research LLC
ClinicalTrials.gov Identifier: NCT00530062
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Albuterol-HFA-MDI
Drug: Albuterol-HFA-BAI
Phase IV

MedlinePlus related topics: Allergy Asthma
Drug Information available for: Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Crossover Assignment
Official Title: Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI/MDI in Asthmatics

Further study details as provided by IVAX Research LLC:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2007
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Albuterol Inhaler
Drug: Albuterol-HFA-MDI
Inhalation Aerosols, 90 mcg, 1 dose per treatment period
2: Active Comparator
Albuterol Inhaler
Drug: Albuterol-HFA-BAI
Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.

  Eligibility

Ages Eligible for Study:   7 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530062

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

Locations
United States, California
Pediatric Care Medical Group, Inc. Recruiting
Huntington Beach, California, United States, 92647
Contact: Tirsa Torres     305-575-6229        
United States, Colorado
Colorado Allergy and Asthma Centers, PC Recruiting
Lakewood, Colorado, United States, 80401
Contact: Tirsa Torres     305-575-6229        
United States, Minnesota
Clinical Research Institute, Inc. Recruiting
Minneapolis, Minnesota, United States, 55402
Contact: Tirsa Torres     305-575-6229        
United States, Oklahoma
Allergy, Asthma, & Clinical Research Center Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Tirsa Torres     305-575-6229        
United States, Oregon
Allergy, Asthma, and Dermatology Research Center, LLC Recruiting
Lake Oswego, Oregon, United States, 97035
Contact: Tirsa Torres     305-575-6229        
Sponsors and Collaborators
IVAX Research LLC
Investigators
Principal Investigator: James W Baker, MD Allergy, Asthma, and Dermatology Research Center, LLC
Principal Investigator: Grant C Olson, MD Colorado Allergy and Asthma Centers, PC
Principal Investigator: Paul Qaqundah, MD Pediatric Care Medical Group, Inc.
  More Information

Responsible Party: IVAX Research, LLC ( Tirsa Torres )
Study ID Numbers: IXR-404-04-167
Study First Received: September 14, 2007
Last Updated: August 4, 2008
ClinicalTrials.gov Identifier: NCT00530062  
Health Authority: United States: Food and Drug Administration

Keywords provided by IVAX Research LLC:
Asthma and Poor Coordinators of Asthma Inhalers

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Albuterol
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Reproductive Control Agents
Adrenergic Agonists
Pharmacologic Actions
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009