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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 Teva Global Respiratory Research LLC, August 2008
First Received: September 14, 2007   Last Updated: August 4, 2008   History of Changes
Sponsored by: Teva Global Respiratory Research LLC
Information provided by: Teva Global Respiratory 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

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

Resource links provided by NLM:


Further study details as provided by Teva Global Respiratory 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
Teva Global Respiratory 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

No publications provided

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     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Global Respiratory Research LLC:
Asthma and Poor Coordinators of Asthma Inhalers

Study placed in the following topic categories:
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchial Diseases
Adrenergic Agents
Albuterol
Asthma
Anti-Asthmatic Agents
Adrenergic Agonists
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on July 02, 2009