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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00530062
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : January 12, 2018
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. )

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Albuterol-HFA-MDI Drug: Albuterol-HFA-BAI Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability
Study Start Date : January 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: Albuterol HFA-BAI
Albuterol Hydrofluoroalkane (HFA) Breath-Actuated Inhaler (BAI)
Drug: Albuterol-HFA-BAI
Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.
Other Name: Albuterol

Active Comparator: Albuterol HFA-MDI
Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI)
Drug: Albuterol-HFA-MDI
Inhalation Aerosols, 90 mcg, 1 dose per treatment period
Other Names:
  • Albuterol
  • ProAir

Primary Outcome Measures :
  1. The percent change in the area-under-the-effect curve from test day baseline FEV1 versus time [ Time Frame: Baseline to two hours post dose, Study Days 1 and 2 ]

Secondary Outcome Measures :
  1. The maximum percent increase in FEV1 (%) from baseline within the scheduled first 30 minutes of spirometric evaluations post dose [ Time Frame: Baseline to thirty minutes post dose, Study Days 1 and 2 ]
  2. The maximum percent increase in FEV1 from baseline over 2 hours [ Time Frame: Baseline to two hours post dose, Study days 1 and 2 ]
  3. The area-under-the-effect curve of change in FEV1 from test-day baseline versus time [ Time Frame: Baseline to two hours post dose, Study days 1 and 2 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   7 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   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
  • Other criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00530062

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United States, California
Clinical Study Site
Huntington Beach, California, United States, 92647
United States, Colorado
Teva Clinical Study Site
Lakewood, Colorado, United States, 80401
United States, Minnesota
Clinical Study Site
Minneapolis, Minnesota, United States, 55402
United States, Oklahoma
Clinical Study Site
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Clinical Study Site
Lake Oswego, Oregon, United States, 97035
Sponsors and Collaborators
Teva Branded Pharmaceutical Products, R&D Inc.
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Study Chair: Clinical Study Leader Teva Branded Pharmaceutical Products, R&D Inc.

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Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc. Identifier: NCT00530062     History of Changes
Other Study ID Numbers: IXR-404-04-167
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Teva Pharmaceutical Industries ( Teva Branded Pharmaceutical Products, R&D Inc. ):
Asthma and Poor Coordinators of Asthma Inhalers
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action