Comparison of Single-Dose Efficacy of an Albuterol Breath Activated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered Dose Inhaler (HFA-MDI) (Both Using the Same Hydrofluoroalkane Propellant) in Asthmatics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier:
NCT00530062
First received: September 14, 2007
Last updated: December 12, 2011
Last verified: December 2011
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Teva Branded Pharmaceutical Products, R&D Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The maximum percent increase in FEV1 from baseline over 2 hours [ Time Frame: Baseline to two hours post dose, Study days 1 and 2 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: January 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
  • Other criteria apply
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530062

Locations
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.
Investigators
Study Chair: Clinical Study Leader Teva Branded Pharmaceutical Products, R&D Inc.
  More Information

No publications provided

Responsible Party: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov Identifier: NCT00530062     History of Changes
Other Study ID Numbers: IXR-404-04-167
Study First Received: September 14, 2007
Last Updated: December 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Branded Pharmaceutical Products, R&D Inc.:
Asthma and Poor Coordinators of Asthma Inhalers

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 20, 2014