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.

First Received on September 14, 2007. Last Updated on December 12, 2011 History of Changes

Sponsor:	Teva Branded Pharmaceutical Products, R&D Inc.
Information provided by (Responsible Party):	Teva Branded Pharmaceutical Products, R&D Inc.
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:	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:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate HFA 227

U.S. FDA Resources

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

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 February 12, 2012