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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

Information source: Teva Branded Pharmaceutical Products, R&D Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Albuterol-HFA-MDI (Drug); Albuterol-HFA-BAI (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Teva Branded Pharmaceutical Products, R&D Inc.

Official(s) and/or principal investigator(s):
Clinical Study Leader, Study Chair, Affiliation: Teva Branded Pharmaceutical Products, R&D Inc.

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.

Clinical Details

Official title: Comparison of Single-Dose Efficacy of Albuterol-HFA-BAI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The percent change in the area-under-the-effect curve from test day baseline FEV1 versus time

Secondary outcome:

The maximum percent increase in FEV1 (%) from baseline within the scheduled first 30 minutes of spirometric evaluations post dose

The maximum percent increase in FEV1 from baseline over 2 hours

The area-under-the-effect curve of change in FEV1 from test-day baseline versus time

Eligibility

Minimum age: 7 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Clinical Study Site, Huntington Beach, California 92647, United States

Teva Clinical Study Site, Lakewood, Colorado 80401, United States

Clinical Study Site, Minneapolis, Minnesota 55402, United States

Clinical Study Site, Oklahoma City, Oklahoma 73120, United States

Clinical Study Site, Lake Oswego, Oregon 97035, United States

Additional Information

Starting date: January 2007
Last updated: December 12, 2011

Page last updated: August 23, 2015

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