Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-25

Study Completion Date

2008-10-24

Brief Summary

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This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Albuterol-HFA-BAI

Participants will receive single actuation of albuterol 90 micrograms (mcg), administered using BAI in treatment period 1 or 2.

Group Type EXPERIMENTAL

Albuterol-HFA-BAI

Intervention Type DRUG

Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.

Albuterol-HFA-MDI

Participants will receive single actuation of albuterol 90 mcg, administered using MDI in treatment period 1 or 2.

Group Type ACTIVE_COMPARATOR

Albuterol-HFA-MDI

Intervention Type DRUG

Inhalation Aerosols, 90 mcg, 1 dose per treatment period

Interventions

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Albuterol-HFA-MDI

Inhalation Aerosols, 90 mcg, 1 dose per treatment period

Intervention Type DRUG

Albuterol-HFA-BAI

Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.

Intervention Type DRUG

Other Intervention Names

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Albuterol ProAir Albuterol

Eligibility Criteria

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Inclusion Criteria

* Asthma of a minimum of 6 months duration
* Participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the Aerosol Inhalation Monitor (AIM, Vitalograph) prior to any training and following training in 3 consecutive attempts
* 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 peak expiratory flow (PEF) determinations and report scores on diaries
* Can tolerate withdrawal of applicable medications for qualification at screening
* Otherwise healthy individuals
* Non-smokers for at least 2 years prior to the screening visit

Exclusion Criteria

* Allergy or sensitivity to albuterol
* Exposure to investigational drugs within 30 days prior to the screening visit
* Continuous treatment with beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids
* Treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit
* The prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit
* 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 3 months prior to the screening visit
* An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved 3 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

Minimum Eligible Age

7 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No