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

Teva Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: Albuterol-HFA-MDI; Drug: Albuterol-HFA-BAI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530062

IXR-404-04-167

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 7 to 70 years old

Volunteers: No Healthy Volunteers

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
• Previous enrollment in an IVAX Research-sponsored Albuterol-HFA asthma study Note: Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Albuterol-HFA-BAI

Experimental group

Description:

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

Treatment:

Drug: Albuterol-HFA-BAI

Albuterol-HFA-MDI

Active Comparator group

Description:

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

Treatment:

Drug: Albuterol-HFA-MDI