Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique

Teva Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Asthma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00054964

IXR-202-4-167

Details and patient eligibility

About

This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler.

Full description

This was a single-center, randomized, open-label, active-controlled, 2-period, 2-sequence, single dose-dose, crossover comparison of the ability of Albuterol BOI-HFA to produce bronchodilation relative to that produced by to albuterol MDI-HFA in at least 12 asthmatics with poor inhaler coordinating ability.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asthma diagnosed ≥6 months prior and stable for 4 weeks prior to screening
• Poor inhaler coordination as assessed at screening
• Reversible bronchoconstriction (≥ 12% increase in FEV1)

Exclusion criteria

• Albuterol allergy
• Investigational drug within 30 days
• Injected corticosteroid within 6 weeks
• Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, long-acting beta-blockers, steroids other than those inhaled
• Other criterial apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Albuterol HFA-BOI

Experimental group

Treatment:

Drug: Albuterol HFA-BOI

Albuterol HFA-MDI

Active Comparator group

Treatment:

Drug: Albuterol HFA-MDI