NCT02210806

Albuterol DPI (A006) Clinical Study-B3:Efficacy, Dose-ranging and Safety Evaluation

Efficacy, Dose-ranging and Safety Evaluation (A Randomized, Double- or Evaluator-blinded, Active- and Placebo-controlled, Single Dose, Five-arm, Crossover, and Dose-ranging Study of A006 in Adult Asthma Patients)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Amphastar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the efficacy, dose-ranging and safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 110 to 220 mcg per dose in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control.

Detailed description

This study is designed to evaluate the efficacy and safety profiles of A006 and to assist in identifying the optimum dose of A006 for future clinical studies. Proventil® HFA MDI, a currently marketed Albuterol MDI product, will be used as an Active Control. The study also employs a Placebo Control DPI, which has the same configuration as the A006 DPI except that it contains no active ingredient.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	A006 DPI	Single dose 110 mcg, 1 inhalation
DRUG	A006 DPI	Single dose 220 mcg, 1 inhalation
OTHER	Placebo DPI	Placebo, 1 inhalation
DRUG	Proventil® MDI	Single dose 90 mcg, 1 inhalation
DRUG	Proventil® MDI	Single dose 90 mcg, 2 inhalations

Timeline

• Start date: 2014-07-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2014-08-07
• Last updated: 2017-04-19

Locations

4 sites across 1 country: United States