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

Asthma Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02210806
Study type Interventional
Source Amphastar Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 2
Start date July 2014
Completion date October 2014
View Details
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