NCT01174732

Dose-Ranging Study of A006 DPI, in Adult Asthma Patients

Phase II Study Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Cross-over and Dose-ranging Study of A006 DPI, Albuterol Inhalation Powder, in Adult Asthma Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Amphastar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is a randomized, active- and placebo-controlled, single-dose, seven-arm, crossover and dose-ranging design. This study aims to evaluate the efficacy and initial safety profiles, and to identify the optimum dose of A006, from a select dose-range for future clinical PK/PD and Phase III studies. This study is to be conducted in generally healthy, adult subjects who have mild-to-moderate persistent asthma for at least 6 months prior to Screening.

Conditions

• Asthma
• Bronchospasm

Interventions

Type	Name	Description
DRUG	albuterol inhalation powder	A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation
DRUG	albuterol inhalation powder	A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation
DRUG	albuterol inhalation powder	A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
DRUG	albuterol inhalation powder	A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations
DRUG	Placebo	placebo, lactose inhalation carrier
DRUG	albuterol inhalation aerosol	albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations
DRUG	albuterol inhalation aerosol	albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-10-01
• Completion: 2011-01-01
• First posted: 2010-08-04
• Last updated: 2017-04-19

Locations

4 sites across 1 country: United States