drugset / Trial / NCT01174732

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

NCT01174732

Phase 2 Completed 26 enrolled Amphastar Pharmaceuticals, Inc.
RandomizedCrossoverTriple-blindTreatment

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.

Timeline

Start
2010-07
Primary completion
2010-10
Completion
2011-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Salbutamol Unknown 90 ug Inhaled
Subject Salbutamol Unknown 120 ug Inhaled
Subject Salbutamol Unknown 180 ug Inhaled

Indications