NCT01581177

Albuterol DPI (A006) Clinical Study-B2: Efficacy, Dose-Ranging and Initial Safety Evaluation

A Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Crossover Dose-ranging Study of A006 in Adult Asthma Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Amphastar Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dosing in comparison to a DPI Placebo Control and an Albuterol metered dose inhaler (MDI) Active Control. This study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma for at least 6 months, but are otherwise generally healthy.

Detailed description

The main objective of this study is to evaluate the efficacy, dose-ranging and initial safety profiles of A006, an Albuterol dry powder inhaler (DPI), in the dose range of 25 to 180 mcg per dose in comparison to the DPI Placebo Control and the Active (Reference) Control. The study results of this study together with that of A006-B study will be utilized to determine the optimum final dose range of A006 for further clinical studies. The study will be conducted in male and female adult patients who have mild-to-moderate persistent asthma but are otherwise generally healthy.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Albuterol DPI 25 mcg/inh	Albuterol DPI with 25 mcg Albuterol/inhalation
DRUG	Albuterol DPI 90 mcg/inh	Albuterol DPI with 90 mcg Albuterol/inhalation
DRUG	Placebo DPI	Placebo DPI with 0 mcg Albuterol/inhalation
DRUG	Albuterol MDI 90 mcg/inh	Albuterol MDI with 90 mcg Albtuerol/inhalation

Timeline

• Start date: 2012-04-01
• Primary completion: 2012-07-01
• Completion: 2012-08-01
• First posted: 2012-04-20
• Last updated: 2017-05-19

Locations

4 sites across 1 country: United States