CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 22 enrolled
Drug / intervention
A006 DPI +4 moredrug
Likely dose
A006 DPI 110 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02210806
NCT02210806Phase 2Completed

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)

Amphastar Pharmaceuticals, Inc.·interventional·Posted Aug 7, 2014·Updated Apr 19, 2017

In Brief

A Phase 2 clinical trial evaluating A006 DPI, Placebo DPI, and 1 other intervention for Asthma. Completed, enrolled 22 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 7, 2014
Enrollment StartJul 1, 2014
Primary CompletionSep 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.9 years ago

Interventions

A006 DPIdrug

Single dose 110 mcg, 1 inhalation

A006 DPIdrug

Single dose 220 mcg, 1 inhalation

Placebo DPIother

Placebo, 1 inhalation

Proventil® MDIdrug

Single dose 90 mcg, 1 inhalation

Proventil® MDIdrug

Single dose 90 mcg, 2 inhalations