CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
Albuterol DPI 25 mcg/inh +3 moredrug
Likely dose
Albuterol DPI 25 mcg/inhfrom 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/NCT01581177
NCT01581177Phase 2Completed
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A Randomized, Double- or Evaluator-blind, Active- and Placebo-controlled, Single Dose, Seven-arm, Crossover Dose-ranging Study of A006 in Adult Asthma Patients

Amphastar Pharmaceuticals, Inc.·interventional·Posted Apr 20, 2012·Updated May 19, 2017

In Brief

A Phase 2 clinical trial evaluating Albuterol DPI 25 mcg/inh, Albuterol DPI 90 mcg/inh, and 2 other interventions for Asthma. Completed, enrolled 23 participants across 4 sites.

Detailed 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.

Study Details

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

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2012
Enrollment StartApr 1, 2012
Primary CompletionJul 1, 2012
Study CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 14.2 years ago

Interventions

Albuterol DPI 25 mcg/inhdrug

Albuterol DPI with 25 mcg Albuterol/inhalation

Albuterol DPI 90 mcg/inhdrug

Albuterol DPI with 90 mcg Albuterol/inhalation

Placebo DPIdrug

Placebo DPI with 0 mcg Albuterol/inhalation

Albuterol MDI 90 mcg/inhdrug

Albuterol MDI with 90 mcg Albtuerol/inhalation