CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
A006 +2 moredrug
Likely dose
A006 180 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/NCT01189396
NCT01189396Phase 2Completed
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A Randomized, Double- or Evaluator-blinded, Active- and Placebo-controlled, Cumulative-dose, Dose-escalating, Three-arm, Cross-over Study, in 24 Asthma Patients

Amphastar Pharmaceuticals, Inc.·interventional·Posted Aug 26, 2010·Updated Jul 2, 2017

In Brief

A Phase 2 clinical trial evaluating A006, Placebo DPI, and 1 other intervention for Asthma and 2 related conditions. Completed, enrolled 27 participants across 4 sites.

Detailed Summary

The main objective is to evaluate the bronchodilatory efficacy, safety and pharmacokinetic profiles of A006 (Albuterol Dry Powder Inhaler (DPI)), in comparison with those of an active control, Proventil-HFA (Albuterol Metered Dose Inhaler (MDI)), and a Placebo DPI in escalating and cumulative-doses up to 1440 mcg, eight (8) times of the proposed clinical dose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma, Bronchospasm, Chronic Obstructive Pulmonary Disease (COPD)
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 26, 2010
Enrollment StartJul 1, 2010
Primary CompletionDec 1, 2010
Study CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.8 years ago

Interventions

A006drug

Albuterol DPI with 180 mcg Albuterol/inhalation

Placebo DPIdrug

Placebo DPI with 0 mcg Albuterol/inhalation

Proventil-HFAdrug

Albuterol MDI with 90 mcg Albuterol/inhalation