CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 132 enrolled
Drug / intervention
Formoterol fumarate (6 μg) +4 moredrug
Likely dose
Formoterol fumarate (6 μg)from 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/NCT02796651
NCT02796651Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Incomplete Unbalanced, Crossover Study to Assess the Efficacy and Safety of Three Doses of Formoterol Fumarate in Pressair® Compared With Perforomist® Inhalation Solution (20 and 40 μg Open-label) in Moderate to Severe COPD Patients With Reversible Airway Disease.

AstraZeneca·interventional·Posted Jun 13, 2016·Updated Feb 7, 2018

In Brief

A Phase 2 clinical trial evaluating Formoterol fumarate (6 μg), Formoterol furmarate (20 μg), and 3 other interventions for Chronic Obstructive Pulmonary Disease - COPD. Completed, enrolled 132 participants across 20 sites.

Detailed Summary

To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease - COPD
CountriesUnited States
CollaboratorsParexel

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJun 13, 2016
Enrollment StartJun 30, 2016
Primary CompletionDec 7, 2016
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 10.1 years ago

Interventions

Formoterol fumarate (6 μg)drug

Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)

Formoterol furmarate (20 μg)drug

Oral Inhalation (via a standard jet nebulizer connected to an air compressor.

Placebo for formoterol fumaratedrug

Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)

Formoterol fumarate (12 μg)drug

Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)

Formoterol fumarate (40 μg)drug

Oral Inhalation (via a standard jet nebulizer connected to an air compressor.