CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 109 enrolled
Drug / intervention
Formoterol +2 moredrug
Likely dose
Formoterol 9 μgfrom 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/NCT01048333
NCT01048333Phase 2Completed

A Randomised, Placebo-controlled, Double-blind (Double-dummy Technique),Crossover, Multi-centre Study, to Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler® 9 μg, Compared With Serevent® Diskus® 50 μg.

AstraZeneca·interventional·Posted Jan 13, 2010·Updated Oct 25, 2012

In Brief

A Phase 2 clinical trial evaluating Formoterol, Salmeterol, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 109 participants across 17 sites in 3 countries.

Detailed Summary

* Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose. * Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly, Spain, Sweden
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2010
Enrollment StartJan 1, 2010
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.5 years ago

Interventions

Formoteroldrug

Formoterol Turbuhaler 9 μg and Placebo Diskus

Salmeteroldrug

Salmeterol Diskus 50 μg and Placebo Turbuhaler

Placebodrug

Placebo Diskus and Placebo Turbuhaler