CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 278 enrolled
Drug / intervention
carmoterol (CHF 4226) +4 moredrug
Likely dose
carmoterol (CHF 4226) 2.0 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/NCT00605891
NCT00605891Phase 2Completed
CompareCT.gov

A Randomized, Controlled,14-Treatment Day, Multicenter Study to Determine the Optimal Efficacious and Safe Dose of CHF 4226 in a Metered Dose Inhaler in Treating Patients With Chronic Obstructive Pulmonary Disease

Chiesi Farmaceutici S.p.A.·interventional·Posted Jan 31, 2008·Updated Apr 11, 2017

In Brief

A Phase 2 clinical trial evaluating carmoterol (CHF 4226), salmeterol, and 1 other intervention for Chronic Obstructive Pulmonary Disease. Completed, enrolled 278 participants across 50 sites in 6 countries.

Detailed Summary

The purpose of this study is to identify the optimal once-daily dose of CHF 4226 to be further developed for the treatment of patients with COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesCzechia, Germany, Poland, Romania, South Africa, United States
CollaboratorsChiesi USA, Inc.

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 31, 2008
Enrollment StartOct 1, 2006
Primary CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.4 years ago

Interventions

carmoterol (CHF 4226)drug

carmoterol pMDI 2.0 μg once a day, in the morning (1 puff of carmoterol 1.0 mcg + 1 puff of carmoterol 1.0 mcg)

carmoterol (CHF 4226)drug

carmoterol pMDI 1.0 μg once a day, in the morning (1 puff of carmoterol 1.0 mcg + 1 puff of placebo pMDI))

carmoterol (CHF 4226)drug

carmoterol pMDI 4.0 μg once a day, in the morning (1 puff of carmoterol 2.0 mcg + 1 puff of carmoterol 2.0 mcg)

salmeteroldrug

Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID)

placebodrug

Placebo pMDI once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)