NCT00605891

Dose Finding Study of CHF 4226 for Treating Patients With COPD

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
DRUG	carmoterol (CHF 4226)	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)
DRUG	carmoterol (CHF 4226)	carmoterol pMDI 1.0 μg once a day, in the morning (1 puff of carmoterol 1.0 mcg + 1 puff of placebo pMDI))
DRUG	carmoterol (CHF 4226)	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)
DRUG	salmeterol	Salmeterol 50 μg DPI, in the morning and in the evening (1 blister BID)
DRUG	placebo	Placebo pMDI once a day, in the morning (1 puff of placebo pMDI + 1 puff of placebo pMDI)

Timeline

• Start date: 2006-10-01
• Primary completion: 2007-06-01
• Completion: 2007-06-01
• First posted: 2008-01-31
• Last updated: 2017-04-11

Locations

50 sites across 6 countries: United States, Czechia, Germany, Poland, Romania, South Africa