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Dose Finding Study of CHF 4226 for Treating Patients With COPD

NCT00605891 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 278

Last updated 2017-04-11

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Chiesi USA, Inc.

    collaborator INDUSTRY

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Barry Make, MD · National Jewish Medical & Research Center

  • Steven E Linberg, Ph.D. · Chiesi Farmaceutici S.p.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2007-06-30
Completion
2007-06-30

Countries

  • United States
  • Czechia
  • Germany
  • Poland
  • Romania
  • South Africa

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00605891 on ClinicalTrials.gov