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Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD

NCT00476099 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 828

Last updated 2021-10-29

No results posted yet for this study

Summary

To evaluate the 1-year efficacy and safety of the fixed combination beclometasone/formoterol pMDI in a twice daily regimen in patients with stable severe COPD.

Conditions

Interventions

DRUG

Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI

Beclomethasone 100 µg plus formoterol 6 µg (CHF1535) two puffs via oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.

DRUG

Budesonide 200 µg plus formoterol 6 µg DPI

two oral inhalations twice a day at 8.00 a.m. and 8.00 p.m.

DRUG

Formoterol 12 µg DPI

one oral inhalation twice a day at 8.00 a.m. and 8.00 p.m.

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Peter M.A. Calverley, Professor · Department of Medicine, Clinical Sciences Center University Hospital Aintree, Liverpool, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-08-31
Completion
2008-11-30

Countries

  • France

Study Locations

More Related Trials

Entities

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 NCT00476099 on ClinicalTrials.gov