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EFFICACY AND TOLERABILITY OF BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg pMDI VIA HFA-134a vs. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI

NCT00394368 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2020-08-03

No results posted yet for this study

Summary

The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of fluticasone/salmeterol pMDI in patients with moderate to severe asthma

Conditions

  • Bronchial Asthma

Interventions

DRUG

beclomethasone dipropionate plus formoterol fumarate combination

DRUG

fluticasone propionate plus salmeterol xinafoate combination

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Leonardo M. Fabbri, MD · Department of Respiartory Diseases - University of Modena and Reggio Emilia, Modena, Italy

  • Maurizio A. Vignola, MD · Institute of Lung Pathophysiology, National Research Council, Palermo, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-11-30
Completion
2005-09-30

Countries

  • Poland
  • Ukraine

Study Locations

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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 NCT00394368 on ClinicalTrials.gov