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Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. (Symbicort®)

NCT00413387 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 219

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 budesonide/formoterol dry powder via Turbuhaler.

Conditions

  • Bronchial Asthma

Interventions

DRUG

beclomethasone dipropionate plus formoterol fumarate combination

100mcg beclomethasone diproprionate plus 6 mcg formoterol

DRUG

budesonide plus formoterol combination

200mcg budesonide plus 6 mcg formoterol

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Leonardo M. Fabbri, MD · Department of Resipiratory 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
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2005-08-31
Completion
2005-10-31

Countries

  • Austria
  • 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 NCT00413387 on ClinicalTrials.gov