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Efficacy and Tolerability of Beclomethasone Plus Salbutamol in HFA pMDI Fixed Combination vs Beclomethasone Plus Salbutamol in CFC pMDI Fixed Combination in a 12-week Treatment Period of Adult Patients With Uncontrolled Asthma

NCT00528723 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2017-03-30

No results posted yet for this study

Summary

The purpose of this trial is to verify if the test treatment BDP 250 mcg/salbutamol 100 mcg HFA pMDI fixed combination is non-inferior to BDP 250 mcg/salbutamol 100 mcg pMDI fixed combination given with the conventional CFC propellant (Clenil® Compositum 250, Chiesi Farmaceutici) in terms of Pulmonary Function (morning PEF).

Conditions

  • Bronchial Asthma

Interventions

DRUG

salbutamol 100 mcg

To be used as needed for symptom relief

DRUG

BDP/salbutamol HFA pMDI

Patients assigned to BDP/salbutamol HFA pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative CFC placebo

DRUG

BDP/salbutamol CFC pMDI

Patients assigned to BDP/salbutamol CFC pMDI will receive 2 puffs twice daily (morning and evening), for a total daily dose of BDP 1000 mcg/salbutamol 400 mcg, plus 2 puffs twice daily of alternative HFA placebo

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Giovanni Cremonesi, M D · Chiesi Farmaceutici S.p.A.

  • Gabriele Nicolini, CPM · Chiesi Farmaceutici S.p.A.

  • Luis Puente, Dr · Hospital General Universitario Gregorio Maranon, Madrid

  • Giorgio Walter Canonica, Prof. · Ospedale S.Martino e Cliniche Universitarie Convenzionate, Genova, Italy

  • Igor Bereznyakov, Prof. · Department of therapy of Kharkov Academy of Postgraduate Education, Kharkov, Ukraine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • Italy
  • Russia
  • Spain
  • 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 NCT00528723 on ClinicalTrials.gov