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FACTO Study (Foster® As Complete Treatment Option)

NCT00901368 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 431

Last updated 2017-03-30

No results posted yet for this study

Summary

Double blind, multinational, multicentre, randomised, 2 arm parallel group study

Conditions

  • Asthmatic Patients

Interventions

DRUG

FOSTER

CHF1535 (beclometasone dipropionate 100 µg plus formoterol 6 µg) pMDI aerosol via HFA-134a propellant 2 inhalations b.i.d. (daily dose 400 µg + 24µg)

DRUG

Seretide

Fluticasone 250 µg + salmeterol 50 µg DPI (Seretide® Diskus®) 1 inhalation b.i.d. (daily dose 500+100 µg)

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Neil Barnes, MD · Department ofRespiratory Medicine, London Chest Hospital, Barts& The London NHS Trust,Bonner Road, E2 9JX, London (UK)

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
2009-05-31
Primary Completion
2010-09-30
Completion
2010-12-31

Countries

  • France
  • Germany
  • Netherlands
  • Spain

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 NCT00901368 on ClinicalTrials.gov