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A Study in Patients With Chronic Obstructive Pulmonary Disease (FAIR)

NCT01351792 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2017-03-30

No results posted yet for this study

Summary

The purpose of the present study is to demonstrate the higher efficacy of small particles Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations b.i.d.), in terms of residual volume reduction over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.

Conditions

Interventions

DRUG

Foster® 100/6 µg/unit dose

Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP "extrafine" 400 µg plus FF 24 µg).

DRUG

Symbicort® Turbohaler® 200/6 μg/actuation

Symbicort® Turbohaler® (budesonide 200 μg plus formoterol fumarate 6 μg/actuation), 2 inhalations b.i.d. (daily dose of BUD 800 μg plus FF 24 μg).

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Dirkje Postma, MD · Dept. of Pulmonary Medicine and Tuberculosis - University of Groningen - The Netherlands

  • Marteen van den Berge, MD · Dept. of Pulmonary Medicine and Tuberculosis - University of Groningen - The Netherlands

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Netherlands

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 NCT01351792 on ClinicalTrials.gov