- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01351792
A Study in Patients With Chronic Obstructive Pulmonary Disease (FAIR) (FAIR)
March 28, 2017 updated by: Chiesi Farmaceutici S.p.A.
A 12-week, Multicentre, Randomised, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® 100/6 (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Puffs b.i.d., Versus Symbicort® 200/6 (Budesonide 200 µg Plus Formoterol 6 µg/Actuation), 2 Inhalations b.i.d., on Parameters of Small Airway Function in Patients With Chronic Obstructive Pulmonary Disease.
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Chronic obstructive pulmonary disease (COPD) is an incurable, debilitating and progressive disease that can be fatal.
The recent Global Burden of Disease Study ranks COPD as the 6th leading cause of mortality and the 12th leading cause of morbidity world-wide.
Furthermore, trends in the use of medical care resources indicate that the economic cost of COPD continues to rise in direct relation to the ageing population, the increase in prevalence of disease and the cost of new and existing medical and public health interventions.
Study Type
Interventional
Enrollment (Actual)
113
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Groningen, Netherlands, 9713
- Department of Pulmonary Diseases - University Medical Center Groningen
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or when applicable written informed consent obtained by legal representative.
Outpatients with a clinical diagnosis of moderate to severe COPD and including:
- Smoking history of at least 10 pack years defined as [(number of cigarettes smoked per day) x (number of years of smoking)] / 20, both current and ex-smokers are eligible.
- Regular use of bronchodilators (e.g. β2-agonist, anticholinergics) in the 2 months before visit 1.
- Post-bronchodilator FEV1 < 65% of the predicted normal value at visit 1.
- Post-bronchodilator FEV1/FVC < 0.7 at visit 1.
- An increase in FEV1 < 15% and < 200 mL from baseline following administration of 400 µg of salbutamol at visit 1.
- Plethysmographic Functional Residual Capacity (FRC) > 120% of the predicted normal value (at visit 1 and visit 2).
- A Baseline Dyspnoea Index (BDI) focal score less or equal to 10 (at visit 1 and at visit 2).
- A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Turbohaler®, inspiratory flow-driven, multidose powder inhaler) inhalers.
Main Exclusion Criteria:
- Diagnosis of asthma or other clinically or functionally relevant respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator's opinion.
- Clinically unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which may impact the evaluation of the results of the study according to investigator's judgement.
- Patients with COPD exacerbation and/or symptomatic infection of the airways requiring antibiotic therapy (at least 5 days) in the 2 months prior to screening and during the study period.
- Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.
- Major surgery in the previous 3 months and during the trial which may affect patient's compliance in study procedures (e.g. plethysmography).
- Patients requiring chronic mechanical ventilation for COPD.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Foster®
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).
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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).
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Active Comparator: Symbicort® Turbohaler®
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).
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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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline to end of treatment in post-dose residual volume.
Time Frame: At day 84
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At day 84
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes from baseline in FEV1, FVC, FEV1/FVC, IVC/FVC, RV, TLC, RV/TLC, FRC, FRC/TLC, RV/VC, Raw, eff and sGaw, eff.
Time Frame: At day 84
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At day 84
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Changes from baseline in airways resistance (R5, R20, R5-20) and reactance at 5 Hertz (X5) (in a subset of at least 50% of patients from pre-selected sites);
Time Frame: at day 84
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at day 84
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Changes from baseline in COPD symptom scores (for each single score and the total score);
Time Frame: At day 84
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At day 84
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Change from baseline in percentage of COPD symptom-free days;
Time Frame: At day 84
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At day 84
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Change from baseline in rescue salbutamol or ipratropium bromide consumption (puffs per day);
Time Frame: At day 84
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At day 84
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Change from baseline in percentage of rescue salbutamol or ipratropium bromide-free days;
Time Frame: At day 84
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At day 84
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Transition Dyspnoea Index (TDI) score;
Time Frame: At day 84 (V4)
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At day 84 (V4)
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Clinical COPD Questionnaire (CCQ);
Time Frame: At screening (day -28), at baseline (day 0) and at the end of trial (day 84)
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At screening (day -28), at baseline (day 0) and at the end of trial (day 84)
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Physical activity (by means of pedometer);
Time Frame: Each day of the two weeks before each clinic visit
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Each day of the two weeks before each clinic visit
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Nasal brushing (mRNA expression);
Time Frame: At screening (day -28), at baseline (day 0) and at the end of trial (day 84)
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At screening (day -28), at baseline (day 0) and at the end of trial (day 84)
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Number of patients with COPD exacerbations.
Time Frame: From pre-screening (day -35) to the end of trial (day 84)
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From pre-screening (day -35) to the end of trial (day 84)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Dirkje Postma, MD, Dept. of Pulmonary Medicine and Tuberculosis - University of Groningen - The Netherlands
- Principal Investigator: Marteen van den Berge, MD, Dept. of Pulmonary Medicine and Tuberculosis - University of Groningen - The Netherlands
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Faiz A, Imkamp K, van der Wiel E, Boudewijn IM, Koppelman GH, Brandsma CA, Kerstjens HAM, Timens W, Vroegop S, Pasma HR, Boersma WG, Wielders P, van den Elshout F, Mansour K, Steiling K, Spira A, Lenburg ME, Heijink IH, Postma DS, van den Berge M. Identifying a nasal gene expression signature associated with hyperinflation and treatment response in severe COPD. Sci Rep. 2020 Oct 15;10(1):17415. doi: 10.1038/s41598-020-72551-0.
- Boudewijn IM, Faiz A, Steiling K, van der Wiel E, Telenga ED, Hoonhorst SJM, Ten Hacken NHT, Brandsma CA, Kerstjens HAM, Timens W, Heijink IH, Jonker MR, de Bruin HG, Sebastiaan Vroegop J, Pasma HR, Boersma WG, Wielders P, van den Elshout F, Mansour K, Spira A, Lenburg ME, Guryev V, Postma DS, van den Berge M. Nasal gene expression differentiates COPD from controls and overlaps bronchial gene expression. Respir Res. 2017 Dec 21;18(1):213. doi: 10.1186/s12931-017-0696-5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
November 1, 2012
Study Registration Dates
First Submitted
May 10, 2011
First Submitted That Met QC Criteria
May 10, 2011
First Posted (Estimate)
May 11, 2011
Study Record Updates
Last Update Posted (Actual)
March 30, 2017
Last Update Submitted That Met QC Criteria
March 28, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCD-1007-PR-0045
- 2010-022895-30 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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