A Study in Patients With Chronic Obstructive Pulmonary Disease (FAIR)
Study Identifier:
CCD-1007-PR-0045
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Study Contact Information:
N/A
Terminated/Withdrawn
Study Details
Medical Condition
- Chronic Obstructive Pulmonary Disease
Study Drug
- Drug: Foster® 100/6 µg/unit dose
- Drug: Symbicort® Turbohaler® 200/6 μg/actuation
Date
Sep 2011 - Nov 2012
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40+ years
Requirements Information
Inclusion and Exclusion Criteria
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.
Healthy Volunteers
No
Protocol 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.
Study Locations
Location
Status
Location
Department of Pulmonary Diseases - University Medical Center Groningen
Groningen, Netherlands, 9713
Status
N/A
Study 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.