A Study in Patients With Chronic Obstructive Pulmonary Disease
Study Identifier:
CCD-0910-PR-0021
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Chronic Obstructive Pulmonary Disease
Study Drug
- Drug: Beclomethasone Dipropionate - Formoterol
- Drug: Fluticasone - Salmeterol
Date
Apr 2011 - Mar 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 once applicable written informed consent obtained by legal representative.
- Outpatients with a diagnosis of 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.
- Use of bronchodilators in the previous 2 months to visit 1.
- Post-bronchodilator FEV1 \< 60% of the predicted normal value.
- Post-bronchodilator FEV1/FVC \< 0.7.
- A ≥ 5% response to a reversibility test.
- A Baseline Dyspnoea Index (BDI) focal score less or equal than 10 (to be met also at visit 2).
- History of no more than one COPD exacerbation in the previous 12 months (without considering the last 2 months) to visit 1.
- A cooperative attitude and ability to be trained to the proper use of pMDI and DPI (Accuhaler®, circular moulded plastic inhaler) inhalers.
- Main
Exclusion Criteria
- Diagnosis of asthma or respiratory disorders (other than COPD) which could interfere with data interpretation according to the investigator's opinion.
- Pregnant or lactating women. Females of childbearing potential without an efficient contraception UNLESS they met the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or were using one or more of the following acceptable methods of contraception:
- Surgical sterilization (e.g., bilateral tubal ligation, hysterectomy);
- Hormonal contraception (implantable, patch, oral, injectable);
- Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
- Continuous abstinence (e.g. nuns). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception. Reliable contraception should have been maintained throughout the study and for 30 days after study drug discontinuation.
- Clinical or functional unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. uncontrolled coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which could impact the evaluation of the results of the study according to investigator's judgement.
- Patient with narrow-angle glaucoma.
- Clinically significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which could impact the evaluation of the results of the study and the safety of the patient according to investigator's judgement.
- Patients with COPD exacerbation (see previous at inclusion criteria no. 3) in the 2 months prior to screening and during the study period.
- Patients requiring long term (\> 12 hours daily) oxygen therapy for chronic hypoxemia.
- Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.
- Patients with known allergy, sensitivity or intolerance to sympathomimetic drugs or inhaled corticosteroids or to any of the excipients contained in the study drugs.
- Patients who had evidence of alcohol or drug abuse, who were not compliant with the study protocol or not compliant with the study treatments according to investigator's judgement.
- Major surgery in the previous 3 months and during the trial which could affect patient's compliance in the study procedures (e.g. spirometry).
- Participation in another clinical trial with an investigational drug in the 2 months preceding visit 1.
- Patients requiring chronic mechanical ventilation for COPD
Healthy Volunteers
No
Protocol Summary
The primary objective of the study was to demonstrate the superiority of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), in terms of pulmonary function (AUC0-30min standardized by time of change from pre-dose in FEV1) after drug inhalation in the morning of day 1, and the equivalence between Foster® 100/6 (two puffs b.i.d.) and Seretide® 500/50 (one inhalation b.i.d.) in terms of Transition Dyspnoea Index (TDI) score at day 84 in patients with COPD.
The secondary objectives of the study were:
- To evaluate the efficacy of the test treatments in terms of additional spirometric parameters and of clinical outcome measures;
- To assess the safety and tolerability;
- To perform an exploratory analysis evaluating the consumption of resources deriving from COPD management in the perspective of the Healthcare System.
Study Locations
Location
Status
Location
Aarhus University Hospital
Aarhus, Denmark
Status
N/A
Location
Bispebjerg Hospital
Copenhagen, Denmark
Status
N/A
Location
Dept. of Cardiology and Respiratory Medicine
Copenhagen, Denmark
Status
N/A
Location
Gentofte Hospital
Gentofte Municipality, Denmark
Status
N/A
Location
Odense University Hospital
Odense, Denmark
Status
N/A
Location
Centre Hospitalier
Toulon, France
Status
N/A
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