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: Foster® 100/6 µg/unit dose
- Drug: Seretide Accuhaler® 500/50 µg/actuation
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
- Clinically relevant respiratory disorders.
- Current diagnosis of asthma or respiratory disorders other than COPD.
- Clinically significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which may impact the feasibility of the results of the study according to investigator's judgement.
- Patients with COPD exacerbation in the 2 months prior to screening and during the study period.
- Patients requiring long term (at least 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.
Healthy Volunteers
No
Protocol Summary
The purpose of the present study is to determine the effects on health status and spirometric values of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), over a 12-week treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.
Study Locations
Location
Status
Location
Policlinico Umberto I - VIII Padiglione
Rome, Rome, Italy, 00161
Status
N/A