Status:
COMPLETED
A Study in Patients With Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief 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...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT01245569
Start Date
April 1 2011
End Date
March 1 2012
Last Update
March 30 2017
Active Locations (1)
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1
Policlinico Umberto I - VIII Padiglione
Rome, Rome, Italy, 00161