A Study in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Formoterol Fumarate; Salmeterol Xinafoate

Criteria

Inclusion Criteria:

1. 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.

2. Outpatients with a diagnosis of COPD and including:

1. 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.

2. Use of bronchodilators in the previous 2 months to visit 1.

3. Post-bronchodilator FEV1 < 60% of the predicted normal value.

4. Post-bronchodilator FEV1/FVC < 0.7.

5. A ≥ 5% response to a reversibility test.

6. A Baseline Dyspnoea Index (BDI) focal score less or equal than 10 (to be met also at visit 2).

3. History of no more than one COPD exacerbation in the previous 12 months (without considering the last 2 months) to visit 1.

4. 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:

1. Clinically relevant respiratory disorders.

2. Current diagnosis of asthma or respiratory disorders other than COPD.

3. 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.

4. Patients with COPD exacerbation in the 2 months prior to screening and during the study period.

5. Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia.

6. Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period.