A Study in Patients With Chronic Obstructive Pulmonary Disease (FAIR)

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Formoterol Fumarate

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 when applicable written informed consent obtained by legal representative.

2. Outpatients with a clinical diagnosis of moderate to severe 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. Regular use of bronchodilators (e.g. β2-agonist, anticholinergics) in the 2 months before visit 1.

3. Post-bronchodilator FEV1 < 65% of the predicted normal value at visit 1.

4. Post-bronchodilator FEV1/FVC < 0.7 at visit 1.

5. An increase in FEV1 < 15% and < 200 mL from baseline following administration of 400 µg of salbutamol at visit 1.

6. Plethysmographic Functional Residual Capacity (FRC) > 120% of the predicted normal value (at visit 1 and visit 2).

7. A Baseline Dyspnoea Index (BDI) focal score less or equal to 10 (at visit 1 and at visit 2).

3. 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:

1. 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.

2. 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.

3. 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.

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

5. Major surgery in the previous 3 months and during the trial which may affect patient's compliance in study procedures (e.g. plethysmography).

6. Patients requiring chronic mechanical ventilation for COPD.