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

Chiesi

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Seretide Accuhaler® 500/50 µg/actuation; Drug: Foster® 100/6 µg/unit dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01245569

2009-014410-10 (EudraCT Number)

CCD-0910-PR-0021

Details and patient eligibility

About

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.

Full 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 mortality and the 12th leading cause of morbidity world-wide. Furthermore, trends in the use of medical care resources indicate that the economic cost of COPD continues to rise in direct relation to the ageing population, the increase in prevalence of disease and the cost of new and existing medical and public health interventions.

Enrollment: 373 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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373 participants in 2 patient groups

Foster®

Experimental group

Description:

Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP "extrafine" 400 µg plus FF 24 µg).

Treatment:

Drug: Foster® 100/6 µg/unit dose

Seretide® Accuhaler®

Active Comparator group

Description:

Seretide® Accuhaler® (fluticasone 500 μg plus salmeterol 50 μg/actuation), 1 inhalation b.i.d. (daily dose of fluticasone 1000 μg plus salmeterol 100 μg).

Treatment:

Drug: Seretide Accuhaler® 500/50 µg/actuation