A Study in Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

— FUTURE  

Official title:

A 12-week, Multicentre, Multinational, Randomized, Double-blind, Double-dummy, 2-arm Parallel Group Study Comparing the Efficacy and Safety of Foster® 100/6 (Beclomethasone Dipropionate 100 µg Plus Formoterol 6 µg/Actuation), 2 Puffs b.i.d., Versus Seretide® 500/50 (Fluticasone 500 µg Plus Salmeterol 50 µg/Actuation), 1 Inhalation b.i.d., in Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01245569
• Other study ID #: CCD-0910-PR-0021
• Secondary ID: 2009-014410-10
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2010
• Last updated: March 28, 2017
• Start date: April 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2017
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Foster® 100/6 µg/unit dose
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).
• Seretide Accuhaler® 500/50 µg/actuation
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).

Locations

Country	Name	City	State
Italy	Policlinico Umberto I - VIII Padiglione	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Singh D, Nicolini G, Bindi E, Corradi M, Guastalla D, Kampschulte J, Pierzchala W, Sayiner A, Szilasi M, Terzano C, Vestbo J; FUTURE (Foster Upgrades TherapeUtic care in REspiratory disease) study group.. Extrafine beclomethasone/formoterol compared to fl — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transition Dyspnoea Index (TDI) score		At day 84
Primary	Area Under the Curve (AUC) 0-30min standardized by time of change from pre-dose in Forced Expiratory Volume in one second (FEV1)		After drug inhalation in the morning of day 1
Secondary	Change from baseline in pre-dose morning Forced Expiratory Volume in one second (FEV1)		At each clinic visit
Secondary	Change from pre-dose in Forced Vital Capacity (FVC)		At 5, 15, 30 min after drug intake, at day 1 and day 84
Secondary	Change from baseline in the St George's Respiratory Questionnaire (SGRQ)component and total scores		At day 84
Secondary	Change from baseline in pre-dose and in post-dose distance walked (6 Minute Walking Test - 6MWT) (in a subset of at least 50 % of patients from pre-selected sites)		At day 84

External Links

•   Study Record on EU Clinical Trials Register including results