Back to resultsA Study in Patients With Chronic Obstructive Pulmonary Disease (FUTURE)
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Foster® 100/6 µg/unit dose
Seretide Accuhaler® 500/50 µg/actuation
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
- Policlinico Umberto I - VIII Padiglione
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Foster®
Seretide® Accuhaler®
Arm 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).
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).
Outcomes
Primary Outcome Measures
Transition Dyspnoea Index (TDI) score
Area Under the Curve (AUC) 0-30min standardized by time of change from pre-dose in Forced Expiratory Volume in one second (FEV1)
Secondary Outcome Measures
Change from baseline in pre-dose morning Forced Expiratory Volume in one second (FEV1)
Change from pre-dose in Forced Vital Capacity (FVC)
Change from baseline in the St George's Respiratory Questionnaire (SGRQ)component and total scores
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)
Full Information
NCT ID
NCT01245569
First Posted
November 19, 2010
Last Updated
March 28, 2017
Sponsor
Chiesi Farmaceutici S.p.A.
1. Study Identification
Unique Protocol Identification Number
NCT01245569
Brief Title
A Study in Patients With Chronic Obstructive Pulmonary Disease
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 treatment period in Chronic Obstructive Pulmonary Disease (COPD) patients.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
373 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Foster®
Arm Type
Experimental
Arm 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).
Arm Title
Seretide® Accuhaler®
Arm Type
Active Comparator
Arm 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).
Intervention Type
Drug
Intervention Name(s)
Foster® 100/6 µg/unit dose
Intervention 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).
Intervention Type
Drug
Intervention Name(s)
Seretide Accuhaler® 500/50 µg/actuation
Intervention 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).
Primary Outcome Measure Information:
Title
Transition Dyspnoea Index (TDI) score
Time Frame
At day 84
Title
Area Under the Curve (AUC) 0-30min standardized by time of change from pre-dose in Forced Expiratory Volume in one second (FEV1)
Time Frame
After drug inhalation in the morning of day 1
Secondary Outcome Measure Information:
Title
Change from baseline in pre-dose morning Forced Expiratory Volume in one second (FEV1)
Time Frame
At each clinic visit
Title
Change from pre-dose in Forced Vital Capacity (FVC)
Time Frame
At 5, 15, 30 min after drug intake, at day 1 and day 84
Title
Change from baseline in the St George's Respiratory Questionnaire (SGRQ)component and total scores
Time Frame
At day 84
Title
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)
Time Frame
At day 84
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dave Singh, MD
Organizational Affiliation
The Medicine Evaluation Unit - Manchester, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jorgen Vestbo, MD
Organizational Affiliation
Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico Umberto I - VIII Padiglione
City
Rome
ZIP/Postal Code
00161
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24621109
Citation
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 fluticasone/salmeterol combination therapy in COPD. BMC Pulm Med. 2014 Mar 12;14:43. doi: 10.1186/1471-2466-14-43.
Results Reference
result
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2009-014410-10
Description
Study Record on EU Clinical Trials Register including results
Learn more about this trial
A Study in Patients With Chronic Obstructive Pulmonary Disease
We'll reach out to this number within 24 hrs