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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01245569
First received: November 19, 2010
Last updated: April 2, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Drug: Foster® 100/6 µg/unit dose
Drug: Seretide Accuhaler® 500/50 µg/actuation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Transition Dyspnoea Index (TDI) score [ Time Frame: At day 84 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in pre-dose morning Forced Expiratory Volume in one second (FEV1) [ Time Frame: At each clinic visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from baseline in the St George's Respiratory Questionnaire (SGRQ)component and total scores [ Time Frame: At day 84 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Foster®
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).
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).
Active Comparator: Seretide® Accuhaler®
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).
Drug: 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).

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245569

Locations
Italy
Policlinico Umberto I - VIII Padiglione
Rome, Italy, 00161
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Dave Singh, MD The Medicine Evaluation Unit - Manchester, UK
Principal Investigator: Jorgen Vestbo, MD Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark
  More Information

No publications provided by Chiesi Farmaceutici S.p.A.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier: NCT01245569     History of Changes
Other Study ID Numbers: CCD-0910-PR-0021, 2009-014410-10
Study First Received: November 19, 2010
Last Updated: April 2, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Turkey: Ministry of Health
Denmark: Danish Medicines Agency
Italy: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Fluticasone
Beclomethasone
Fluticasone, salmeterol drug combination
Formoterol
Salmeterol
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on July 23, 2014