Skip to main content
OpenTrials
Completed

NCT Number: NCT01245569

A Study in Patients With Chronic Obstructive Pulmonary Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Policlinico Umberto I - VIII Padiglione

Rome, 00161, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Foster® 100/6 µg/unit dose

Drug

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

Drug

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 outcomes

  1. Transition Dyspnoea Index (TDI) score

    Time frame: At day 84

  2. 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 outcomes

  1. Change from baseline in pre-dose morning Forced Expiratory Volume in one second (FEV1)

    Time frame: At each clinic visit

  2. 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

  3. Change from baseline in the St George's Respiratory Questionnaire (SGRQ)component and total scores

    Time frame: At day 84

  4. 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

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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

Acronym: FUTURE

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2010
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.