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AzTrials

Chronic Obstructive Pulmonary DiseasePhase 3FUTURENCT01245569

A Study in Patients With Chronic Obstructive Pulmonary Disease

A Phase 3 study testing Beclomethasone Dipropionate - Formoterol and Fluticasone - Salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 68 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study was to demonstrate the superiority of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), in terms of pulmonary function (AUC0-30min standardized by time of change from pre-dose in FEV1) after drug inhalation in the morning of day 1, and the equivalence… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Beclomethasone Dipropionate - Formoterol and Fluticasone - Salmeterol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
419 participants
Where
68 sitesin 10 countries
Study dates
12 Apr 2011to 13 Mar 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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:
  • Diagnosis of asthma or respiratory disorders (other than COPD) which could interfere with data interpretation according to the investigator's opinion.
  • Pregnant or lactating women. Females of childbearing potential without an efficient contraception UNLESS they met the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or were using one or more of the following acceptable methods of contraception:
  • Surgical sterilization (e.g., bilateral tubal ligation, hysterectomy);
  • Hormonal contraception (implantable, patch, oral, injectable);
  • Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository.
  • Continuous abstinence (e.g. nuns). Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception. Reliable contraception should have been maintained throughout the study and for 30 days after study drug discontinuation.
  • Clinical or functional unstable concurrent disease: e.g. hyperthyroidism, diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease (e.g. uncontrolled coronary artery disease, hypertension, heart failure); gastrointestinal disease (e.g. active peptic ulcer); neurological disease; haematological disease; autoimmune disorders, or other which could impact the evaluation of the results of the study according to investigator's judgement.
  • Patient with narrow-angle glaucoma.
  • Clinically significant laboratory and ECG abnormalities indicating a significant or unstable concomitant disease which could impact the evaluation of the results of the study and the safety of the patient according to investigator's judgement.
  • Patients with COPD exacerbation (see previous at inclusion criteria no. 3) in the 2 months prior to screening and during the study period.
  • Patients requiring long term (> 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.
  • Patients with known allergy, sensitivity or intolerance to sympathomimetic drugs or inhaled corticosteroids or to any of the excipients contained in the study drugs.
  • Patients who had evidence of alcohol or drug abuse, who were not compliant with the study protocol or not compliant with the study treatments according to investigator's judgement.
  • Major surgery in the previous 3 months and during the trial which could affect patient's compliance in the study procedures (e.g. spirometry).
  • Participation in another clinical trial with an investigational drug in the 2 months preceding visit 1.
  • Patients requiring chronic mechanical ventilation for COPD

Who cannot join

None listed.

Trial locations and contacts

68 sites in 10 countries.

68 sites in 10 countries

Poland13 sites

  • NZOZ "Non Nocere"

    Gdansk

  • Niepubliczny Zakład Opieki Zdrowotnej "PROFILAKTYKA"

    Koszalin

  • Szpital Specjalistyczny im Jana Pawła II

    Krakow

  • Szpital Uniwersytecki w Krakowie

    Krakow

  • Prywatny Gabinet Specjalistyczny

    Lodz

  • Samodzielny Publiczny Szpital Kliniczny

    Szczecin

  • Chorób Płuc

    Warsaw

  • Gabinet Lekarski SERIA IWONA GRZELEWSKA-RZYMOWSKA

    Warsaw

  • Instytut Gruźlicy i Chorób Płuc. Zakład Diagnostyki i Leczenia Niewydolności Oddychania

    Warsaw

  • Zakład Fizjopatologii Oddychania, Instytut Gruźlicy i Chorób Płuc

    Warsaw

  • DOBROSTAN - Gabinety Lekarskie

    Wroclaw

  • NZOZ Lekarze Specjaliści J.Małolepszy i Partnerzy

    Wroclaw

  • Wojewódzki Szpital Specjalistyczny im. M. Curie-Skłodowskiej)

    Zgierz

Other trials in Poland

Turkey (Türkiye)10 sites

  • Çukurova Üniversitesi

    Adana

  • Akdeniz Üniversitesi

    Antalya

  • Bilim Üniversitesi

    Antalya

  • Ege Universitesi

    Bornova

  • Uludag Üniversitesi

    Bursa

  • Gaziantep Üniversitesi

    Gaziantep

  • Fatih Üniversitesi

    Istanbul

  • Marmara Üniversitesi

    Istanbul

  • Dokuz Eylül Üniversitesi

    Izmir

  • Erciyes Üniversitesi

    Kayseri

Other trials in Turkey (Türkiye)

Germany9 sites

  • Praxis Dr. Jorg Kampschulte

    Berlin

  • Praxis Dr. Jörg Winkler

    Leipzig

  • KLB Healthresearch

    Lübeck

  • KLD Helthreseach

    Lübeck

  • SMO.MD GmbH Zentrum für Klinische Studien

    Magdeburg

  • Pneumologische Gemeinschaftspraxis Saarbrücken

    Saarbrücken

  • Fachinternistische Gemeinschafts

    Wedel

  • Pneumologische Praxis Dr Redlich

    Wiesloch

  • Gemeinschaftspraxis für Pneumologie

    Wuppertal

Other trials in Germany

Hungary9 sites

  • Dr. Kenessey Albert Kórház - Rendelőintézet

    Balassagyarmat

  • Békés Megyei Képviselő-testület Pándy Kálmán Kórház

    Békés

  • Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház

    Budapest

  • Centrum-Tüdőgyógyászati Klinika

    Debrecen

  • Bács-Kiskun Megeyi Önkormanyzat...

    Kecskemét

  • Karolina Kórház és Rendelőintézet Tüdőgyógyászat

    Mosonmagyaróvár

  • Békés Megyei Képviselő-testület Pándy Kálmán Kórház

    Nyíregyháza

  • Jósa András Hospital

    Nyíregyháza

  • Chiesi Clinical Centre Szigetszentmiklös

    Szigetszentmiklös

Other trials in Hungary

Slovakia8 sites

  • Neštátna ambulancia pneumológie a ftizeológie, Nemocničná

    Humenné

  • Diunea, sro. Ambulancia PaF

    Nové Zámky

  • ALERGOIMUNO s.r.o

    Ostrov

  • Pľúcna ambulancia, Poliklinika ADUS

    Poprad

  • PULMO, s.r.o

    Prešov

  • PNEUMO-MED, s.r.o

    Prievidza

  • Pľúcna ambulancia, Hrebenár s.r.o

    Spišská Nová Ves

  • PNEUMO-CENTRUM, s.r.o, Poliklinika

    Trnava

Other trials in Slovakia

Italy7 sites

  • Ospedale Sant'Orsola-Malpighi

    Bologna

  • A.O. Policlinico

    Catania

  • A.O. S. Gerardo

    Monza

  • Azienda Ospedaliera Monaldi

    Naples

  • Università di Pisa

    Pisa

  • IRCCS San Raffaele La Pisana

    Roma

  • Policlinico Umberto I - VIII Padiglione

    Rome, 00161

Other trials in Italy

Denmark5 sites

  • Aarhus University Hospital

    Aarhus

  • Bispebjerg Hospital

    Copenhagen

  • Dept. of Cardiology and Respiratory Medicine

    Copenhagen

  • Gentofte Hospital

    Gentofte Municipality

  • Odense University Hospital

    Odense

Other trials in Denmark

Spain3 sites

  • Hospital del Mar

    Barcelona

  • Hospital Parc Taulí

    Sabadell

  • Hospital General Vic

    Vic

Other trials in Spain

United Kingdom3 sites

  • Belfast City Hospital

    Belfast

  • Kings College Hospital

    London

  • Freeman Hospital

    Newcastle

Other trials in United Kingdom

France1 site

  • Centre Hospitalier

    Toulon

Other trials in France

About this study

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

The primary objective of the study was to demonstrate the superiority of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), in terms of pulmonary function (AUC0-30min standardized by time of change from pre-dose in FEV1) after drug inhalation in the morning of day 1, and the equivalence between Foster® 100/6 (two puffs b.i.d.) and Seretide® 500/50 (one inhalation b.i.d.) in terms of Transition Dyspnoea Index (TDI) score at day 84 in patients with COPD.

The secondary objectives of the study were:

  • To evaluate the efficacy of the test treatments in terms of additional spirometric parameters and of clinical outcome measures;
  • To assess the safety and tolerability;
  • To perform an exploratory analysis evaluating the consumption of resources deriving from COPD management in the perspective of the Healthcare System.
Read the detailed description

This was a phase IIIb, multicentre, multinational, randomized, double-blind, double-dummy, 2-arm parallel group design preceded by a 2-week run-in period in patients with COPD. The study compared the efficacy and safety of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), over a 12-week treatment period.

The study plan included:

  • A pre-screening visit (V0, at week -3 days before the randomization visit) during which clinical instructions to determine patients' adaptability to the study procedures were given. This could be done only after the participants agreed to participate and signed the Informed Consent form;
  • A screening visit (V1, week -2) in which patients with COPD were selected;
  • A run-in period, lasting from a minimum of 12 to a maximum of 16 days, where patients received a standardised treatment with inhaled aerosol ipratropium bromide (Atrovent® Inhaler CFC-free 20 μg), 1 inhalation four times daily (daily dose of 80 μg) and had any nonpermitted medication withdrawn prior to entry into test treatment period;
  • A randomisation visit (V2, week 0) during which patients were randomly allocated to one of the two treatment arms, and subsequent visits taking place at clinics after 4 (V3), after 8 (V4) and after 12 weeks (V5) of treatment. The end of the trial was defined as the last visit of the last subject on the trial. After 7-10 days of last study medication intake, a follow-up phone contact to document and treat adverse events that might possibly occur was performed.

The total study duration per participant was 16 weeks, including the 2-week run-in period, 12-week treatment phase, and 7-10 days of follow-up.

Salbutamol was used as a rescue medication.

Being tested
Beclomethasone Dipropionate - Formoterol, Fluticasone - Salmeterol
Keywords
Foster, Seretide, COPD
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Beclomethasone Dipropionate - FormoterolDrug

    Also called Foster

    Administered via a pressurized metered-dose inhaler

  • Fluticasone - SalmeterolDrug

    Also called Seretide Accuhaler®

    Administered via a pressurized metered-dose inhaler

Study groups in NCT01245569
Study groupRoleWhat they receive
Foster®ExperimentalParticipants received 2 puffs of Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) administered via a pMDI twice daily (BID), resulting in a total daily dose of beclomethasone dipropionate 400 μg plus formoterol 24 μg, for a duration of 12 weeks. To ensure blinding, participants received one inhalation of placebo matching Seretide® Accuhaler® via a inhaler BID, for a duration of 12 weeks.
Receives: Drug: Beclomethasone Dipropionate - Formoterol
Seretide® Accuhaler®Active comparatorParticipants received one inhalation of Seretide® Accuhaler® (fluticasone 500 μg plus salmeterol 50 μg/actuation) administered via inhaler, BID resulting in a total daily dose of fluticasone 1000 μg plus salmeterol 100 μg, for a duration of 12 weeks. To ensure blinding, participants receieved two puffs of placebo matching Foster® via pMDI, BID for a duration of 12 weeks.
Receives: Drug: Fluticasone - Salmeterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessment were implemented at pre-dose, and 5, 15 and 30 minutes post inhalation

    Measured: on Day 1 (V2)

  2. Transition Dyspnoea Index (TDI) Score at Day 84

    TDI has three domains as follows:

    1. Functional impairment, which determines the impact of breathlessness on the ability to carry out activities;
    2. Magnitude of task, which determines the type of task that causes breathlessness;
    3. Magnitude of effort, which establishes the level of effort that results in breathlessness

    The TDI score ranges from -3 (major deterioration) to +3 (major improvement) for each domain. The sum of all domains yields the TDI focal score of -9 (major deterioration) to +9 (major improvement).

    Adjusted means were reported.

    Measured: Day 84 (V5)

Secondary outcomes (18)

  1. AUC 0-30min Standardized by Time of Change From Pre-dose in FEV1 in the Morning of Day 84

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented pre-dose, 5, 15 and 30 minutes post inhalation.

    Measured: on Day 84 (V5)

  2. AUC 0-30min Standardized by Time of Change From Baseline in FEV1 After Drug Inhalation in the Morning of Day 84

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported. Assessments were implemented at baseline and 5,15 and 30 minutes post inhalation.

    Measured: on Day 84 (V5)

  3. Change From Baseline (CFB) in Pre-dose Morning FEV1

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.

    Measured: Weeks 4, 8 and 12

  4. Change From Baseline in Pre-dose Morning Forced Vital Capacity (FVC)

    FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.

    Measured: Weeks 4, 8 and 12

  5. Change From Pre-dose in Morning FEV1 at 5, 15 and 30 Min After Drug Intake

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.

    Measured: 5, 15, 30 Min post inhalation at Weeks 0 (V2) and 12 (Day 84, V5)

  6. Change From Baseline in Morning FEV1 at 5, 15 and 30 Min After Drug Intake

    FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured using spirometry, conducted at baseline and all clinical visits. An increase in FEV1 reflects improved airway patency, while a decrease suggests worsening obstruction. Higher FEV1 values indicate better lung function. Adjusted means were reported.

    Measured: at 5, 15 and 30 mins post inhalation at Week 12 (Day 84, V5)

  7. Change From Pre-dose in Morning FVC at 5, 15 and 30 Min After Drug Intake

    FVC is is a measure of lung function and is defined as the amount of air that can be forcefully exhaled from lungs after taking the deepest breath possible, FVC was measured using spirometry at baseline and all clinical visits. Higher values indicate improved lung capacity and reduced airway obstruction. Adjusted means were reported.

    Measured: at 5, 15 and 30 min post inhalation Week 0 (V2) & Week 12 Day 84, (V5)

  8. Change From Baseline to Each Two-Week Period in COPD Symptom Scores

    COPD symptom scores consists of following 6 items recorded by the participants in diary.

    • the ability to perform the usual daily activities;
    • breathlessness over the previous 24h;
    • waking at night due to respiratory symptoms;
    • breathlessness on rising;
    • cough over the previous 24h;
    • sputum production over the previous 24h.

    Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst). Baseline COPD symptom score has been calculated as the mean of the COPD symptom scores recorded in the run-in period. Each item or total scores were averaged over each 2 week period. Average COPD symptom score in each two-week period has been calculated as the mean of the item or total score recorded in each two-week period. Adjusted means were reported.

    Measured: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

  9. Change From Baseline to Each Two-Week Period in Percentage of COPD Symptom-Free Days

    COPD symptom scores consists of following 6 items recorded by the participants in diary.

    • ability to perform the usual daily activities;
    • breathlessness over the previous 24h;
    • waking at night due to respiratory symptoms;
    • breathlessness on rising;
    • cough over the previous 24h;
    • sputum production over the previous 24h.

    Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst).

    A COPD symptom-free day is a day with total COPD symptom scores = 0. Baseline % of COPD symptom-free days is calculated as the % ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)*100.

    Reported values (in form of adjusted means) reflect a percentage (%).

    % of COPD symptom-free days in each two-week period is calculated as % (ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)*100.

    Measured: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

  10. Change From Baseline to Entire Treatment Period in Percentage of COPD Symptom-Free Days

    COPD symptom scores consists of following 6 items recorded by the participants in diary.

    • ability to perform the usual daily activities;
    • breathlessness over the previous 24h;
    • waking at night due to respiratory symptoms;
    • breathlessness on rising;
    • cough over the previous 24h;
    • sputum production over the previous 24h.

    Each symptom score is recorded on a scale from 0 (no symptoms) to 3 (worst), the total score ranges from 0 (no symptoms) to 18 (worst).

    A COPD symptom-free day is a day with total COPD symptom scores = 0. Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of COPD symptom-free days is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the run-in period)*100.

    % of COPD symptom-free days in each two-week period is calculated as (% ratio between the number of COPD symptom-free days and the number of days with data recorded in the two-week period)*100.

    Measured: Baseline, Weeks 1 through 12

  11. Change From Baseline to Each Two-Week Period in Average Use of Rescue Salbutamol Consumption

    Number of rescue salbutamol puffs per day were recorded in the diary. Baseline use of rescue medication has been calculated as the mean number of puffs per day in the run-in period. Average use of rescue medication in each two-week period has been calculated as the mean number of puffs per day in each two week period. Adjusted means were reported.

    Measured: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

  12. Change From Baseline to Each Two-Week Period in Percentage of Rescue Salbutamol-Free Days

    A rescue medication-free day is a day with number of puffs of rescue medication = 0.

    Reported values (in form of adjusted means) reflect a percentage (%). Baseline percentage (%) of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)*100.

    % of rescue medication-free days in each two-week period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the two-week period)*100.

    Measured: Weeks 1-2, 3-4, 5-6, 7-8, 9-10, 11-12

  13. Change From Baseline to Entire Treatment Period in Percentage of Rescue Salbutamol-Free Days

    A rescue medication-free day is a day with number of puffs of rescue medication = 0.

    Reported values (in form of adjusted means) reflect a percentage (%). Baseline % of rescue medication-free days is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the run-in period)*100.

    % of rescue medication-free days in the entire treatment period is calculated as (% ratio between the number of rescue medication-free days and the number of days with data recorded in the entire treatment period)*100.

    Measured: at week 12 (V5)

  14. Change From Baseline in the St George's Respiratory Questionnaire (SGRQ) Component and Total Scores

    SGRQ is a 76-item questionnaire developed to measure health in chronic airflow limitation and designed to be self-completed by the participant. It consists of 76-items across three domains:

    • Symptoms, which evaluates the frequency and severity of respiratory issues like coughing, sputum production, and breathlessness;
    • Activity, which measures limitations in physical activities due to breathlessness;
    • Impacts, which examines psychological and social effects, including feelings of stigma, loss of control, and daily life disruption.

    Each domain score ranges from 0 to 100 with higher scores indicating the worst health status. Total score was obtained by combining the weighted scores from each domain and ranging from 0 (better health) to 100 (Worst health).

    Measured: at Week 12 (V5)

  15. Change From Baseline in Pre-dose and in Post-dose Distance Walked (6 Minute Walking Test - 6MWT)

    The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start. The longer distance covered, the better the outcome.

    Measured: Week 12 (V5), pre-dose and post-dose

  16. Change From Pre-dose in Post-dose Distance Walked (6MWT)

    The 6MWT was carried out following standardized procedures, according to ATS guidelines. The test was performed indoors, along a long, flat, straight, 30m-long corridor, and one well-trained researcher supervised the test. Prior to start walking, patients were explained that the aim of the test was to walk from end to end along the corridor and to cover as much distance as possible in the period of 6 minutes. The patients sit at rest for at least 10 minutes before the test start.

    Measured: on Week 0 (Day 1, V2) and Week 12 (V5, Day 84)

  17. Number of Participants With COPD Exacerbations From Week 0 Through Week 12

    A COPD exacerbation is defined as "a sustained worsening of the participants condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and requires unscheduled medical intervention [leading to prescriptions of systemic corticosteroids (at least 3 days)] and/or antibiotics (at least 5 days), or need for a visit to an emergency department or hospitalization) in a participant with underlying COPD".

    Measured: Week 12

  18. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    AE=An untoward medical occurrence after exposure to a medicine, which is not necessarily caused by that medicine.

    Serious AE= An adverse event that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.

    ADR=A response to a medicinal product which is harmful and unintended. Response in this context means that a causal relationship between the medicinal product and an adverse event is at least a reasonable possibility Serious ADR=An adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect.

    Severe AE= "Severe" refers to the intensity of an AE; the event itself may be of relatively minor medical significance but intense.

    Measured: From first dose of study drug until end of the treatment (up to 84 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2010 (estimated)
  2. Study start12 Apr 2011
  3. Primary completion13 Mar 2012
  4. Study completion13 Mar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
419 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01245569
Sponsor's protocol ID
CCD-0910-PR-0021
Other IDs
2009-014410-10, 2009
Acronym
FUTURE
Status last verified
Jun 2026
First submitted
19 Nov 2010
Last updated
10 Aug 2026
Data monitoring committee
No

Publications

  • 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.

    PubMed 24621109

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Beclomethasone Dipropionate - Formoterol and Fluticasone - Salmeterol in people with Chronic Obstructive Pulmonary Disease, run by Chiesi Farmaceutici S.p.A. at 68 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in Poland, Turkey (Türkiye), Germany, Hungary, Slovakia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Area Under the Curve (AUC) 0-30min Standardized by Time of Change From Pre-dose in Forced Expiratory Volume in One Second (FEV1) in the Morning of Day 1 (time frame: on Day 1 (V2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01245569, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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FUTURE Clinical Trial NCT01245569 | AzTrials