A Study in Patients With Chronic Obstructive Pulmonary Disease

NCT01245569 | Completed Phase 3 Results

• 2 other identifiers: CCD-0910-PR-00212009-014410-10
• Study Type: interventional
• Target: 419
• Locations: 10 countries
• Sites: 68

Brief 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 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Foster; Seretide; COPD

Outcome Measures

Primary Outcomes (2)

• 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

  on Day 1 (V2)

• 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.

  Day 84 (V5)

Secondary Outcomes (18)

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

  on Day 84 (V5)

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

  on Day 84 (V5)

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

  Weeks 4, 8 and 12

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

  Weeks 4, 8 and 12

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

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

Study Arms (2)

Foster®

EXPERIMENTAL

Participants 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.

Drug: Beclomethasone Dipropionate - Formoterol

Seretide® Accuhaler®

ACTIVE COMPARATOR

Participants 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.

Drug: Fluticasone - Salmeterol

Interventions

Beclomethasone Dipropionate - Formoterol DRUG

Administered via a pressurized metered-dose inhaler

Also known as: Foster

Foster®

Fluticasone - Salmeterol DRUG

Administered via a pressurized metered-dose inhaler

Also known as: Seretide Accuhaler®

Seretide® Accuhaler®

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (68)

Aarhus University Hospital

Aarhus, Denmark

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Dept. of Cardiology and Respiratory Medicine

Copenhagen, Denmark

Location

Gentofte Hospital

Gentofte Municipality, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Centre Hospitalier

Toulon, France

Location

Praxis Dr. Jorg Kampschulte

Berlin, Germany

Location

Praxis Dr. Jörg Winkler

Leipzig, Germany

Location

KLB Healthresearch

Lübeck, Germany

Location

KLD Helthreseach

Lübeck, Germany

Location

SMO.MD GmbH Zentrum für Klinische Studien

Magdeburg, Germany

Location

Pneumologische Gemeinschaftspraxis Saarbrücken

Saarbrücken, Germany

Location

Fachinternistische Gemeinschafts

Wedel, Germany

Location

Pneumologische Praxis Dr Redlich

Wiesloch, Germany

Location

Gemeinschaftspraxis für Pneumologie

Wuppertal, Germany

Location

Dr. Kenessey Albert Kórház - Rendelőintézet

Balassagyarmat, Hungary

Location

Békés Megyei Képviselő-testület Pándy Kálmán Kórház

Békés, Hungary

Location

Szabolcs-Szatmár-Bereg Megyei Önkormányzat Jósa András Oktató Kórház

Budapest, Hungary

Location

Centrum-Tüdőgyógyászati Klinika

Debrecen, Hungary

Location

Bács-Kiskun Megeyi Önkormanyzat...

Kecskemét, Hungary

Location

Karolina Kórház és Rendelőintézet Tüdőgyógyászat

Mosonmagyaróvár, Hungary

Location

Békés Megyei Képviselő-testület Pándy Kálmán Kórház

Nyíregyháza, Hungary

Location

Jósa András Hospital

Nyíregyháza, Hungary

Location

Chiesi Clinical Centre Szigetszentmiklös

Szigetszentmiklös, Hungary

Location

Ospedale Sant'Orsola-Malpighi

Bologna, Italy

Location

A.O. Policlinico

Catania, Italy

Location

A.O. S. Gerardo

Monza, Italy

Location

Azienda Ospedaliera Monaldi

Naples, Italy

Location

Università di Pisa

Pisa, Italy

Location

IRCCS San Raffaele La Pisana

Roma, Italy

Location

Policlinico Umberto I - VIII Padiglione

Rome, 00161, Italy

Location

NZOZ "Non Nocere"

Gdansk, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej "PROFILAKTYKA"

Koszalin, Poland

Location

Szpital Specjalistyczny im Jana Pawła II

Krakow, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, Poland

Location

Prywatny Gabinet Specjalistyczny

Lodz, Poland

Location

Samodzielny Publiczny Szpital Kliniczny

Szczecin, Poland

Location

Chorób Płuc

Warsaw, Poland

Location

Gabinet Lekarski SERIA IWONA GRZELEWSKA-RZYMOWSKA

Warsaw, Poland

Location

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

Warsaw, Poland

Location

Zakład Fizjopatologii Oddychania, Instytut Gruźlicy i Chorób Płuc

Warsaw, Poland

Location

DOBROSTAN - Gabinety Lekarskie

Wroclaw, Poland

Location

NZOZ Lekarze Specjaliści J.Małolepszy i Partnerzy

Wroclaw, Poland

Location

Wojewódzki Szpital Specjalistyczny im. M. Curie-Skłodowskiej)

Zgierz, Poland

Location

Neštátna ambulancia pneumológie a ftizeológie, Nemocničná

Humenné, Slovakia

Location

Diunea, sro. Ambulancia PaF

Nové Zámky, Slovakia

Location

ALERGOIMUNO s.r.o

Ostrov, Slovakia

Location

Pľúcna ambulancia, Poliklinika ADUS

Poprad, Slovakia

Location

PULMO, s.r.o

Prešov, Slovakia

Location

PNEUMO-MED, s.r.o

Prievidza, Slovakia

Location

Pľúcna ambulancia, Hrebenár s.r.o

Spišská Nová Ves, Slovakia

Location

PNEUMO-CENTRUM, s.r.o, Poliklinika

Trnava, Slovakia

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Parc Taulí

Sabadell, Spain

Location

Hospital General Vic

Vic, Spain

Location

Çukurova Üniversitesi

Adana, Turkey (Türkiye)

Location

Akdeniz Üniversitesi

Antalya, Turkey (Türkiye)

Location

Bilim Üniversitesi

Antalya, Turkey (Türkiye)

Location

Ege Universitesi

Bornova, Turkey (Türkiye)

Location

Uludag Üniversitesi

Bursa, Turkey (Türkiye)

Location

Gaziantep Üniversitesi

Gaziantep, Turkey (Türkiye)

Location

Fatih Üniversitesi

Istanbul, Turkey (Türkiye)

Location

Marmara Üniversitesi

Istanbul, Turkey (Türkiye)

Location

Dokuz Eylül Üniversitesi

Izmir, Turkey (Türkiye)

Location

Erciyes Üniversitesi

Kayseri, Turkey (Türkiye)

Location

Belfast City Hospital

Belfast, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Related 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 fluticasone/salmeterol combination therapy in COPD. BMC Pulm Med. 2014 Mar 12;14:43. doi: 10.1186/1471-2466-14-43.

  PMID: 24621109 RESULT

Related Links

• Study Record on EU Clinical Trials Register including results

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Foster Home Care; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Clinical Trial INFO
• Organization: Chiesi Farmaceutici S.p.A.

clinicaltrials_info@chiesi.com

+39 0521 2791

Study Officials

• Dave Singh, MD

  The Medicine Evaluation Unit - Manchester, UK

  PRINCIPAL INVESTIGATOR

• Jorgen Vestbo, MD

  Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: April 12, 2011
• Primary Completion: March 13, 2012
• Study Completion: March 13, 2012
• Last Updated: August 10, 2026
• Results First Posted: August 10, 2026

Record last verified: 2026-06

Locations

IT (7); FR (1); DE (9); DK (5); PL (13); HU (9); SL (8); ES (3); TU (10); GB (3)