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Which inhaler breathes better? a Head-to-Head COPD showdown

NCT ID NCT01245569

Disease control Sponsor: Chiesi Farmaceutici S.p.A. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial compares two widely used combination inhalers—Foster (beclomethasone plus formoterol) and Seretide (fluticasone plus salmeterol)—in people with chronic obstructive pulmonary disease (COPD). The goal is to see if Foster works better at improving lung function right after use and whether it is equally effective at reducing breathlessness over 12 weeks. About 419 adults aged 40 and older with a smoking history are taking part. The study measures lung function and symptom changes to help determine which inhaler may offer better daily control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Two combination inhalers: beclomethasone dipropionate plus formoterol (Foster) versus fluticasone plus salmeterol (Seretide)
What this could lead to
If Foster proves superior or equivalent, it could offer a more effective or convenient treatment option for managing COPD symptoms and improving daily breathing.
What could go wrong
This is a 12-week trial, so long-term benefits or risks are not addressed. Results may not apply to all COPD patients, and individual responses to inhalers can vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

419 people

The number who actually took part.

Started

Apr 2011

Finished

Mar 2012

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Diagnosis of asthma or respiratory disorders (other than COPD) which could interfere with data interpretation according to the investigator's opinion. 2. 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: 1. Surgical sterilization (e.g., bilateral tubal ligation, hysterectomy); 2. Hormonal contraception (implantable, patch, oral, injectable); 3. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/cream/suppository. 4. 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. 3. 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. 4. Patient with narrow-angle glaucoma. 5. 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. 6. Patients with COPD exacerbation (see previous at inclusion criteria no. 3) in the 2 months prior to screening and during the study period. 7. Patients requiring long term (\> 12 hours daily) oxygen therapy for chronic hypoxemia. 8. Patients treated with depot corticosteroids in the 2 months preceding the visit 1 and during the run-in period. 9. Patients with known allergy, sensitivity or intolerance to sympathomimetic drugs or inhaled corticosteroids or to any of the excipients contained in the study drugs. 10. 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. 11. Major surgery in the previous 3 months and during the trial which could affect patient's compliance in the study procedures (e.g. spirometry). 12. Participation in another clinical trial with an investigational drug in the 2 months preceding visit 1. 13. Patients requiring chronic mechanical ventilation for COPD

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease

Contacts and locations

Locations

  • A.O. Policlinico

    Catania, Italy

  • A.O. S. Gerardo

    Monza, Italy

  • ALERGOIMUNO s.r.o

    Ostrov, Slovakia

  • Aarhus University Hospital

    Aarhus, Denmark

  • Akdeniz Üniversitesi

    Antalya, Turkey (Türkiye)

  • Azienda Ospedaliera Monaldi

    Naples, Italy

  • Belfast City Hospital

    Belfast, United Kingdom

  • Bilim Üniversitesi

    Antalya, Turkey (Türkiye)

  • Bispebjerg Hospital

    Copenhagen, Denmark

  • Bács-Kiskun Megeyi Önkormanyzat...

    Kecskemét, Hungary

  • Békés Megyei Képviselő-testület Pándy Kálmán Kórház

    Békés, Hungary

  • Békés Megyei Képviselő-testület Pándy Kálmán Kórház

    Nyíregyháza, Hungary

  • Centre Hospitalier

    Toulon, France

  • Centrum-Tüdőgyógyászati Klinika

    Debrecen, Hungary

  • Chiesi Clinical Centre Szigetszentmiklös

    Szigetszentmiklös, Hungary

  • Chorób Płuc

    Warsaw, Poland

  • DOBROSTAN - Gabinety Lekarskie

    Wroclaw, Poland

  • Dept. of Cardiology and Respiratory Medicine

    Copenhagen, Denmark

  • Diunea, sro. Ambulancia PaF

    Nové Zámky, Slovakia

  • Dokuz Eylül Üniversitesi

    Izmir, Turkey (Türkiye)

  • Dr. Kenessey Albert Kórház - Rendelőintézet

    Balassagyarmat, Hungary

  • Ege Universitesi

    Bornova, Turkey (Türkiye)

  • Erciyes Üniversitesi

    Kayseri, Turkey (Türkiye)

  • Fachinternistische Gemeinschafts

    Wedel, Germany

  • Fatih Üniversitesi

    Istanbul, Turkey (Türkiye)

  • Freeman Hospital

    Newcastle, United Kingdom

  • Gabinet Lekarski SERIA IWONA GRZELEWSKA-RZYMOWSKA

    Warsaw, Poland

  • Gaziantep Üniversitesi

    Gaziantep, Turkey (Türkiye)

  • Gemeinschaftspraxis für Pneumologie

    Wuppertal, Germany

  • Gentofte Hospital

    Gentofte Municipality, Denmark

  • Hospital General Vic

    Vic, Spain

  • Hospital Parc Taulí

    Sabadell, Spain

  • Hospital del Mar

    Barcelona, Spain

  • IRCCS San Raffaele La Pisana

    Roma, Italy

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

    Warsaw, Poland

  • Jósa András Hospital

    Nyíregyháza, Hungary

  • KLB Healthresearch

    Lübeck, Germany

  • KLD Helthreseach

    Lübeck, Germany

  • Karolina Kórház és Rendelőintézet Tüdőgyógyászat

    Mosonmagyaróvár, Hungary

  • Kings College Hospital

    London, United Kingdom

  • Marmara Üniversitesi

    Istanbul, Turkey (Türkiye)

  • NZOZ "Non Nocere"

    Gdansk, Poland

  • NZOZ Lekarze Specjaliści J.Małolepszy i Partnerzy

    Wroclaw, Poland

  • Neštátna ambulancia pneumológie a ftizeológie, Nemocničná

    Humenné, Slovakia

  • Niepubliczny Zakład Opieki Zdrowotnej "PROFILAKTYKA"

    Koszalin, Poland

  • Odense University Hospital

    Odense, Denmark

  • Ospedale Sant'Orsola-Malpighi

    Bologna, Italy

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

    Trnava, Slovakia

  • PNEUMO-MED, s.r.o

    Prievidza, Slovakia

  • PULMO, s.r.o

    Prešov, Slovakia

  • Pneumologische Gemeinschaftspraxis Saarbrücken

    Saarbrücken, Germany

  • Pneumologische Praxis Dr Redlich

    Wiesloch, Germany

  • Policlinico Umberto I - VIII Padiglione

    Rome, 00161, Italy

  • Praxis Dr. Jorg Kampschulte

    Berlin, Germany

  • Praxis Dr. Jörg Winkler

    Leipzig, Germany

  • Prywatny Gabinet Specjalistyczny

    Lodz, Poland

  • Pľúcna ambulancia, Hrebenár s.r.o

    Spišská Nová Ves, Slovakia

  • Pľúcna ambulancia, Poliklinika ADUS

    Poprad, Slovakia

  • SMO.MD GmbH Zentrum für Klinische Studien

    Magdeburg, Germany

  • Samodzielny Publiczny Szpital Kliniczny

    Szczecin, Poland

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

    Budapest, Hungary

  • Szpital Specjalistyczny im Jana Pawła II

    Krakow, Poland

  • Szpital Uniwersytecki w Krakowie

    Krakow, Poland

  • Uludag Üniversitesi

    Bursa, Turkey (Türkiye)

  • Università di Pisa

    Pisa, Italy

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

    Zgierz, Poland

  • Zakład Fizjopatologii Oddychania, Instytut Gruźlicy i Chorób Płuc

    Warsaw, Poland

  • Çukurova Üniversitesi

    Adana, Turkey (Türkiye)

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