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Can one inhaler do it all for asthma? new study tests simpler approach

NCT ID NCT00861926

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using Foster (a combination inhaler) for both daily maintenance and as-needed relief works better than using Foster daily plus a separate salbutamol rescue inhaler. Over 1,700 adults with not fully controlled asthma took part for 48 weeks. The main goal was to see which approach better prevented severe asthma attacks.

What this could mean

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

Active substance
Beclomethasone dipropionate + Formoterol (Foster) and Salbutamol
What this could lead to
If successful, this could show that using Foster for both daily control and symptom relief is as good as or better than the standard approach of separate rescue inhalers.
What could go wrong
This is a completed Phase 3 trial, so results are already known. The main risk is that the MART approach may not reduce severe asthma attacks more than standard care.

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

1,714 people

The number who actually took part.

Started

Mar 2009

Finished

Dec 2010

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

18 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. Written signed and dated informed consent obtained from patient; 2. Male or female patients aged ≥ 18 years; 3. Clinical diagnosis of asthma for ≥ 6 months; 4. A positive reversibility test, defined as an increase of at least 12% and at least 200 mL from pre-dose in FEV1 30 minutes following 4 puffs (4 × 100 μg) of inhaled salbutamol pMDI. If this could not be achieved, a documented reversibility test to salbutamol within the last 6 months was acceptable for eligibility; 5. Patients who experienced at least one severe exacerbation in the 12 months before entry (but not in the last month), defined as deterioration in asthma resulting in hospitalization or emergency room treatment due to asthma worsening, or the need for systemic steroids for at least 3 days because of asthma; 6. Using inhaled corticosteroids (ICS) in monotherapy or using ICS in a fixed or free combination with long acting β2 agonists (LABA) at a constant dose (changes in doses for less than seven days were accepted) for two months before V1. * If patients were under ICS only, the daily dose had to be ≥ non-extrafine 1000 μg BDP or equivalent. * If patients were under ICS + LABA, the ICS daily dose had to be ≥ non-extrafine 500 μg BDP or equivalent. LABA were to be stopped at least 24 hours before V1. 7. Not fully controlled asthmatics (which means partly controlled or/and uncontrolled patients according to GINA guidelines 2007) (apart from asthma exacerbation criteria) in the last month before V1. Asthma control was assessed in terms of: * Daytime symptoms (more than twice a week); * Limitation of activities (any); * Nocturnal symptoms/awakening (any); * Need for rescue (more than twice a week); * Forced expiratory volume in the first second (FEV1) \< 80% predicted (or personal best, if known) on any day. Partly controlled patients were those with at least one of the above mentioned symptoms/signs in any week of the last month before V1. Uncontrolled patients were those with 3 or more features of partly controlled asthma present in any week of the last month before V1. 8. FEV1 ≥ 60% of predicted for the patient normal value; 9. Non smokers or ex-smokers (defined as those who have stopped smoking for more than one year and with a smoking history of less than 10 pack/years); Pack/year: number of cigarettes smoked per day multiplied by the number of years of smoking/20. 10. A co-operative attitude and ability to be trained to correctly use the pMDI; 11. Subjects who were willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Not fully controlled asthma (defined according to criterion No. 7) in the last week of the run-in was to be confirmed at Visit 2. Exclusion Criteria: 1. Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (\> 5 mIU/mL). Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precluded intercourse with a male partner and women whose partners had been sterilized by vasectomy or other means, unless they met the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels \> 40 mIU/mL 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); 3. Double-barrier methods (any double combination of: IUD, male or female condom, diaphragm, sponge, cervical cap). Acceptable methods of contraception could include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensured compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal were not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation; 2. Body Mass Index (BMI) \> 34 kg/m2; 3. Patients with lower respiratory tract infections affecting the patient's asthma within 30 days of the screening visit; 4. Use of systemic steroids in the last month; 5. Patients with other lung diseases such as (but not limited to) COPD, cystic fibrosis, interstitial lung diseases or any other clinically or functionally significant lung disorder; 6. Patients who had an uncontrolled respiratory, haematological, immunologic, renal, neurologic, hepatic, endocrinal or other disease, or any condition that could, in the judgment of the investigator, represent for the patients an undue risk or that could compromise the results or interpretation of the study; 7. History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias; 8. Cancer or any other chronic disease with poor prognosis (less than 2 years) and /or affecting patient status; 9. Clinically relevant laboratory abnormalities such as (but not limited to) hypokaliemia (\<3.5 mEq/L), that could compromise patient's safety or compliance, interfere with evaluation, or preclude completion of the study, in the judgment of the investigator. Patients with uncontrolled diabetes, including patients with a history of serum glucose levels consistently out of the normal range (\> 140 mg/dl) or HbA1c \> 8.0%, were to be excluded from the study; 10. Patients who had an abnormal QTcF interval value in the screening visit ECG test (i.e., \> 450 msec in males or \> 470 msec in females); 11. Intolerance or contra-indication to treatment with β2-agonists and/or ICS or allergy to any component of the study treatments; 12. Patients treated with slow-release corticosteroids in the 3 months prior to screening visit; 13. Patients unlikely to comply with the study protocol or unable to understand the nature and scope of the study or the possible benefits or unwanted effects of the study treatments; 14. Patients being treated with anti-IgE antibodies; 15. Patients treated with LABA or ICS/LABA fixed combination in the 24 hours before visit 1; 16. Patients having received an investigational drug within 2 months before the screening visit; 17. Inability to comply to study procedures or to study treatment intake; 18. Inability to carry out a valid spirometry; 19. Severe asthma exacerbation in the last month before screening visit; 20. Severe asthma exacerbation during the run-in period.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

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

Asthma

Contacts and locations

Locations

  • Chiesi Site No 0101

    Varna, Bulgaria

  • Chiesi Site No 1001

    Belgrade, Serbia

  • Chiesi Site No 1002

    Kamenitz, Serbia

  • Chiesi Site No 1003

    Belgrade, Serbia

  • Chiesi Site No 1004

    Kragujevac, Serbia

  • Chiesi Site No 1005

    Niš, Serbia

  • Chiesi Site No 102

    Rousse, Bulgaria

  • Chiesi Site No 103

    Burgas, Bulgaria

  • Chiesi Site No 104

    Sofia, Bulgaria

  • Chiesi Site No 105

    Plovdiv, Bulgaria

  • Chiesi Site No 106

    Stara Zagora, Bulgaria

  • Chiesi Site No 107

    Pleven, Bulgaria

  • Chiesi Site No 108

    Sofia, Bulgaria

  • Chiesi Site No 109

    Sofia, Bulgaria

  • Chiesi Site No 110

    Sofia, Bulgaria

  • Chiesi Site No 1101

    Badalona, Spain

  • Chiesi Site No 1102

    Lleida, Spain

  • Chiesi Site No 1105

    Terrassa, Spain

  • Chiesi Site No 1106

    Zaragoza, Spain

  • Chiesi Site No 111

    Plovdiv, Bulgaria

  • Chiesi Site No 112

    Veliko Tarnovo, Bulgaria

  • Chiesi Site No 113

    Sofia, Bulgaria

  • Chiesi Site No 115

    Plovdiv, Bulgaria

  • Chiesi Site No 116

    Troyan Municipality, Bulgaria

  • Chiesi Site No 117

    Sofia, Bulgaria

  • Chiesi Site No 1201

    Kayseri, Turkey (Türkiye)

  • Chiesi Site No 1202

    Kirikkale, Turkey (Türkiye)

  • Chiesi Site No 1203

    Gaziantep, Turkey (Türkiye)

  • Chiesi Site No 1204

    Aydin, Turkey (Türkiye)

  • Chiesi Site No 1205

    Tokat Province, Turkey (Türkiye)

  • Chiesi Site No 1207

    Konya, Turkey (Türkiye)

  • Chiesi Site No 1208

    Istanbul, Turkey (Türkiye)

  • Chiesi Site No 1209

    Trabzon, Turkey (Türkiye)

  • Chiesi Site No 1210

    Manisa, Turkey (Türkiye)

  • Chiesi Site No 1211

    Malatya, Turkey (Türkiye)

  • Chiesi Site No 1213

    Ankara, Turkey (Türkiye)

  • Chiesi Site No 1214

    Istanbul, Turkey (Türkiye)

  • Chiesi Site No 1215

    Istanbul, Turkey (Türkiye)

  • Chiesi Site No 1216

    Adana, Turkey (Türkiye)

  • Chiesi Site No 1217

    Izmir, Turkey (Türkiye)

  • Chiesi Site No 1301

    Glasgow, United Kingdom

  • Chiesi Site No 1305

    Newcastle, United Kingdom

  • Chiesi Site No 1306

    Hereford, United Kingdom

  • Chiesi Site No 1401

    Kharkiv, Ukraine

  • Chiesi Site No 1402

    Kiev, Ukraine

  • Chiesi Site No 1403

    Kiev, Ukraine

  • Chiesi Site No 1405

    Luhansk, Ukraine

  • Chiesi Site No 1406

    Kharkiv, Ukraine

  • Chiesi Site No 1407

    Kharkiv, Ukraine

  • Chiesi Site No 1408

    Kharkiv, Ukraine

  • Chiesi Site No 1410

    Donetsk, Ukraine

  • Chiesi Site No 1411

    Simferopol, Ukraine

  • Chiesi Site No 1412

    Odesa, Ukraine

  • Chiesi Site No 1417

    Kharkiv, Ukraine

  • Chiesi Site No 1418

    Kharkiv, Ukraine

  • Chiesi Site No 201

    Beroun, Czechia

  • Chiesi Site No 202

    Prague, Czechia

  • Chiesi Site No 203

    Prague, Czechia

  • Chiesi Site No 204

    Prague, Czechia

  • Chiesi Site No 205

    Prague, Czechia

  • Chiesi Site No 206

    Brno, Czechia

  • Chiesi Site No 207

    Brno, Czechia

  • Chiesi Site No 208

    Prague, Czechia

  • Chiesi Site No 301

    Zagreb, Croatia

  • Chiesi Site No 302

    Zagreb, Croatia

  • Chiesi Site No 304

    Rijeka, Croatia

  • Chiesi Site No 305

    Osijek, Croatia

  • Chiesi Site No 306

    Zadar, Croatia

  • Chiesi Site No 307

    Zagreb, Croatia

  • Chiesi Site No 401

    Paris, France

  • Chiesi Site No 402

    Saint-Michel, France

  • Chiesi Site No 403

    Dijon, France

  • Chiesi Site No 404

    Perpignan, France

  • Chiesi Site No 405

    Poitiers, France

  • Chiesi Site No 406

    Soissons, France

  • Chiesi Site No 408

    Hyères, France

  • Chiesi Site No 410

    Marseille, France

  • Chiesi Site No 411

    Saint-Quentin, France

  • Chiesi Site No 414

    Verdun, France

  • Chiesi Site No 416

    Saint-Etienne, France

  • Chiesi Site No 417

    Nice, France

  • Chiesi Site No 418

    Montpellier, France

  • Chiesi Site No 420

    Saint-Girons, France

  • Chiesi Site No 421

    Castelnau-le-Lez, France

  • Chiesi Site No 422

    Toulon, France

  • Chiesi Site No 423

    Paris, France

  • Chiesi Site No 424

    Marmande, France

  • Chiesi Site No 425

    Pézenas, France

  • Chiesi Site No 426

    Ollioules, France

  • Chiesi Site No 428

    Angoulême, France

  • Chiesi Site No 432

    Toulon, France

  • Chiesi Site No 434

    Chauny, France

  • Chiesi Site No 435

    Nîmes, France

  • Chiesi Site No 436

    Marseille, France

  • Chiesi Site No 501

    Weyhe, Germany

  • Chiesi Site No 502

    Dortmund, Germany

  • Chiesi Site No 503

    Frankfurt, Germany

  • Chiesi Site No 504

    Düren, Germany

  • Chiesi Site No 505

    München, Germany

  • Chiesi Site No 506

    Hagen, Germany

  • Chiesi Site No 508

    Koblenz, Germany

  • Chiesi Site No 509

    Koblenz, Germany

  • Chiesi Site No 510

    Cologne, Germany

  • Chiesi Site No 511

    Frankfurt, Germany

  • Chiesi Site No 512

    Ludwigshafen, Germany

  • Chiesi Site No 513

    Hamburg, Germany

  • Chiesi Site No 514

    Bochum, Germany

  • Chiesi Site No 515

    Neuss, Germany

  • Chiesi Site No 516

    Duisburg, Germany

  • Chiesi Site No 518

    Witten, Germany

  • Chiesi Site No 519

    Krefeld, Germany

  • Chiesi Site No 520

    Bonn, Germany

  • Chiesi Site No 601

    Ferrara, Italy

  • Chiesi Site No 602

    Pisa, Italy

  • Chiesi Site No 603

    Palermo, Italy

  • Chiesi Site No 604

    Genova, Italy

  • Chiesi Site No 605

    Genova, Italy

  • Chiesi Site No 606

    Benevento, Italy

  • Chiesi Site No 607

    Crema, Italy

  • Chiesi Site No 608

    Modena, Italy

  • Chiesi Site No 609 "Sesto San Giovanni (MI)"

    Sesto San Giovanni, Italy

  • Chiesi Site No 610

    Foggia, Italy

  • Chiesi Site No 611

    Montescano, Italy

  • Chiesi Site No 612

    Cittadella, Italy

  • Chiesi Site No 613

    Pietra Ligure, Italy

  • Chiesi Site No 614

    Vicenza, Italy

  • Chiesi Site No 615

    Parma, Italy

  • Chiesi Site No 618

    Roma, Italy

  • Chiesi Site No 619

    Impruneta, Italy

  • Chiesi Site No 624

    Palermo, Italy

  • Chiesi Site No 625

    Reggio Calabria, Italy

  • Chiesi Site No 626

    Roma, Italy

  • Chiesi Site No 627

    Milan, Italy

  • Chiesi Site No 628

    Perugia, Italy

  • Chiesi Site No 630

    Palermo, Italy

  • Chiesi Site No 631

    Messina, Italy

  • Chiesi Site No 632

    Castrovillari, Italy

  • Chiesi Site No 633

    Brescia, Italy

  • Chiesi Site No 635

    Naples, Italy

  • Chiesi Site No 636

    Milan, Italy

  • Chiesi Site No 701

    Lodz, Poland

  • Chiesi Site No 702

    Lodz, Poland

  • Chiesi Site No 703

    Lodz, Poland

  • Chiesi Site No 704

    Iława, Poland

  • Chiesi Site No 705

    Katowice, Poland

  • Chiesi Site No 706

    Sucha Beskidzka, Poland

  • Chiesi Site No 707

    Giżycko, Poland

  • Chiesi Site No 708

    Strzelce Opolskie, Poland

  • Chiesi Site No 709

    Gdansk, Poland

  • Chiesi Site No 710

    Starachowice, Poland

  • Chiesi Site No 711

    Krakow, Poland

  • Chiesi Site No 712

    Wroclaw, Poland

  • Chiesi Site No 713

    Lodz, Poland

  • Chiesi Site No 714

    Zabrze, Poland

  • Chiesi Site No 715

    Lubin, Poland

  • Chiesi Site No 716

    Legionowo, Poland

  • Chiesi Site No 717

    Łomża, Poland

  • Chiesi Site No 718

    Lublin, Poland

  • Chiesi Site No 719

    Gdansk, Poland

  • Chiesi Site No 720

    Bialystok, Poland

  • Chiesi Site No 721

    Krakow, Poland

  • Chiesi Site No 722

    Krakow, Poland

  • Chiesi Site No 723

    Lodz, Poland

  • Chiesi Site No 724

    Bialystok, Poland

  • Chiesi Site No 725

    Proszowice, Poland

  • Chiesi Site No 726

    Lodz, Poland

  • Chiesi Site No 727

    Krakow, Poland

  • Chiesi Site No 728

    Krakow, Poland

  • Chiesi Site No 729

    Bielsko-Biala, Poland

  • Chiesi Site No 730

    Lublin, Poland

  • Chiesi Site No 732

    Wilkowice, Poland

  • Chiesi Site No 733

    Wroclaw, Poland

  • Chiesi Site No 735

    Ostróda, Poland

  • Chiesi Site No 736

    Lodz, Poland

  • Chiesi Site No 737

    Rzeszów, Poland

  • Chiesi Site No 738

    Gdynia, Poland

  • Chiesi Site No 739

    Katowice, Poland

  • Chiesi Site No 740

    Lodz, Poland

  • Chiesi Site No 741

    Bialystok, Poland

  • Chiesi Site No 742

    Warsaw, Poland

  • Chiesi Site No 801

    Bucharest, Romania

  • Chiesi Site No 804

    Iași, Romania

  • Chiesi Site No 805

    Brasov, Romania

  • Chiesi Site No 806

    Constanța, Romania

  • Chiesi Site No 807

    Bucharest, Romania

  • Chiesi Site No 808

    Bucharest, Romania

  • Chiesi Site No 810

    Cluj-Napoca, Romania

  • Chiesi Site No 811

    Târgu Mureş, Romania

  • Chiesi Site No 901

    Moscow, Russia

  • Chiesi Site No 902

    Moscow, Russia

  • Chiesi Site No 903

    Moscow, Russia

  • Chiesi Site No 904

    Moscow, Russia

  • Chiesi Site No 905

    Moscow, Russia

  • Chiesi Site No 906

    Moscow, Russia

  • Chiesi Site No 907

    Moscow, Russia

  • Chiesi Site No 908

    Yaroslavl, Russia

  • Chiesi Site No 909

    Yaroslavl, Russia

  • Chiesi Site No 910

    Yaroslavl, Russia

  • Chiesi Site No 911

    Yaroslavl, Russia

  • Chiesi Site No 912

    Yaroslavl, Russia

  • Chiesi Site No 913

    Saratov, Russia

  • Chiesi Site No 914

    Saratov, Russia

  • Chiesi Site No 915

    Ryazan, Russia

  • Chiesi Site No 916

    Moscow, Russia

  • Chiesi Site No 917

    Moscow, Russia

  • Chiesi Site No 918

    Moscow, Russia

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