Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)
48-week, Multicentre, Multinational, Randomized, Double-blind, 2-arm Parallel Group, Comparing the Efficacy of FOSTER for Maintenance & Reliever Versus Fixed-dose FOSTER for Maintenance + Salbutamol as Reliever in Asthmatics ≥ 18 Years of Age
2 other identifiers
interventional
1,714
14 countries
206
Brief Summary
Primary objective: The primary objective of the study was to compare the efficacy of Maintenance and Reliever Therapy (MART) with Foster® 100/6 μg (one inhalation bid) plus additional inhalations as needed, with the standard treatment of Foster® 100/6 μg (one inhalation bid) plus salbutamol 100 μg (Ventolin ®) additional inhalations as needed in not fully controlled asthmatic patients. Secondary objectives: The secondary objectives of the study were:
- to evaluate the effect of treatments on lung function parameters and on other clinical outcome measures, and
- to assess the safety and the tolerability of Foster® as MART.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Mar 2009
206 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2009
CompletedFirst Posted
Study publicly available on registry
March 16, 2009
CompletedStudy Start
First participant enrolled
March 20, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 7, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 7, 2010
CompletedResults Posted
Study results publicly available
May 7, 2026
CompletedMay 7, 2026
April 1, 2026
1.7 years
March 13, 2009
January 15, 2026
April 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to First Severe Asthma Exacerbation
A severe asthma exacerbation was defined as asthma worsening resulting in hospitalization or emergency room treatment due to asthma worsening, or the need for systemic steroids for ≥ 3 days because of asthma. First severe asthma exacerbation occurred after the first dose of randomised study drug and within end of study was considered for the analysis. Patients without a severe asthma exacerbation or withdrawn before having it, are considered as 'censored' at the last day in the study or at the time of the withdrawal. Since the median time (50th percentile) and the other key percentiles (25th and 75th) were not reached, the median time of first exacerbation is not available (N.A.). So, to provide meaningful information, the cumulative number of patients who experienced a severe exacerbation at the end of each time period was reported separately.
From First IMP dose to week 48 (EOT)
Cumulative Number of Patients With Severe Asthma Exacerbation by Inter-visit (Measured in Weeks)
A severe asthma exacerbation was defined as asthma worsening resulting in hospitalization or emergency room treatment due to asthma worsening, or the need for systemic steroids for ≥ 3 days because of asthma. First severe asthma exacerbation occurred after the first dose of randomised study drug and within end of study was considered for the analysis. Patients without a severe asthma exacerbation or withdrawn before having it, are considered as 'censored' at the last day in the study or at the time of the withdrawal. As already anticipated in the primary endpoint, since the median time (50th percentile) and the other key percentiles (25th and 75th) were not reached, and the median time of first exacerbation is not available (N.A.), to provide meaningful information, the cumulative number of patients who experienced a severe exacerbation at the end of each time period is here reported.
From First dose to end of each interval: 0-4, 4-12, 12-24, 24-36, 36-48 weeks
Secondary Outcomes (18)
Number of Severe Asthma Exacerbations Per 100 Patients Per Year
First dose to end of the study (Up to 48 Weeks)
Number of Systemic Corticosteroids Courses to Treat Asthma Per 100 Patients Per Year
First dose to end of the study (Up to 48 Weeks)
Number of Hospitalisation/Emergency Room Treatments Due to Asthma Per 100 Patients Per Year
From first dose to end of the study (Up to Week 48)
Change From Baseline in Asthma Control Questionnaire (ACQ) Score to Each Visit
Week 4 (V3), Week 12 (V4), Week 24 (V5), Week 36 (V6), Week 48 (V7)
Number of Mild Asthma Exacerbations Per 100 Patients / Year
From first dose through end of the study (Up to Week 48)
- +13 more secondary outcomes
Study Arms (2)
Foster (Treatment A)
EXPERIMENTALParticipants received one inhalation of Foster (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) administered via a pMDI, BID, as maintenance therapy and additional inhalations of Foster (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) as needed in response to symptoms as reliever therapy. A maximum of 6 inhalations per day was allowed as reliever therapy. To ensure blinding, participants received inhalations of placebo matching Ventolin as reliever therapy. Participants received treatment for a duration of 48 weeks.
Foster + Ventolin (Treatment B)
ACTIVE COMPARATORParticipants received one inhalation of Foster (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose) administered via a pMDI, BID, as maintenance therapy and additional inhalations of Ventolin (Salbutamol, 100 μg per metered dose) as needed in response to symptoms as reliever therapy. A maximum of 6 inhalations per day was allowed as reliever therapy. To ensure blinding, participants received inhalations of placebo matching Foster as reliever therapy. Participants received treatment for a duration of 48 weeks.
Interventions
Administered via a pressurized metered-dose inhaler
Administered via a pressurized metered-dose inhaler
Eligibility Criteria
You may qualify if:
- Written signed and dated informed consent obtained from patient;
- Male or female patients aged ≥ 18 years;
- Clinical diagnosis of asthma for ≥ 6 months;
- 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;
- 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;
- 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.
- 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.
- +7 more criteria
You may not qualify if:
- 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:
- Surgical sterilization (e.g. bilateral tubal ligation, hysterectomy);
- Hormonal contraception (implantable, patch, oral);
- 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;
- Body Mass Index (BMI) \> 34 kg/m2;
- Patients with lower respiratory tract infections affecting the patient's asthma within 30 days of the screening visit;
- Use of systemic steroids in the last month;
- 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;
- 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;
- History or current evidence of uncontrolled heart failure, clinically relevant coronary artery disease, recent myocardial infarction, severe hypertension, uncontrolled cardiac arrhythmias;
- Cancer or any other chronic disease with poor prognosis (less than 2 years) and /or affecting patient status;
- 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;
- 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);
- Intolerance or contra-indication to treatment with β2-agonists and/or ICS or allergy to any component of the study treatments;
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (206)
Chiesi Site No 103
Burgas, Bulgaria
Chiesi Site No 107
Pleven, Bulgaria
Chiesi Site No 105
Plovdiv, Bulgaria
Chiesi Site No 111
Plovdiv, Bulgaria
Chiesi Site No 115
Plovdiv, Bulgaria
Chiesi Site No 102
Rousse, Bulgaria
Chiesi Site No 104
Sofia, Bulgaria
Chiesi Site No 108
Sofia, Bulgaria
Chiesi Site No 109
Sofia, Bulgaria
Chiesi Site No 110
Sofia, Bulgaria
Chiesi Site No 113
Sofia, Bulgaria
Chiesi Site No 117
Sofia, Bulgaria
Chiesi Site No 106
Stara Zagora, Bulgaria
Chiesi Site No 116
Troyan Municipality, Bulgaria
Chiesi Site No 0101
Varna, Bulgaria
Chiesi Site No 112
Veliko Tarnovo, Bulgaria
Chiesi Site No 305
Osijek, Croatia
Chiesi Site No 304
Rijeka, Croatia
Chiesi Site No 306
Zadar, Croatia
Chiesi Site No 301
Zagreb, Croatia
Chiesi Site No 302
Zagreb, Croatia
Chiesi Site No 307
Zagreb, Croatia
Chiesi Site No 201
Beroun, Czechia
Chiesi Site No 206
Brno, Czechia
Chiesi Site No 207
Brno, 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 208
Prague, Czechia
Chiesi Site No 428
Angoulême, France
Chiesi Site No 421
Castelnau-le-Lez, France
Chiesi Site No 434
Chauny, France
Chiesi Site No 403
Dijon, France
Chiesi Site No 408
Hyères, France
Chiesi Site No 424
Marmande, France
Chiesi Site No 410
Marseille, France
Chiesi Site No 436
Marseille, France
Chiesi Site No 418
Montpellier, France
Chiesi Site No 417
Nice, France
Chiesi Site No 435
Nîmes, France
Chiesi Site No 426
Ollioules, France
Chiesi Site No 401
Paris, France
Chiesi Site No 423
Paris, France
Chiesi Site No 404
Perpignan, France
Chiesi Site No 425
Pézenas, France
Chiesi Site No 405
Poitiers, France
Chiesi Site No 416
Saint-Etienne, France
Chiesi Site No 420
Saint-Girons, France
Chiesi Site No 402
Saint-Michel, France
Chiesi Site No 411
Saint-Quentin, France
Chiesi Site No 406
Soissons, France
Chiesi Site No 422
Toulon, France
Chiesi Site No 432
Toulon, France
Chiesi Site No 414
Verdun, France
Chiesi Site No 514
Bochum, Germany
Chiesi Site No 520
Bonn, Germany
Chiesi Site No 510
Cologne, Germany
Chiesi Site No 502
Dortmund, Germany
Chiesi Site No 516
Duisburg, Germany
Chiesi Site No 504
Düren, Germany
Chiesi Site No 503
Frankfurt, Germany
Chiesi Site No 511
Frankfurt, Germany
Chiesi Site No 506
Hagen, Germany
Chiesi Site No 513
Hamburg, Germany
Chiesi Site No 508
Koblenz, Germany
Chiesi Site No 509
Koblenz, Germany
Chiesi Site No 519
Krefeld, Germany
Chiesi Site No 512
Ludwigshafen, Germany
Chiesi Site No 505
München, Germany
Chiesi Site No 515
Neuss, Germany
Chiesi Site No 501
Weyhe, Germany
Chiesi Site No 518
Witten, Germany
Chiesi Site No 606
Benevento, Italy
Chiesi Site No 633
Brescia, Italy
Chiesi Site No 632
Castrovillari, Italy
Chiesi Site No 612
Cittadella, Italy
Chiesi Site No 607
Crema, Italy
Chiesi Site No 601
Ferrara, Italy
Chiesi Site No 610
Foggia, Italy
Chiesi Site No 604
Genova, Italy
Chiesi Site No 605
Genova, Italy
Chiesi Site No 619
Impruneta, Italy
Chiesi Site No 631
Messina, Italy
Chiesi Site No 627
Milan, Italy
Chiesi Site No 636
Milan, Italy
Chiesi Site No 608
Modena, Italy
Chiesi Site No 611
Montescano, Italy
Chiesi Site No 635
Naples, Italy
Chiesi Site No 603
Palermo, Italy
Chiesi Site No 624
Palermo, Italy
Chiesi Site No 630
Palermo, Italy
Chiesi Site No 615
Parma, Italy
Chiesi Site No 628
Perugia, Italy
Chiesi Site No 613
Pietra Ligure, Italy
Chiesi Site No 602
Pisa, Italy
Chiesi Site No 625
Reggio Calabria, Italy
Chiesi Site No 618
Roma, Italy
Chiesi Site No 626
Roma, Italy
Chiesi Site No 609 "Sesto San Giovanni (MI)"
Sesto San Giovanni, Italy
Chiesi Site No 614
Vicenza, Italy
Chiesi Site No 720
Bialystok, Poland
Chiesi Site No 724
Bialystok, Poland
Chiesi Site No 741
Bialystok, Poland
Chiesi Site No 729
Bielsko-Biala, Poland
Chiesi Site No 709
Gdansk, Poland
Chiesi Site No 719
Gdansk, Poland
Chiesi Site No 738
Gdynia, Poland
Chiesi Site No 707
Giżycko, Poland
Chiesi Site No 704
Iława, Poland
Chiesi Site No 705
Katowice, Poland
Chiesi Site No 739
Katowice, Poland
Chiesi Site No 711
Krakow, Poland
Chiesi Site No 721
Krakow, Poland
Chiesi Site No 722
Krakow, Poland
Chiesi Site No 727
Krakow, Poland
Chiesi Site No 728
Krakow, Poland
Chiesi Site No 716
Legionowo, Poland
Chiesi Site No 701
Lodz, Poland
Chiesi Site No 702
Lodz, Poland
Chiesi Site No 703
Lodz, Poland
Chiesi Site No 713
Lodz, Poland
Chiesi Site No 723
Lodz, Poland
Chiesi Site No 726
Lodz, Poland
Chiesi Site No 736
Lodz, Poland
Chiesi Site No 740
Lodz, Poland
Chiesi Site No 715
Lubin, Poland
Chiesi Site No 718
Lublin, Poland
Chiesi Site No 730
Lublin, Poland
Chiesi Site No 735
Ostróda, Poland
Chiesi Site No 725
Proszowice, Poland
Chiesi Site No 737
Rzeszów, Poland
Chiesi Site No 710
Starachowice, Poland
Chiesi Site No 708
Strzelce Opolskie, Poland
Chiesi Site No 706
Sucha Beskidzka, Poland
Chiesi Site No 742
Warsaw, Poland
Chiesi Site No 732
Wilkowice, Poland
Chiesi Site No 712
Wroclaw, Poland
Chiesi Site No 733
Wroclaw, Poland
Chiesi Site No 714
Zabrze, Poland
Chiesi Site No 717
Łomża, Poland
Chiesi Site No 805
Brasov, Romania
Chiesi Site No 801
Bucharest, Romania
Chiesi Site No 807
Bucharest, Romania
Chiesi Site No 808
Bucharest, Romania
Chiesi Site No 810
Cluj-Napoca, Romania
Chiesi Site No 806
Constanța, Romania
Chiesi Site No 804
Iași, 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 916
Moscow, Russia
Chiesi Site No 917
Moscow, Russia
Chiesi Site No 918
Moscow, Russia
Chiesi Site No 915
Ryazan, Russia
Chiesi Site No 913
Saratov, Russia
Chiesi Site No 914
Saratov, 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 1001
Belgrade, Serbia
Chiesi Site No 1003
Belgrade, Serbia
Chiesi Site No 1002
Kamenitz, Serbia
Chiesi Site No 1004
Kragujevac, Serbia
Chiesi Site No 1005
Niš, Serbia
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 1216
Adana, Turkey (Türkiye)
Chiesi Site No 1213
Ankara, Turkey (Türkiye)
Chiesi Site No 1204
Aydin, Turkey (Türkiye)
Chiesi Site No 1203
Gaziantep, Turkey (Türkiye)
Chiesi Site No 1208
Istanbul, Turkey (Türkiye)
Chiesi Site No 1214
Istanbul, Turkey (Türkiye)
Chiesi Site No 1215
Istanbul, Turkey (Türkiye)
Chiesi Site No 1217
Izmir, Turkey (Türkiye)
Chiesi Site No 1201
Kayseri, Turkey (Türkiye)
Chiesi Site No 1202
Kirikkale, Turkey (Türkiye)
Chiesi Site No 1207
Konya, Turkey (Türkiye)
Chiesi Site No 1211
Malatya, Turkey (Türkiye)
Chiesi Site No 1210
Manisa, Turkey (Türkiye)
Chiesi Site No 1205
Tokat Province, Turkey (Türkiye)
Chiesi Site No 1209
Trabzon, Turkey (Türkiye)
Chiesi Site No 1410
Donetsk, Ukraine
Chiesi Site No 1401
Kharkiv, Ukraine
Chiesi Site No 1406
Kharkiv, Ukraine
Chiesi Site No 1407
Kharkiv, Ukraine
Chiesi Site No 1408
Kharkiv, Ukraine
Chiesi Site No 1417
Kharkiv, Ukraine
Chiesi Site No 1418
Kharkiv, Ukraine
Chiesi Site No 1402
Kiev, Ukraine
Chiesi Site No 1403
Kiev, Ukraine
Chiesi Site No 1405
Luhansk, Ukraine
Chiesi Site No 1412
Odesa, Ukraine
Chiesi Site No 1411
Simferopol, Ukraine
Chiesi Site No 1301
Glasgow, United Kingdom
Chiesi Site No 1306
Hereford, United Kingdom
Chiesi Site No 1305
Newcastle, United Kingdom
Related Publications (2)
Papi A, Corradi M, Pigeon-Francisco C, Baronio R, Siergiejko Z, Petruzzelli S, Fabbri LM, Rabe KF. Beclometasone-formoterol as maintenance and reliever treatment in patients with asthma: a double-blind, randomised controlled trial. Lancet Respir Med. 2013 Mar;1(1):23-31. doi: 10.1016/S2213-2600(13)70012-2. Epub 2013 Mar 4.
PMID: 24321801RESULTMorjaria JB, Rigby AS, Morice AH. Symptoms and exacerbations in asthma: an apparent paradox? Ther Adv Chronic Dis. 2019 Oct 24;10:2040622319884387. doi: 10.1177/2040622319884387. eCollection 2019.
PMID: 31695864DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Trial INFO
- Organization
- Chiesi Farmaceutici SpA
Study Officials
- PRINCIPAL INVESTIGATOR
Alberto Papi, Professor
Universita degli Studi di Ferrara
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2009
First Posted
March 16, 2009
Study Start
March 20, 2009
Primary Completion
December 7, 2010
Study Completion
December 7, 2010
Last Updated
May 7, 2026
Results First Posted
May 7, 2026
Record last verified: 2026-04