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NCT00861926

PHASE3

Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)

Sponsor: Chiesi Farmaceutici S.p.A.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1714

Start Date

2009-03-20

Completion Date

2010-12-07

Last Updated

2026-05-07

Healthy Volunteers

Conditions

Asthma

Interventions

DRUG

Salbutamol

Administered via a pressurized metered-dose inhaler

DRUG

Beclomethasone dipropionate + Formoterol

Administered via a pressurized metered-dose inhaler

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.

Locations (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

Clinical Research Directory

Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (206)