Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)
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.
Timeline
- Start
- 2009-03-20
- Primary completion
- 2010-12-07
- Completion
- 2010-12-07
Outcome
Met primary endpoint
paper significantly increased the time to first exacerbation (209 days vs 134 days) by 75 days, with a 36% reduction in risk PMID 24321801 ↗
registry analysis (superiority test); Treatment A vs Treatment B; p <0.001; Hazard Ratio (HR) 0.636 (95% CI 0.494 to 0.820); Cox proportional hazards model NCT00861926 ↗
Publications
- Results 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.
- Morjaria 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Beclomethasone | Small molecule | 100 ug | Inhaled |
| Subject | Formoterol | Other / unclassified | 6 ug | Inhaled |
| Comparator | Salbutamol | Unknown | 100 ug | Inhaled |