Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED)
Summary
This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg BID for 2 to 3 weeks during the run-in period. Efficacy will be measured by the area under the curve from 0 to 12 hours \[AUC\](0-12 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).
Timeline
- Start
- 2006-07-01
- Primary completion
- 2008-01-01
- Completion
- 2008-01-01
Outcome
Met primary endpoint
paper MF/F 400/10 microg (4.19 L x hour) versus MF 400 microg (2.04 L x hour; p < 0.001). PMID 20687982 ↗
registry analysis (unspecified test); MF/F MDI 400/10 mcg BID vs MF MDI 400 mcg BID; p <0.001; ANCOVA NCT00381485 ↗
registry analysis (unspecified test); MF/F MDI 200/10 mcg BID vs MF MDI 400 mcg BID; p <0.001; ANCOVA NCT00381485 ↗
Publications
- Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
- Weinstein SF, Corren J, Murphy K, Nolte H, White M; Study Investigators of P04431. Twelve-week efficacy and safety study of mometasone furoate/formoterol 200/10 microg and 400/10 microg combination treatments in patients with persistent asthma previously receiving high-dose inhaled corticosteroids. Allergy Asthma Proc. 2010 Jul-Aug;31(4):280-9. doi: 10.2500/aap.2010.31.3381. Epub 2010 Aug 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Formoterol | Other / unclassified | 10 ug | Inhaled |
| Subject | Mometasone furoate | Other / unclassified | 200 ug | Inhaled |
| Subject | Mometasone furoate | Other / unclassified | 400 ug | Inhaled |