drugset / Trial / NCT01911364
Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease)
Timeline
- Start
- 2014-01
- Primary completion
- 2016-03
- Completion
- 2016-03
Publications
- Background Vanfleteren L, Fabbri LM, Papi A, Petruzzelli S, Celli B. Triple therapy (ICS/LABA/LAMA) in COPD: time for a reappraisal. Int J Chron Obstruct Pulmon Dis. 2018 Dec 12;13:3971-3981. doi: 10.2147/COPD.S185975. eCollection 2018.
- Background Singh D, Fabbri LM, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA. Int J Chron Obstruct Pulmon Dis. 2019 Feb 28;14:531-546. doi: 10.2147/COPD.S196383. eCollection 2019.
- Background Singh D, Fabbri LM, Corradi M, Georges G, Guasconi A, Vezzoli S, Petruzzelli S, Papi A. Extrafine triple therapy in patients with symptomatic COPD and history of one moderate exacerbation. Eur Respir J. 2019 May 18;53(5):1900235. doi: 10.1183/13993003.00235-2019. Print 2019 May.
- Results Vestbo J, Papi A, Corradi M, Blazhko V, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Singh D. Single inhaler extrafine triple therapy versus long-acting muscarinic antagonist therapy for chronic obstructive pulmonary disease (TRINITY): a double-blind, parallel group, randomised controlled trial. Lancet. 2017 May 13;389(10082):1919-1929. doi: 10.1016/S0140-6736(17)30188-5. Epub 2017 Apr 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Formoterol | Other / unclassified | 6 ug | Inhaled |
| Subject | Glycopyrronium | Unknown | 12.5 ug | Inhaled |
| Comparator | Tiotropium | Other / unclassified | 18 ug | Inhaled |
| Subject | beclomethasone dipropionate | Other / unclassified | 100 ug | Inhaled |