Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD
Summary
Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of beclometasone + formoterol + glycopyrrolate (BDP/FF/GB) administered via pressurised metered dose inhaler (pMDI) over the equivalent dose of Foster® (beclometasone dipropionate (BDP) / formoterol fumarate (FF), in patients diagnosed with chronic obstructive pulmonary disease (COPD) after 52 weeks of treatment.
Timeline
- Start
- 2014-03-21
- Primary completion
- 2016-01-14
- Completion
- 2016-01-14
Outcome
Mixed primary results
registry analysis (superiority test); CHF 5993 pMDI vs CHF 1535 pMDI Foster®; p < 0.001; Adjusted mean difference 0.081 (95% CI 0.052 to 0.109) NCT01917331 ↗
registry analysis (superiority test); CHF 5993 pMDI vs CHF 1535 pMDI Foster®; p < 0.001; Adjusted mean difference 0.117 (95% CI 0.086 to 0.147) NCT01917331 ↗
registry analysis (superiority test); CHF 5993 pMDI vs CHF 1535 pMDI Foster®; p = 0.160; Adjusted mean difference 0.21 (95% CI -0.08 to 0.51) NCT01917331 ↗
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 Singh D, Papi A, Corradi M, Pavlisova I, Montagna I, Francisco C, Cohuet G, Vezzoli S, Scuri M, Vestbo J. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting beta2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): a double-blind, parallel group, randomised controlled trial. Lancet. 2016 Sep 3;388(10048):963-73. doi: 10.1016/S0140-6736(16)31354-X. Epub 2016 Sep 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glycopyrrolate | Small molecule | 12.5 ug | Inhaled |
| Background | Beclomethasone | Small molecule | 100 ug | Inhaled |
| Background | Formoterol | Other / unclassified | 6 ug | Inhaled |