drugset / Trial / NCT01313676
Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine if fluticasone furoate/vilanterol improves survival in patients with chronic obstructive pulmonary disease with a history of or increased risk of heart disease.
Timeline
- Start
- 2011-01-25
- Primary completion
- 2015-07-15
- Completion
- 2015-07-15
Outcome
Missed primary endpoint
registry analysis (superiority or other test); Placebo vs Fluticasone Furoate/Vilanterol 100/25 µg; p = 0.137; Hazard Ratio (HR) 0.878 (95% CI 0.739 to 1.042); Cox Proportional Hazards Model NCT01313676 ↗
release “As the primary endpoint of the SUMMIT was not met” gsk.com ↗
Publications
- Verstraete K, Gyselinck I, Huts H, Das N, Topalovic M, De Vos M, Janssens W. Estimating individual treatment effects on COPD exacerbations by causal machine learning on randomised controlled trials. Thorax. 2023 Oct;78(10):983-989. doi: 10.1136/thorax-2022-219382. Epub 2023 Apr 3.
- Horne BD, Hegewald MJ, Crim C, Rea S, Bair TL, Blagev DP. The Summit Score Stratifies Mortality and Morbidity in Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 Jul 20;15:1741-1750. doi: 10.2147/COPD.S254437. eCollection 2020.
- Wise RA, Anderson JA, Amarenco P, Cowans NJ, Crim C, Denvir MA, Gomez CR, Jones MP, Morris A, Niewoehner D, Yates JC. Adjudication of cardiovascular events in patients with chronic obstructive pulmonary disease: SUMMIT trial. Clin Trials. 2020 Aug;17(4):430-436. doi: 10.1177/1740774520920897. Epub 2020 May 22.
- Celli BR, Anderson JA, Brook R, Calverley P, Cowans NJ, Crim C, Dixon I, Kim V, Martinez FJ, Morris A, Newby DE, Yates J, Vestbo J. Serum biomarkers and outcomes in patients with moderate COPD: a substudy of the randomised SUMMIT trial. BMJ Open Respir Res. 2019 May 4;6(1):e000431. doi: 10.1136/bmjresp-2019-000431. eCollection 2019.
- Fawzy A, Anderson JA, Cowans NJ, Crim C, Wise R, Yates JC, Hansel NN. Association of platelet count with all-cause mortality and risk of cardiovascular and respiratory morbidity in stable COPD. Respir Res. 2019 May 8;20(1):86. doi: 10.1186/s12931-019-1059-1.
- Vestbo J, Dransfield M, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez F, Newby DE, Yates J, Lange P. Impact of pre-enrolment medication use on clinical outcomes in SUMMIT. ERJ Open Res. 2019 Feb 25;5(1):00203-2018. doi: 10.1183/23120541.00203-2018. eCollection 2019 Feb.
- Adamson PD, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Dixon IJ, Martinez FJ, Newby DE, Vestbo J, Yates JC, Mills NL. Cardiac Troponin I and Cardiovascular Risk in Patients With Chronic Obstructive Pulmonary Disease. J Am Coll Cardiol. 2018 Sep 4;72(10):1126-1137. doi: 10.1016/j.jacc.2018.06.051.
- Kunisaki KM, Dransfield MT, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Hartley BF, Martinez FJ, Newby DE, Pragman AA, Vestbo J, Yates JC, Niewoehner DE; SUMMIT Investigators. Exacerbations of Chronic Obstructive Pulmonary Disease and Cardiac Events. A Post Hoc Cohort Analysis from the SUMMIT Randomized Clinical Trial. Am J Respir Crit Care Med. 2018 Jul 1;198(1):51-57. doi: 10.1164/rccm.201711-2239OC.
- Celli B, Anderson JA, Brook R, Calverley P, Crim C, Holmes AP, Martinez FJ, Newby DE, Yates J, Vestbo J; SUMMIT Investigators. Long-Acting beta-Agonist/Inhaled Corticosteroid in Patients with Chronic Obstructive Pulmonary Disease with Cardiovascular Disease or Risk: A Factorial Analysis of the SUMMIT Clinical Trial. Am J Respir Crit Care Med. 2018 Jun 15;197(12):1641-1644. doi: 10.1164/rccm.201710-2052LE. No abstract available.
- Dransfield MT, McAllister DA, Anderson JA, Brook RD, Calverley PMA, Celli BR, Crim C, Gallot N, Martinez FJ, Scanlon PD, Yates J, Vestbo J, Newby DE; SUMMIT Investigators. beta-Blocker Therapy and Clinical Outcomes in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. An Observational Substudy of SUMMIT. Ann Am Thorac Soc. 2018 May;15(5):608-614. doi: 10.1513/AnnalsATS.201708-626OC.
- Bhatt SP, Anderson JA, Brook RD, Calverley PMA, Celli BR, Cowans NJ, Crim C, Martinez FJ, Newby DE, Vestbo J, Yates JC, Dransfield MT. Cigarette smoking and response to inhaled corticosteroids in COPD. Eur Respir J. 2018 Jan 18;51(1):1701393. doi: 10.1183/13993003.01393-2017. Print 2018 Jan. No abstract available.
- Crim C, Calverley PMA, Anderson JA, Holmes AP, Kilbride S, Martinez FJ, Brook RD, Newby DE, Yates JC, Celli BR, Vestbo J; SUMMIT investigators. Pneumonia risk with inhaled fluticasone furoate and vilanterol in COPD patients with moderate airflow limitation: The SUMMIT trial. Respir Med. 2017 Oct;131:27-34. doi: 10.1016/j.rmed.2017.07.060. Epub 2017 Aug 1.
- Calverley PMA, Anderson JA, Brook RD, Crim C, Gallot N, Kilbride S, Martinez FJ, Yates J, Newby DE, Vestbo J, Wise R, Celli BR; SUMMIT (Study to Understand Mortality and Morbidity) Investigators. Fluticasone Furoate, Vilanterol, and Lung Function Decline in Patients with Moderate Chronic Obstructive Pulmonary Disease and Heightened Cardiovascular Risk. Am J Respir Crit Care Med. 2018 Jan 1;197(1):47-55. doi: 10.1164/rccm.201610-2086OC.
- Brook RD, Anderson JA, Calverley PM, Celli BR, Crim C, Denvir MA, Magder S, Martinez FJ, Rajagopalan S, Vestbo J, Yates J, Newby DE; SUMMIT Investigators. Cardiovascular outcomes with an inhaled beta2-agonist/corticosteroid in patients with COPD at high cardiovascular risk. Heart. 2017 Oct;103(19):1536-1542. doi: 10.1136/heartjnl-2016-310897. Epub 2017 Apr 17.
- Martinez FJ, Vestbo J, Anderson JA, Brook RD, Celli BR, Cowans NJ, Crim C, Dransfield M, Kilbride S, Yates J, Newby DE, Niewoehner D, Calverley PM; SUMMIT Investigators. Effect of Fluticasone Furoate and Vilanterol on Exacerbations of Chronic Obstructive Pulmonary Disease in Patients with Moderate Airflow Obstruction. Am J Respir Crit Care Med. 2017 Apr 1;195(7):881-888. doi: 10.1164/rccm.201607-1421OC.
- Vestbo J, Anderson JA, Brook RD, Calverley PM, Celli BR, Crim C, Martinez F, Yates J, Newby DE; SUMMIT Investigators. Fluticasone furoate and vilanterol and survival in chronic obstructive pulmonary disease with heightened cardiovascular risk (SUMMIT): a double-blind randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1817-26. doi: 10.1016/S0140-6736(16)30069-1. Epub 2016 Apr 28.
- Vestbo J, Anderson J, Brook RD, Calverley PM, Celli BR, Crim C, Haumann B, Martinez FJ, Yates J, Newby DE. The Study to Understand Mortality and Morbidity in COPD (SUMMIT) study protocol. Eur Respir J. 2013 May;41(5):1017-22. doi: 10.1183/09031936.00087312. Epub 2012 Sep 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone Furoate | Other / unclassified | 100 ug | Inhaled |
| Subject | Vilanterol | Other / unclassified | 25 ug | Inhaled |