Efficacy and Safety of ICS/LABA vs. LAMA/LABA in Patients With Different COPD Phenotypes.

Summary

This is a randomized, blinded, controlled clinical trial for mexican COPD patients. Biomass smoke associated COPD (BS-COPD) clinical spectrum is different to the one seen in tobacco smoke associated COPD (TS-COPD). BS-COPD patients present COPD-asthma phenotype or asthma-COPD overlap syndrome (ACOS), TS-COPD patients present mostly the emphysema phenotype. BS-COPD patients have a greater risk of exacerbations in comparison to the emphysema phenotype. Therefore, individualizing treatment in both phenotypes may be very useful among the clinical practitioners. The investigators expect treatment with FF/V to be superior in preventing COPD exacerbations than the U/V combination in patients with COPD-asthma phenotype; andU/V to be superior than FF/V in patients with the emphysema phenotype. The general objective of the study is to determine the exacerbations outcome in patients with COPD-asthma vs emphysema phenotype patients, treated with both drugs. Secondary objectives include assessment of pulmonary function tests, quality of life, dyspnea and functional capacity change after a 24 weeks treatment.

Timeline

Start

2017-09-19

Primary completion

2020-11-19

Completion

2021-02-01

Publications

• Background Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.
• Background Camp PG, Ramirez-Venegas A, Sansores RH, Alva LF, McDougall JE, Sin DD, Pare PD, Muller NL, Silva CI, Rojas CE, Coxson HO. COPD phenotypes in biomass smoke- versus tobacco smoke-exposed Mexican women. Eur Respir J. 2014 Mar;43(3):725-34. doi: 10.1183/09031936.00206112. Epub 2013 Oct 10.
• Background Lopez Varela MV, Muino A, Perez Padilla R, Jardim JR, Talamo C, Montes de Oca M, Valdivia G, Pertuze J, Halbert R, Menezes AM; PLATINO Group. [Treatment of chronic obstructive pulmonary disease in 5 Latin American cities: the PLATINO study]. Arch Bronconeumol. 2008 Feb;44(2):58-64. doi: 10.1016/s1579-2129(08)60016-6. Spanish.
• Background Caballero A, Torres-Duque CA, Jaramillo C, Bolivar F, Sanabria F, Osorio P, Orduz C, Guevara DP, Maldonado D. Prevalence of COPD in five Colombian cities situated at low, medium, and high altitude (PREPOCOL study). Chest. 2008 Feb;133(2):343-9. doi: 10.1378/chest.07-1361. Epub 2007 Oct 20.
• Background Ramirez-Venegas A, Sansores RH, Quintana-Carrillo RH, Velazquez-Uncal M, Hernandez-Zenteno RJ, Sanchez-Romero C, Velazquez-Montero A, Flores-Trujillo F. FEV1 decline in patients with chronic obstructive pulmonary disease associated with biomass exposure. Am J Respir Crit Care Med. 2014 Nov 1;190(9):996-1002. doi: 10.1164/rccm.201404-0720OC.
• Background Bruce N, Perez-Padilla R, Albalak R. Indoor air pollution in developing countries: a major environmental and public health challenge. Bull World Health Organ. 2000;78(9):1078-92.
• Background Regalado J, Perez-Padilla R, Sansores R, Paramo Ramirez JI, Brauer M, Pare P, Vedal S. The effect of biomass burning on respiratory symptoms and lung function in rural Mexican women. Am J Respir Crit Care Med. 2006 Oct 15;174(8):901-5. doi: 10.1164/rccm.200503-479OC. Epub 2006 Jun 23.
• Background Moran-Mendoza O, Perez-Padilla JR, Salazar-Flores M, Vazquez-Alfaro F. Wood smoke-associated lung disease: a clinical, functional, radiological and pathological description. Int J Tuberc Lung Dis. 2008 Sep;12(9):1092-8.
• Background Rivera RM, Cosio MG, Ghezzo H, Salazar M, Perez-Padilla R. Comparison of lung morphology in COPD secondary to cigarette and biomass smoke. Int J Tuberc Lung Dis. 2008 Aug;12(8):972-7.
• Background Usmani OS, Barnes PJ. Assessing and treating small airways disease in asthma and chronic obstructive pulmonary disease. Ann Med. 2012 Mar;44(2):146-56. doi: 10.3109/07853890.2011.585656. Epub 2011 Jun 17.
• Background Vestbo J; TORCH Study Group. The TORCH (towards a revolution in COPD health) survival study protocol. Eur Respir J. 2004 Aug;24(2):206-10. doi: 10.1183/09031936.04.00120603.
• Background Celli B, Decramer M, Kesten S, Liu D, Mehra S, Tashkin DP; UPLIFT Study Investigators. Mortality in the 4-year trial of tiotropium (UPLIFT) in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Nov 15;180(10):948-55. doi: 10.1164/rccm.200906-0876OC. Epub 2009 Sep 3.
• Background Bujarski S, Parulekar AD, Sharafkhaneh A, Hanania NA. The asthma COPD overlap syndrome (ACOS). Curr Allergy Asthma Rep. 2015 Mar;15(3):509. doi: 10.1007/s11882-014-0509-6.
• Background Brzostek D, Kokot M. Asthma-chronic obstructive pulmonary disease overlap syndrome in Poland. Findings of an epidemiological study. Postepy Dermatol Alergol. 2014 Dec;31(6):372-9. doi: 10.5114/pdia.2014.47120. Epub 2014 Dec 3.
• Background Al-Kassimi FA, Alhamad EH, Al-Hajjaj MS, Raddaoui E, Alzeer AH, Alboukai AA, Somily AM, Cal JG, Ibrahim AF, Shaik SA. Can computed tomography and carbon monoxide transfer coefficient diagnose an asthma-like phenotype in COPD? Respirology. 2017 Feb;22(2):322-328. doi: 10.1111/resp.12902. Epub 2016 Sep 13.
• Background Golpe R, Sanjuan Lopez P, Cano Jimenez E, Castro Anon O, Perez de Llano LA. Distribution of clinical phenotypes in patients with chronic obstructive pulmonary disease caused by biomass and tobacco smoke. Arch Bronconeumol. 2014 Aug;50(8):318-24. doi: 10.1016/j.arbres.2013.12.013. Epub 2014 Feb 25. English, Spanish.
• Background Wedzicha JA, Banerji D, Chapman KR, Vestbo J, Roche N, Ayers RT, Thach C, Fogel R, Patalano F, Vogelmeier CF; FLAME Investigators. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med. 2016 Jun 9;374(23):2222-34. doi: 10.1056/NEJMoa1516385. Epub 2016 May 15.
• Background Zach JA, Newell JD Jr, Schroeder J, Murphy JR, Curran-Everett D, Hoffman EA, Westgate PM, Han MK, Silverman EK, Crapo JD, Lynch DA; COPDGene Investigators. Quantitative computed tomography of the lungs and airways in healthy nonsmoking adults. Invest Radiol. 2012 Oct;47(10):596-602. doi: 10.1097/RLI.0b013e318262292e.
• Background Miravitlles M, Calle M, Soler-Cataluna JJ. Clinical phenotypes of COPD: identification, definition and implications for guidelines. Arch Bronconeumol. 2012 Mar;48(3):86-98. doi: 10.1016/j.arbres.2011.10.007. Epub 2011 Dec 22. English, Spanish.
• Background Cosio BG, Soriano JB, Lopez-Campos JL, Calle-Rubio M, Soler-Cataluna JJ, de-Torres JP, Marin JM, Martinez-Gonzalez C, de Lucas P, Mir I, Peces-Barba G, Feu-Collado N, Solanes I, Alfageme I, Casanova C; CHAIN Study. Defining the Asthma-COPD Overlap Syndrome in a COPD Cohort. Chest. 2016 Jan;149(1):45-52. doi: 10.1378/chest.15-1055. Epub 2016 Jan 6.

Drugs

Indications