Effect of the Inhaled Triple Therapies Over the Small Airway in Biomass Exposure

Summary

This phase IV randomized controlled clinical trial intend to compare the effect of three close standard inhaled triple therapies and one close standard inhaled double therapy on the small airway in patients with Chronic Obstructive Pulmonary Disease (COPD-B) and chronic bronchitis without obstruction (BCNO) exposed to wood smoke. The treatment phase duration is of 3 months. As primary outcome, the resistance change in post-bronchodilatator impulse oscilometry will me measure at 30 minutes, 2 hours, 4 hours, and 24 hours post first dose of the asigned medication, and then at 1 and 3 months of treatment. As secondary outcomes, change in respiratory symptoms and health related quality of life will be assess after 1 and 3 months of treatment.

Timeline

Start

2023-11-15

Primary completion

2025-01-15

Completion

2025-01-15

Publications

• Background Perez-Padilla R, Regalado J, Vedal S, Pare P, Chapela R, Sansores R, Selman M. Exposure to biomass smoke and chronic airway disease in Mexican women. A case-control study. Am J Respir Crit Care Med. 1996 Sep;154(3 Pt 1):701-6. doi: 10.1164/ajrccm.154.3.8810608.
• 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 García-Ochoa R, Rivera-Castañeda P, Bracamonte-Sierra Á. Desigualdad social en torno al uso de tecnologías energéticamente eficientes en México. El caso de la política de normalización de refrigeradores. Estudios Sociales; 29. Epub ahead of print 16 June 2019. DOI: 10.24836/es.v29153.722.
• Background Luo B, Niu .J Short-term effects of rural indoor air pollution on respiratory health and urine biomarkers of college students in the northwestern China. ISEE Conference Abstracts 2020; 2020: isee.2020.virtual.P-1226.
• Background GOLD. GLOBAL STRATEGY FOR PREVENTION, DIAGNOSIS AND MANAGEMENT OF COPD: 2023 Report, https://goldcopd.org/2023-gold-report-2/ (2023).
• Background Vestbo J, Lange P. Can GOLD Stage 0 provide information of prognostic value in chronic obstructive pulmonary disease? Am J Respir Crit Care Med. 2002 Aug 1;166(3):329-32. doi: 10.1164/rccm.2112048.
• Background GBD 2016 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1345-1422. doi: 10.1016/S0140-6736(17)32366-8.
• Background Anzueto A, Heijdra Y, Hurst RJ. Controversies ni COPD: ERS Monograph. European Respiratory Society, 2015.
• 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 Ramirez-Venegas A, Torres-Duque CA, Guzman-Bouilloud NE, Gonzalez-Garcia M, Sansores RH. SMALLa AIRWAY DISEASE IN COPD ASSOCIATED TO BIOMASS EXPOSURE. Rev Invest Clin. 2019;71(1):70-78. doi: 10.24875/RIC.18002652.
• Background Han MK, Agusti A, Celli BR, Criner GJ, Halpin DMG, Roche N, Papi A, Stockley RA, Wedzicha J, Vogelmeier CF. From GOLD 0 to Pre-COPD. Am J Respir Crit Care Med. 2021 Feb 15;203(4):414-423. doi: 10.1164/rccm.202008-3328PP. No abstract available.
• 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 Ramírez-Venagas A. Efficacy and Safety of ICS/LABA vs. LAMA/LABA in Patients With Different COPD Phenotypes. NCT05342558, https://classic.clinicaltrials.gov/ct2/show/NCT05342558 (2022).
• Background Han MK, Ye W, Wang D, White E, Arjomandi M, Barjaktarevic IZ, Brown SA, Buhr RG, Comellas AP, Cooper CB, Criner GJ, Dransfield MT, Drescher F, Folz RJ, Hansel NN, Kalhan R, Kaner RJ, Kanner RE, Krishnan JA, Lazarus SC, Maddipati V, Martinez FJ, Mathews A, Meldrum C, McEvoy C, Nyunoya T, Rogers L, Stringer WW, Wendt CH, Wise RA, Wisniewski SR, Sciurba FC, Woodruff PG; RETHINC Study Group. Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function. N Engl J Med. 2022 Sep 29;387(13):1173-1184. doi: 10.1056/NEJMoa2204752. Epub 2022 Sep 4.
• Background Borrill ZL, Houghton CM, Woodcock AA, Vestbo J, Singh D. Measuring bronchodilation in COPD clinical trials. Br J Clin Pharmacol. 2005 Apr;59(4):379-84. doi: 10.1111/j.1365-2125.2004.02261.x.
• Background Manoharan A, Morrison AE, Lipworth BJ. Effects of Adding Tiotropium or Aclidinium as Triple Therapy Using Impulse Oscillometry in COPD. Lung. 2016 Apr;194(2):259-66. doi: 10.1007/s00408-015-9839-y. Epub 2016 Jan 13.
• Background Sana A, Somda SMA, Meda N, Bouland C. Chronic obstructive pulmonary disease associated with biomass fuel use in women: a systematic review and meta-analysis. BMJ Open Respir Res. 2018 Jan 12;5(1):e000246. doi: 10.1136/bmjresp-2017-000246. eCollection 2018.
• Background Ramirez-Venegas A, Velazquez-Uncal M, Perez-Hernandez R, Guzman-Bouilloud NE, Falfan-Valencia R, Mayar-Maya ME, Aranda-Chavez A, Sansores RH. Prevalence of COPD and respiratory symptoms associated with biomass smoke exposure in a suburban area. Int J Chron Obstruct Pulmon Dis. 2018 May 25;13:1727-1734. doi: 10.2147/COPD.S156409. eCollection 2018.
• Background Orduz García CE, Toro MV, Gómez JC. EPOC, BRONQUITIS CRÓNICA YSÍNTOMAS RESPIRATORIOS, ASOCIADOS ALA CONTAMINACIÓN POR PM10 EN LA CIUDAD DE MEDELLÍN (COLOMBIA). Revista Med 2013; 21: 21-28.
• 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 Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
• Background Stanojevic S, Kaminsky DA, Miller MR, Thompson B, Aliverti A, Barjaktarevic I, Cooper BG, Culver B, Derom E, Hall GL, Hallstrand TS, Leuppi JD, MacIntyre N, McCormack M, Rosenfeld M, Swenson ER. ERS/ATS technical standard on interpretive strategies for routine lung function tests. Eur Respir J. 2022 Jul 13;60(1):2101499. doi: 10.1183/13993003.01499-2021. Print 2022 Jul.

Drugs

Indications