Long-term Oxygen Therapy in Patients With Chronic Obstructive Pulmonary Disease Who Live at High Altitude

Summary

A clinical, prospective, randomized controlled trial to determine the effect of prescribing oxygen in a group of COPD (chronic pulmonary disease) patients with PaO2 (arterial oxygen tension) ≥50 and ≤55 mmHg who do not have erythrocytosis or pulmonary hypertension on echocardiogram (which are considered manifestations of chronic hypoxia)

Timeline

Start

2016-02

Primary completion

2025-01

Completion

2025-01

Publications

• Background Kim V, Benditt JO, Wise RA, Sharafkhaneh A. Oxygen therapy in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2008 May 1;5(4):513-8. doi: 10.1513/pats.200708-124ET.
• Background Montes de Oca M, Lopez Varela MV, Acuna A, Schiavi E, Rey MA, Jardim J, Casas A, Tokumoto A, Torres Duque CA, Ramirez-Venegas A, Garcia G, Stirbulov R, Camelier A, Bergna M, Cohen M, Guzman S, Sanchez E. ALAT-2014 Chronic Obstructive Pulmonary Disease (COPD) Clinical Practice Guidelines: questions and answers. Arch Bronconeumol. 2015 Aug;51(8):403-16. doi: 10.1016/j.arbres.2014.11.017. Epub 2015 Jan 14. English, Spanish.
• Background Diaz-Lobato S, Mayoralas Alises S. [Should we reconsider the criteria for home oxygen therapy depending on altitude?]. Arch Bronconeumol. 2011 Aug;47(8):421-2. doi: 10.1016/j.arbres.2011.05.001. Epub 2011 Jul 6. No abstract available. Spanish.
• Background Semenza GL. HIF-1: mediator of physiological and pathophysiological responses to hypoxia. J Appl Physiol (1985). 2000 Apr;88(4):1474-80. doi: 10.1152/jappl.2000.88.4.1474.
• Background Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet. 2007 Sep 1;370(9589):765-73. doi: 10.1016/S0140-6736(07)61380-4.
• Background Pauwels RA, Rabe KF. Burden and clinical features of chronic obstructive pulmonary disease (COPD). Lancet. 2004 Aug 14-20;364(9434):613-20. doi: 10.1016/S0140-6736(04)16855-4.
• Background Hurd S. The impact of COPD on lung health worldwide: epidemiology and incidence. Chest. 2000 Feb;117(2 Suppl):1S-4S. doi: 10.1378/chest.117.2_suppl.1s.
• Background Murray CJ, Lopez AD. Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet. 1997 May 17;349(9063):1436-42. doi: 10.1016/S0140-6736(96)07495-8.
• Background Safe S, Hutzinger O, Ecobichon DJ, Grey AA. The metabolism of 4'chloro-4-biphenylol in the rat. Can J Biochem. 1975 Apr;53(4):415-20. doi: 10.1139/o75-057.
• Background Barbera JA, Peinado VI, Santos S. Pulmonary hypertension in chronic obstructive pulmonary disease. Eur Respir J. 2003 May;21(5):892-905. doi: 10.1183/09031936.03.00115402.
• Background Hu J, Discher DJ, Bishopric NH, Webster KA. Hypoxia regulates expression of the endothelin-1 gene through a proximal hypoxia-inducible factor-1 binding site on the antisense strand. Biochem Biophys Res Commun. 1998 Apr 28;245(3):894-9. doi: 10.1006/bbrc.1998.8543.
• Background Hochachka PW. Mechanism and evolution of hypoxia-tolerance in humans. J Exp Biol. 1998 Apr;201(Pt 8):1243-54. doi: 10.1242/jeb.201.8.1243.
• Background Juel C, Lundby C, Sander M, Calbet JA, Hall Gv. Human skeletal muscle and erythrocyte proteins involved in acid-base homeostasis: adaptations to chronic hypoxia. J Physiol. 2003 Apr 15;548(Pt 2):639-48. doi: 10.1113/jphysiol.2002.035899. Epub 2003 Feb 28.
• Background McClelland GB, Brooks GA. Changes in MCT 1, MCT 4, and LDH expression are tissue specific in rats after long-term hypobaric hypoxia. J Appl Physiol (1985). 2002 Apr;92(4):1573-84. doi: 10.1152/japplphysiol.01069.2001.
• Background McDonald CF, Blyth CM, Lazarus MD, Marschner I, Barter CE. Exertional oxygen of limited benefit in patients with chronic obstructive pulmonary disease and mild hypoxemia. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 1):1616-9. doi: 10.1164/ajrccm.152.5.7582304.
• Background Weitzenblum E, Chaouat A, Kessler R. Long-term oxygen therapy: do current guidelines need revision? Eur Respir J. 1999 May;13(5):1209-10. doi: 10.1034/j.1399-3003.1999.13e44.x. No abstract available.
• Background Hardinge M, Annandale J, Bourne S, Cooper B, Evans A, Freeman D, Green A, Hippolyte S, Knowles V, MacNee W, McDonnell L, Pye K, Suntharalingam J, Vora V, Wilkinson T; British Thoracic Society Home Oxygen Guideline Development Group; British Thoracic Society Standards of Care Committee. British Thoracic Society guidelines for home oxygen use in adults. Thorax. 2015 Jun;70 Suppl 1:i1-43. doi: 10.1136/thoraxjnl-2015-206865.
• Results Katsenos S, Constantopoulos SH. Long-Term Oxygen Therapy in COPD: Factors Affecting and Ways of Improving Patient Compliance. Pulm Med. 2011;2011:325362. doi: 10.1155/2011/325362. Epub 2011 Sep 15.
• Results Long term domiciliary oxygen therapy in chronic hypoxic cor pulmonale complicating chronic bronchitis and emphysema. Report of the Medical Research Council Working Party. Lancet. 1981 Mar 28;1(8222):681-6.
• Results Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.
• Results 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.
• Results Menezes AM, Perez-Padilla R, Jardim JR, Muino A, Lopez MV, Valdivia G, Montes de Oca M, Talamo C, Hallal PC, Victora CG; PLATINO Team. Chronic obstructive pulmonary disease in five Latin American cities (the PLATINO study): a prevalence study. Lancet. 2005 Nov 26;366(9500):1875-81. doi: 10.1016/S0140-6736(05)67632-5.
• Results Yu AY, Frid MG, Shimoda LA, Wiener CM, Stenmark K, Semenza GL. Temporal, spatial, and oxygen-regulated expression of hypoxia-inducible factor-1 in the lung. Am J Physiol. 1998 Oct;275(4):L818-26. doi: 10.1152/ajplung.1998.275.4.L818.
• Results Casanova C, Celli BR, Barria P, Casas A, Cote C, de Torres JP, Jardim J, Lopez MV, Marin JM, Montes de Oca M, Pinto-Plata V, Aguirre-Jaime A; Six Minute Walk Distance Project (ALAT). The 6-min walk distance in healthy subjects: reference standards from seven countries. Eur Respir J. 2011 Jan;37(1):150-6. doi: 10.1183/09031936.00194909. Epub 2010 Jun 4.
• Results Hurst JR, Vestbo J, Anzueto A, Locantore N, Mullerova H, Tal-Singer R, Miller B, Lomas DA, Agusti A, Macnee W, Calverley P, Rennard S, Wouters EF, Wedzicha JA; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Susceptibility to exacerbation in chronic obstructive pulmonary disease. N Engl J Med. 2010 Sep 16;363(12):1128-38. doi: 10.1056/NEJMoa0909883.
• Results Garina IA, Rakitskaya VV, Shalyapina VG. Receptor binding of corticosterone in monoaminergic structures of the brain of rats after neonatal blockade of the hypophyseoadrenal system. Neurosci Behav Physiol. 1991 Sep-Oct;21(5):387-90. doi: 10.1007/BF01200271. No abstract available.
• Results Casanova C, Cote C, Marin JM, Pinto-Plata V, de Torres JP, Aguirre-Jaime A, Vassaux C, Celli BR. Distance and oxygen desaturation during the 6-min walk test as predictors of long-term mortality in patients with COPD. Chest. 2008 Oct;134(4):746-752. doi: 10.1378/chest.08-0520. Epub 2008 Jul 14.
• Results Hiraga T, Maekura R, Okuda Y, Okamoto T, Hirotani A, Kitada S, Yoshimura K, Yokota S, Ito M, Ogura T. Prognostic predictors for survival in patients with COPD using cardiopulmonary exercise testing. Clin Physiol Funct Imaging. 2003 Nov;23(6):324-31. doi: 10.1046/j.1475-0961.2003.00514.x.
• Results Drummond MB, Blackford AL, Benditt JO, Make BJ, Sciurba FC, McCormack MC, Martinez FJ, Fessler HE, Fishman AP, Wise RA; NETT Investigators. Continuous oxygen use in nonhypoxemic emphysema patients identifies a high-risk subset of patients: retrospective analysis of the National Emphysema Treatment Trial. Chest. 2008 Sep;134(3):497-506. doi: 10.1378/chest.08-0117. Epub 2008 Jul 18.
• Results Stein DA, Bradley BL, Miller WC. Mechanisms of oxygen effects on exercise in patients with chronic obstructive pulmonary disease. Chest. 1982 Jan;81(1):6-10. doi: 10.1378/chest.81.1.6. No abstract available.
• Results Hardinge M, Suntharalingam J, Wilkinson T; British Thoracic Society. Guideline update: The British Thoracic Society Guidelines on home oxygen use in adults. Thorax. 2015 Jun;70(6):589-91. doi: 10.1136/thoraxjnl-2015-206918. Epub 2015 Apr 27.

Drugs

Indications