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

This is an interventional other trial for COPD focused on measuring Chronic obstructive pulmonary disease, High altitude, Oxygen, long-term oxygen therapy, pulmonary hypertension, chronic hypoxemia Read More

Inclusion Criteria:

• Men and women between ≥ 40 years and < 85 years living in Bogotá or in a high - altitude city (>2.500 - <3.500 m).
• Diagnosis of COPD defined by FEV1 / FVC <LLN (Lower limit of normal value) and significant exposure to cigarette ≥ 10 packs / year or woodsmoke ≥ 10 years.
• Diagnosis of ACO defined by FEV1 / FVC post BD <70%, significant exposure to cigarette or woodsmoke and asthma diagnosed before 40 years and/or wheezing, cough with spirometry with a high respond to bronchodilator (FEV1 or FVC ≥ 15% and 400 ml) or eosinophil >300 cels.
• PaO2 ≥ 50 and ≤ 55 mmHg or oxygen desaturation during the six-minute walk test (at least in three of the measurements performed during the exam) or during sleep (SpO2 ≤ 85% in ≥ 30% of the total time of sleep)
• No clinical signs of cor pulmonale
• Clinically stable COPD defined as no exacerbations in the last three months.
• Signature of informed consent.

Exclusion Criteria:

• BMI ≥40.

• Paraclinical findings of chronic hypoxemia and pulmonary hypertension:

  • Hematocrit ≥ 55%.
  • Pulmonary hypertension (PH) defined by transthoracic echocardiography systolic pulmonary artery pressure > 40 mmHg or indirect signs of PH: Pulmonary artery acceleration time <100ms associated with a meso-systolic notch and flattening of the septum interventricular in systole.

• Echocardiographic findings that could lead to pulmonary hypertension.

  • Left ventricular systolic dysfunction defined by an ejection fraction <40%
  • Left ventricular diastolic dysfunction higher than grade I.
  • Valvular disease higher than moderate
• Use of oxygen > 12 hours a day for more than six months in the last year.
• Comorbidities not controlled or deemed medically that can contribute to mortality during the study follow-up.
• Diagnosis of severe sleep apnea-hypopnea syndrome without treatment
• Plan of transfer of residence below 2.500 meters.
• Medical, psychiatric, social and administrative conditions that define high probability of poor adherence to therapy with oxygen.
• Active smoking