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

• Status: Recruiting
• Trial end date: 2022-01-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Neumologica Colombiana
• Collaborator: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

Criteria

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 / FVCsignificant 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