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

NCT03020212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2025-03-14

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Oxygen

The subjects will be randomly assigned to receive or not LTOT and they will be followed for 30 months. At baseline and then at 10, 20 and 30 months, they will be clinically evaluated with arterial blood gases, pulse oximetry, echocardiography, spirometry with bronchodilator, diffusion capacity, quality of life (SGRQ), neurocognitive performance (MMSE) and six minutes walk test. The primary outcome will evaluate the ratio of occurrence of erythrocytosis or pulmonary hypertension. Secondary outcomes will be evaluated quality of life, lung function, neurocognitive performance and exercise tolerance by comparing the groups with and without LTOT.

Sponsors & Collaborators

  • Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)

    collaborator OTHER_GOV

  • Fundación Neumologica Colombiana

    lead OTHER

Principal Investigators

  • Carlos A. Torres-Duque, MD · Fundación Neumológica Colombiana

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2025-01-31
Completion
2025-01-31

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03020212 on ClinicalTrials.gov