NCT03020212Completed
Long-term Oxygen Therapy in Patients With Chronic Obstructive Pulmonary Disease Who Live at High Altitude
Long-term Oxygen Therapy in Patients With Chronic Obstructive Pulmonary Disease (COPD) Who Live at High Altitude (2640 Meters Above Sea Level): Evaluation of a Proposal for Adjusting Criteria
Source: ClinicalTrials.gov · Last updated 14 Mar 2025
Brief summary (registry, in English)
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)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 220 (actual)
- First submitted
- 13 May 2016
- Start date
- 1 Feb 2016
- Primary completion date
- 31 Jan 2025
- Lead sponsor
- Fundación Neumologica Colombiana
- NCT number
- NCT03020212
What you commit to
- Study type: Interventional
- Participants enrolled: 220
- From 1 Feb 2016 to the primary completion date, 31 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- Diagnosis of severe sleep apnea-hypopnea syndrome without treatment
- Medical, psychiatric, social and administrative conditions that define high probability of poor adherence to therapy with oxygen.
Lab values
- 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
Other
- BMI ≥40.
- 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.
- Plan of transfer of residence below 2.500 meters.
- Active smoking
Who the study is looking for
- 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.
Age in the registry: 40 years to 84 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fundacion Neumologica Colombiana Coordinator of this site? Confirm its status | Bogotá | Colombia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.