Long-term Oxygen Therapy in Patients With Chronic Obstructive Pulmonary Disease Who Live at High … (NCT03020212) | Clinical Trial Compass
CompletedNot Applicable
Long-term Oxygen Therapy in Patients With Chronic Obstructive Pulmonary Disease Who Live at High Altitude
Colombia220 participantsStarted 2016-02
Plain-language 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)
Who can participate
Age range
40 Years – 84 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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%…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.