Long-term Oxygen Therapy in Patients With Chronic Obstructive Pulmonary Disease Who Live at High Altitude
NCT ID: NCT03020212
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
220 participants
INTERVENTIONAL
2016-02-29
2025-01-31
Brief Summary
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Detailed Description
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The subjects will be randomly assigned to receive or not LTOT and they will be followed for 20 to 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Oxygen
Long-term oxygen therapy in patients with chronic obstructive pulmonary disease (COPD)
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.
Not oxygen
No intervention ( no therapy with oxygen)
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
84 Years
ALL
No
Sponsors
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Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
OTHER_GOV
Fundación Neumologica Colombiana
OTHER
Responsible Party
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Principal Investigators
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Carlos A. Torres-Duque, MD
Role: PRINCIPAL_INVESTIGATOR
Fundación Neumológica Colombiana
Locations
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Fundación Neumológica Colombiana
Bogotá, , Colombia
Countries
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References
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Other Identifiers
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COLP
Identifier Type: -
Identifier Source: org_study_id
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