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

NCT03020212 | Completed

• 1 other identifier: COLP
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

COPD

Keywords

Chronic obstructive pulmonary disease; High altitude; Oxygen; long-term oxygen therapy; pulmonary hypertension; chronic hypoxemia

Outcome Measures

Primary Outcomes (1)

• Development of pulmonary hypertension

  An echocardiogram will be conducted every ten months to measure the value of pulmonary artery pressure and establish the presence of pulmonary hypertension

  3 years

Secondary Outcomes (6)

• Development of polycythemia

  3 years

• Evaluation of the pulmonary function

  3 years

• Number of exacerbations

  3 years

• Evaluation of the quality of life

  3 years

• Assessment of neurocognitive function

  3 years

Study Arms (2)

Oxygen

ACTIVE COMPARATOR

Long-term oxygen therapy in patients with chronic obstructive pulmonary disease (COPD)

Drug: Oxygen

Not oxygen

NO INTERVENTION

No intervention ( no therapy with oxygen)

Interventions

Oxygen DRUG

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.

Also known as: LTOT

Oxygen

Eligibility Criteria

• Age: 40 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Neumologica Colombiana: lead
• Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS): collaborator

Study Sites (1)

Fundación Neumológica Colombiana

Bogotá, 110131, Colombia

Location

Related Publications (31)

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MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Altitude Sickness; Hypertension, Pulmonary

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Carlos A. Torres-Duque, MD

  Fundación Neumológica Colombiana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2016
• First Posted: January 13, 2017
• Study Start: February 1, 2016
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)