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

March 26, 2024 updated by: Fundación Neumologica Colombiana

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

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A clinical, prospective, randomized controlled trial to determine the effect of prescribing oxygen in a group of COPD patients with PaO2 ≥50 and ≤55 mmHg who do not have erythrocytosis or pulmonary hypertension on echocardiogram (which are considered manifestations of chronic hypoxia). It will be included 220 patients of the Fundación Neumológica Colombiana living in Bogotá who accept their participation by signing an informed consent.

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.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Bogotá, Colombia, 110131
        • Fundacion Neumologica Colombiana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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%
    • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxygen
Long-term oxygen therapy in patients with chronic obstructive pulmonary disease (COPD)
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.
Other Names:
  • LTOT
No Intervention: Not oxygen
No intervention ( no therapy with oxygen)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of pulmonary hypertension
Time Frame: 3 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of polycythemia
Time Frame: 3 years
A sample of hematocrit and hemoglobine will be perfomed to establish the presence of polycythemia at the begining of the study and every 10 months.
3 years
Evaluation of the pulmonary function
Time Frame: 3 years
Spirometry will be conducted to assess the Forced expiratory volume at 1 second and the Forced vital capacity at the begining of the study and every 10 months.
3 years
Number of exacerbations
Time Frame: 3 years
It will report the number of exacerbations that present the patients during the study
3 years
Evaluation of the quality of life
Time Frame: 3 years
It will perform the St. George Respiratory Questionnaire (SGRQ) to assess the quality of life of the patients at the begining of the study and every 10 months.
3 years
Assessment of neurocognitive function
Time Frame: 3 years
It will make a Mini mental Test to evaluate the neurocognitive performance at the begining of the study and every 10 months.
3 years
Evaluation of exercise tolerance
Time Frame: 3 years
It will conduct a six minute walk test to assess the exercise tolerance at the the begining of the study and every 10 months.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Neumologica Colombiana

Collaborators

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

Investigators

  • Principal Investigator: Carlos A. Torres-Duque, MD, Fundacion Neumologica Colombiana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

May 13, 2016

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimated)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COLP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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