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

Sponsor

Fundación Neumologica Colombiana (Other)

Overall Status

Recruiting

CT.gov ID

NCT03020212

Collaborator

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

220

Enrollment

Location

Arms

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
COPD	Drug: Oxygen	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Study Start Date :

Feb 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Development of pulmonary hypertension [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

Secondary Outcome Measures

Development of polycythemia [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.
Evaluation of the pulmonary function [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.
Number of exacerbations [3 years]
It will report the number of exacerbations that present the patients during the study
Evaluation of the quality of life [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.
Assessment of neurocognitive function [3 years]
It will make a Mini mental Test to evaluate the neurocognitive performance at the begining of the study and every 10 months.
Evaluation of exercise tolerance [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 84 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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