COPDCOPD-LTOTNCT03020212
Long-term Oxygen Therapy in Patients With Chronic Obstructive Pulmonary Disease Who Live at High Altitude
A study testing Oxygen in people with COPD, run by Fundación Neumologica Colombiana at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 84 years
- Conditions the study is for
- COPD
- What is being tested?
- Oxygen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteColombia
- Study dates
- Feb 2016to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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.
- Conditions
- COPD
- Being tested
- Oxygen
- Keywords
- Chronic obstructive pulmonary disease, High altitude, Oxygen, long-term oxygen therapy, pulmonary hypertension, chronic hypoxemia
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Altitude Sickness, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Also called LTOT
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | Active comparator | Long-term oxygen therapy in patients with chronic obstructive pulmonary disease (COPD) Receives: Drug: Oxygen |
| Not oxygen | No intervention | No intervention ( no therapy with oxygen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (6)
Development of polycythemia
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.
Measured: 3 years
Evaluation of the pulmonary function
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.
Measured: 3 years
Number of exacerbations
It will report the number of exacerbations that present the patients during the study
Measured: 3 years
Evaluation of the quality of life
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.
Measured: 3 years
Assessment of neurocognitive function
It will make a Mini mental Test to evaluate the neurocognitive performance at the begining of the study and every 10 months.
Measured: 3 years
Evaluation of exercise tolerance
It will conduct a six minute walk test to assess the exercise tolerance at the the begining of the study and every 10 months.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2017 (estimated)
- Study startFeb 2016
- Primary completionJan 2025
- Study completionJan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Neumologica Colombiana
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Responsible party
- Sponsor
- Investigators
- Carlos A. Torres-Duque, MD, Principal investigator, Fundación Neumológica Colombiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03020212
- Sponsor's protocol ID
- COLP
- Acronym
- COPD-LTOT
- Status last verified
- Mar 2025
- First submitted
- 13 May 2016
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim V, Benditt JO, Wise RA, Sharafkhaneh A. Oxygen therapy in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2008 May 1;5(4):513-8. doi: 10.1513/pats.200708-124ET.
PubMed 18453364Montes de Oca M, Lopez Varela MV, Acuna A, Schiavi E, Rey MA, Jardim J, Casas A, Tokumoto A, Torres Duque CA, Ramirez-Venegas A, Garcia G, Stirbulov R, Camelier A, Bergna M, Cohen M, Guzman S, Sanchez E. ALAT-2014 Chronic Obstructive Pulmonary Disease (COPD) Clinical Practice Guidelines: questions and answers. Arch Bronconeumol. 2015 Aug;51(8):403-16. doi: 10.1016/j.arbres.2014.11.017. Epub 2015 Jan 14. English, Spanish.
PubMed 25596991Diaz-Lobato S, Mayoralas Alises S. [Should we reconsider the criteria for home oxygen therapy depending on altitude?]. Arch Bronconeumol. 2011 Aug;47(8):421-2. doi: 10.1016/j.arbres.2011.05.001. Epub 2011 Jul 6. No abstract available. Spanish.
PubMed 21737196Semenza GL. HIF-1: mediator of physiological and pathophysiological responses to hypoxia. J Appl Physiol (1985). 2000 Apr;88(4):1474-80. doi: 10.1152/jappl.2000.88.4.1474.
PubMed 10749844Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet. 2007 Sep 1;370(9589):765-73. doi: 10.1016/S0140-6736(07)61380-4.
PubMed 17765526Pauwels RA, Rabe KF. Burden and clinical features of chronic obstructive pulmonary disease (COPD). Lancet. 2004 Aug 14-20;364(9434):613-20. doi: 10.1016/S0140-6736(04)16855-4.
PubMed 15313363Hurd S. The impact of COPD on lung health worldwide: epidemiology and incidence. Chest. 2000 Feb;117(2 Suppl):1S-4S. doi: 10.1378/chest.117.2_suppl.1s.
PubMed 10673465Murray CJ, Lopez AD. Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet. 1997 May 17;349(9063):1436-42. doi: 10.1016/S0140-6736(96)07495-8.
PubMed 9164317Safe S, Hutzinger O, Ecobichon DJ, Grey AA. The metabolism of 4'chloro-4-biphenylol in the rat. Can J Biochem. 1975 Apr;53(4):415-20. doi: 10.1139/o75-057.
PubMed 1125825Barbera JA, Peinado VI, Santos S. Pulmonary hypertension in chronic obstructive pulmonary disease. Eur Respir J. 2003 May;21(5):892-905. doi: 10.1183/09031936.03.00115402.
PubMed 12765440Hu J, Discher DJ, Bishopric NH, Webster KA. Hypoxia regulates expression of the endothelin-1 gene through a proximal hypoxia-inducible factor-1 binding site on the antisense strand. Biochem Biophys Res Commun. 1998 Apr 28;245(3):894-9. doi: 10.1006/bbrc.1998.8543.
PubMed 9588211Hochachka PW. Mechanism and evolution of hypoxia-tolerance in humans. J Exp Biol. 1998 Apr;201(Pt 8):1243-54. doi: 10.1242/jeb.201.8.1243.
PubMed 9510535Juel C, Lundby C, Sander M, Calbet JA, Hall Gv. Human skeletal muscle and erythrocyte proteins involved in acid-base homeostasis: adaptations to chronic hypoxia. J Physiol. 2003 Apr 15;548(Pt 2):639-48. doi: 10.1113/jphysiol.2002.035899. Epub 2003 Feb 28.
PubMed 12611920McClelland GB, Brooks GA. Changes in MCT 1, MCT 4, and LDH expression are tissue specific in rats after long-term hypobaric hypoxia. J Appl Physiol (1985). 2002 Apr;92(4):1573-84. doi: 10.1152/japplphysiol.01069.2001.
PubMed 11896024McDonald CF, Blyth CM, Lazarus MD, Marschner I, Barter CE. Exertional oxygen of limited benefit in patients with chronic obstructive pulmonary disease and mild hypoxemia. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 1):1616-9. doi: 10.1164/ajrccm.152.5.7582304.
PubMed 7582304
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03020212
- Acronym / sponsor ID
- COPD-LTOT / COLP
- Conditions
- COPD
- Keywords
- Chronic obstructive pulmonary disease, High altitude, Oxygen, long-term oxygen therapy, pulmonary hypertension, chronic hypoxemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Fundación Neumologica ColombianaUniversity, hospital or other
- Collaborators
- Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
- Study start
- Feb 2016
- Primary completion
- Jan 2025 (actual)
- Study completion
- Jan 2025 (actual)
- First posted
- 13 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen | Active comparator | Drug: OxygenLong-term oxygen therapy in patients with chronic obstructive pulmonary disease (COPD) |
| Not oxygen | No intervention | –No intervention ( no therapy with oxygen) |
Who may qualify
- Ages
- 40 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- BMI ≥40.
- Paraclinical findings of chronic hypoxemia and pulmonary hypertension:
- Echocardiographic findings that could lead to pulmonary hypertension.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenAlso: LTOTThe 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. | Drug | Oxygen |
Primary outcome
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
6 secondary outcomes
Development of polycythemia
Time frame: 3 years
Evaluation of the pulmonary function
Time frame: 3 years
Number of exacerbations
Time frame: 3 years
Evaluation of the quality of life
Time frame: 3 years
Assessment of neurocognitive function
Time frame: 3 years
Evaluation of exercise tolerance
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Background: PubMed 18453364Kim V, Benditt JO, Wise RA, Sharafkhaneh A. Oxygen therapy in chronic obstructive pulmonary disease. Proc Am Thorac Soc. 2008 May 1;5(4):513-8. doi: 10.1513/pats.200708-124ET.
- Background: PubMed 25596991Montes de Oca M, Lopez Varela MV, Acuna A, Schiavi E, Rey MA, Jardim J, Casas A, Tokumoto A, Torres Duque CA, Ramirez-Venegas A, Garcia G, Stirbulov R, Camelier A, Bergna M, Cohen M, Guzman S, Sanchez E. ALAT-2014 Chronic Obstructive Pulmonary Disease (COPD) Clinical Practice Guidelines: questions and answers. Arch Bronconeumol. 2015 Aug;51(8):403-16. doi: 10.1016/j.arbres.2014.11.017. Epub 2015 Jan 14. English, Spanish.
- Background: PubMed 21737196Diaz-Lobato S, Mayoralas Alises S. [Should we reconsider the criteria for home oxygen therapy depending on altitude?]. Arch Bronconeumol. 2011 Aug;47(8):421-2. doi: 10.1016/j.arbres.2011.05.001. Epub 2011 Jul 6. No abstract available. Spanish.
- Background: PubMed 10749844Semenza GL. HIF-1: mediator of physiological and pathophysiological responses to hypoxia. J Appl Physiol (1985). 2000 Apr;88(4):1474-80. doi: 10.1152/jappl.2000.88.4.1474.
- Background: PubMed 17765526Mannino DM, Buist AS. Global burden of COPD: risk factors, prevalence, and future trends. Lancet. 2007 Sep 1;370(9589):765-73. doi: 10.1016/S0140-6736(07)61380-4.
- Background: PubMed 15313363Pauwels RA, Rabe KF. Burden and clinical features of chronic obstructive pulmonary disease (COPD). Lancet. 2004 Aug 14-20;364(9434):613-20. doi: 10.1016/S0140-6736(04)16855-4.
- Background: PubMed 10673465Hurd S. The impact of COPD on lung health worldwide: epidemiology and incidence. Chest. 2000 Feb;117(2 Suppl):1S-4S. doi: 10.1378/chest.117.2_suppl.1s.
- Background: PubMed 9164317Murray CJ, Lopez AD. Global mortality, disability, and the contribution of risk factors: Global Burden of Disease Study. Lancet. 1997 May 17;349(9063):1436-42. doi: 10.1016/S0140-6736(96)07495-8.
- Background: PubMed 1125825Safe S, Hutzinger O, Ecobichon DJ, Grey AA. The metabolism of 4'chloro-4-biphenylol in the rat. Can J Biochem. 1975 Apr;53(4):415-20. doi: 10.1139/o75-057.
- Background: PubMed 12765440Barbera JA, Peinado VI, Santos S. Pulmonary hypertension in chronic obstructive pulmonary disease. Eur Respir J. 2003 May;21(5):892-905. doi: 10.1183/09031936.03.00115402.
- Background: PubMed 9588211Hu J, Discher DJ, Bishopric NH, Webster KA. Hypoxia regulates expression of the endothelin-1 gene through a proximal hypoxia-inducible factor-1 binding site on the antisense strand. Biochem Biophys Res Commun. 1998 Apr 28;245(3):894-9. doi: 10.1006/bbrc.1998.8543.
- Background: PubMed 9510535Hochachka PW. Mechanism and evolution of hypoxia-tolerance in humans. J Exp Biol. 1998 Apr;201(Pt 8):1243-54. doi: 10.1242/jeb.201.8.1243.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A. Torres-Duque, MD principal investigator
Fundación Neumológica Colombiana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen in people with COPD, run by Fundación Neumologica Colombiana at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of pulmonary hypertension (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03020212, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.