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Chronic Obstructive Pulmonary DiseaseNCT03957759

Early Signs of Altitude Illness in Patients With COPD

An observational study of Chronic Obstructive Pulmonary Disease, run by University of Zurich at 1 site in Kyrgyzstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
Structured self-monitoring during an altitude ascent and stay at high altitude
How many people
153 participants
Where
1 siteKyrgyzstan
Study dates
20 May 2019to 8 Aug 2021
Phase
Observational
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with COPD, FEV1 40-80% predicted living at low altitude.

Who may be able to join

  • Male and female patients, age 18-75 yrs.
  • COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92%, PaCO2 <6 kPa at 760 m.
  • Born, raised and currently living at low altitude (<800 m).
  • Written informed consent.

Who cannot join

  • COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1 <40% predicted; oxygen saturation on room air <92% or hypercapnia at 760 m).
  • Other lung disease or disorder of control of breathing
  • Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day)

Trial locations and contacts

1 site in 1 country.

Kyrgyzstan1 site

  • National Center of Cardiology and Internal Medicine

    Bishkek

Other trials in Kyrgyzstan

About this study

Official title: Self-Monitoring for Early Signs of Altitude Illness in Patients With Chronic Obstructive Pulmonary Disease. A Diagnostic Test Accuracy Study.

This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel.

Read the detailed description

This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately identify whether or not they will experience an altitude-related illness during altitude travel. After baseline evaluation at 760 m, patients will travel by bus within 3-5 h to the Tuja Ashu high altitude clinic at 3'100 m and stay there for 2 days. During this period, participants will perform SSM. They are instructed to report to study personnel if they fulfill predefined criteria for impeding altitude-related illness.

A planned interim analysis will be performed after the first year of the study or after completion of study by 80 participants, whichever comes first to allow any necessary adaptations of the sample size or terminate the study early for futility or high accuracy of the index test.

Being tested
Structured self-monitoring during an altitude ascent and stay at high altitude
Keywords
Altitude, Hypobaric hypoxia, Altitude-related illness, Prevention
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Structured self-monitoring during an altitude ascent and stay at high altitudeDiagnostic test

    Structured self-monitoring by a symptom checklist in combination with a pulse oximeter worn at the wrist in lowlanders with COPD ascending from low altitude (760m) to high altitude (3100m).

Study groups in NCT03957759
Study groupRoleWhat they receive
COPD patientsNot described
Receives: Diagnostic Test: Structured self-monitoring during an altitude ascent and stay at high altitude

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnostic accurarcy measures of structured self-monitoring

    Diagnostic performance includes sensitivity, specificity, positive and negative predictive values, and receiver operator curve area under the the curve. The diagnostic performance will be compared statistically using c-statistics against the reference test. Reference test will be the occurence of altitude-related illness defined as the following:

    • AMS defined by the Lake Louise questionnaire score or with AMSc score
    • severe hypoxemia (SpO2 <80% at rest >30 min; or SpO2 <75% at rest >15 min;
    • intercurrent illness that cannot be relieved by simple measures such as paracetamol 3x500 mg/day, inhalation of bronchodilators.
    • dyspnea or discomfort at rest requiring treatment with oxygen
    • chest pain or ECG signs of cardiac ischemia
    • severe hypertension: systolic blood pressure >200 mmHg, diastolic blood pressure >110 mmHg
    • new onset neurologic impairment
    • Any condition that requires study withdrawal according to the decision of the independent physician

    Measured: Day 1 to 3 at 3100m

Secondary outcomes (6)

  1. Acute mountain sickness severity assessed by the Lake Louise score

    The severity of acute mountain sickness will be assessed by the Lake Louise questionnaire. The severity will be calculated when the presence of headache and at least one of the following symptoms is present: gastrointestinal upset, fatigue or weakness and dizziness or lightheadedness. Each of the four questions is asked with the corresponding 0 to 3 rating of the response (0 = Not present, 1 = mild, 2 = moderate, 3 = severe). The sum of the responses on these questions is then calculated, resulting in the AMS severity.

    Measured: Day 1 to 3 at 3100m

  2. Altitude-related illness, incidence

    Incidence of ARI during the stay at 3100 m.

    ARI is defined as the following:

    • AMS defined by the Lake Louise questionnaire score or with AMSc score
    • severe hypoxemia (SpO2 <80% at rest >30 min; or SpO2 <75% at rest >15 min;
    • intercurrent illness that cannot be relieved by simple measures such as paracetamol 3x500 mg/day, inhalation of bronchodilators.
    • dyspnea or discomfort at rest requiring treatment with oxygen
    • chest pain or ECG signs of cardiac ischemia
    • severe hypertension: systolic blood pressure >200 mmHg, diastolic blood pressure >110 mmHg
    • new onset neurologic impairment
    • Any condition that requires study withdrawal according to the decision of the independent physician

    Measured: Day 1 to 3 at 3100m

  3. Spirometric measurement of forced expiratory volume in one second

    Altitude-induced change in the forced expiratory volume in one between 760 and 3100m

    Measured: Day 2 at 760 and 3100m

  4. Arterial partial pressure of oxygen

    Altitude-induced change in arterial partial pressure of oxygen assessed by arterial blood gas puncture at 760 and 3100m

    Measured: Day 2 at 760 and 3100m

  5. Six-minute walk distance in meters

    Altitude-induced change in the six-minute walk distance assessed by the six-minute walk test performed at 760 and 3100m

    Measured: Day 2 at 760 and 3100m

  6. Changes in ST-Segment of the ECG during ergometry

    Altitude-induced change in the ST-Segment of the ECG assessed during a maximal ergometry test performed at 760 and 3100m

    Measured: Day 1 at 760 and 3100m

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2019
  2. Study start20 May 2019
  3. Primary completion8 Aug 2021
  4. Study completion8 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03957759
Sponsor's protocol ID
01-8/464-14
Status last verified
Nov 2022
First submitted
16 May 2019
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Furian M, Reiser AE, Mademilov M, Sutter S, Champigneulle B, Grimm M, Magdieva K, Beishenaliev AS, Sooronbaev TM, Ulrich S, Bloch KE. Self-monitoring symptoms and pulse oximetry to predict imminent altitude illness in patients with chronic obstructive pulmonary disease. Pulmonology. 2026 Dec;32(1):2588515. doi: 10.1080/25310429.2025.2588515. Epub 2025 Dec 23.

    PubMed 41433778

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Obstructive Pulmonary Disease, run by University of Zurich at 1 site in Kyrgyzstan.

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 4 inclusion and 3 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 29 Nov 2022. 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 Kyrgyzstan. 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?

Diagnostic accurarcy measures of structured self-monitoring (time frame: Day 1 to 3 at 3100m). 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 NCT03957759, which also lists 1 linked publication.

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 29 Nov 2022.

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