Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT03156231
Effect Of Acetazolamide On Altitude Related Illness In Patients With Respiratory Disease
A Phase 4 study testing ACETAZOLAMIDE oral capsule in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Zurich at 1 site in Kyrgyzstan.
Trial summary
Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive lung disease travelling from 760 m to 3200 m. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- ACETAZOLAMIDE oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 185 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 24 May 2017to 2 Aug 2018
- Phase
- Phase 4
- 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
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% at 750 m.
- Born, raised and currently living at low altitude (<800m).
- Written informed consent.
Who cannot join
- COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC <0.7, FEV1 <40% predicted, oxygen saturation on room air <92% at 750 m).
- Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
- Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (>20 cigarettes per day)
- Known renal failure or allergy to acetazolamide and other sulfonamides
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site
National Center of Cardiology and Internal Medicine
Bishkek, 720040
About this study
Official title: Acetazolamide for Prevention of Altitude Related Illness in Patients With Chronic Obstructive Pulmonary Disease (COPD). Randomized, Placebo-Controlled, Double-Blind Trial.
Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive lung disease travelling from 760 m to 3200 m.
Read the detailed description
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis in reducing the incidence of altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.
An interim analysis will be carried out when 90 patients will have completed the study or after the first year. The Peto's method will be used to correct the P-values.
- Being tested
- ACETAZOLAMIDE oral capsule, Placebo oral capsule
- Keywords
- airway disease, bronchitis, emphysema, altitude, prevention, acetazolamide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACETAZOLAMIDE oral capsuleDrug
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
Placebo oral capsuleDrug
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
| Study group | Role | What they receive |
|---|---|---|
| ACETAZOLAMIDE oral capsule | Active comparator | Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m Receives: Drug: ACETAZOLAMIDE oral capsule |
| PLACEBO oral capsule | Placebo comparator | Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Altitude related adverse health effects (ARAHE), cumulative incidence
Difference between acetazolamide and placebo group in cumulative incidence of ARAHE during the stay at 3200 m.
ARAHE are defined as the following:
- Moderate to severe AMS (Lake Louise score ≥3 and/or Environmental Symptoms questionnaire AMSc score ≥0.7) and/or any of the following:
- Severe hypoxemia (SpO2 at rest <80% for >30 min or <75% for >15 min, exercise oxygen desaturation SpO2 <75% for >1 min accompanied by symptoms or signs of hypoxemia)
- Symptomatic cardiovascular disease (arterial blood pressure systolic >200 mmHg, diastolic >110 mmHg not responding to blood pressure lowering drugs within 1 hr; chest pain with ECG signs of ischemia or new onset arrhythmia)
- Withdrawal from the study by the decision of the independent physician for safetey reasons or by the patient
Measured: Day 1 to 3 at 3200m
Secondary outcomes (7)
Acute mountain sickness, severity
Difference between acetazolamide and placebo group in the acute mountain sickness severity assessed by the Lake Louise questionnaire.
Measured: Day 1 to 3 at 3200m
6 min walk distance
Difference in altitude-induced change in the distance walked in 6 min between the acetazolamide and placebo group.
Measured: Day 2 at 760m and 3200m
Perceived exertion
Difference in altitude-induced change in the perceived exertion rated with the Borg CR10 scale between the acetazolamide and placebo group
Measured: Day 2 at 760m and 3200m
Spirometry
Difference in altitude-induced change in the spirometric variables between the acetazolamide and placebo group
Measured: Day 2 at 760m and 3200m
Arterial blood gases
Difference in altitude-induced change in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the acetazolamide and placebo group
Measured: Day 2 at 760m and 3200m
Exercise endurance during constant load cycling ergometry
Difference in altitude-induced change in exercise endurance between acetazolamide and placebo group, measured by constant load cycling ergometry
Measured: Day 3 at 760m and 3200m
Side effects
Difference between acetazolamide and placebo group in the cumulative incidence of medication side effects during the stay at 3200 m.
Measured: Day 1 to 3 at 3200m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start24 May 2017
- Primary completion2 Aug 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Responsible party
- Sponsor
- Investigators
- Konrad E Bloch, MD, Study chair, University Hospital, ZürichTalant M Sooronbaev, MD, Study director, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156231
- Sponsor's protocol ID
- 2017-00137
- Other IDs
- 2017
- Status last verified
- Jun 2017
- First submitted
- 15 May 2017
- Last updated
- 29 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schmuziger YA, Mademilov M, Buergin A, Scheiwiller PM, Mayer L, Schneider SR, Lichtblau M, Bitos K, Muralt L, Muller J, Akylbekov A, Mirzalieva G, Sooronbaev TM, Ulrich S, Bloch KE, Furian M. Nocturnal cerebral oxygenation in patients with COPD at altitude: data from a randomized clinical trial of acetazolamide. J Clin Sleep Med. 2025 Dec 1;21(12):2051-2061. doi: 10.5664/jcsm.11868.
PubMed 41025408Christen M, Buergin A, Mademilov M, Mayer L, Schneider SR, Lichtblau M, Sooronbaev TM, Ulrich S, Bloch KE, Furian M. Electrocardiographic signs of cardiac ischemia at rest and during exercise in patients with COPD traveling to 3,100 m: data from a randomized trial of acetazolamide. Front Cardiovasc Med. 2025 Feb 6;12:1524201. doi: 10.3389/fcvm.2025.1524201. eCollection 2025.
PubMed 39981351Furian M, Mademilov M, Buergin A, Scheiwiller PM, Mayer L, Schneider S, Emilov B, Lichtblau M, Bitos K, Muralt L, Groth A, Reiser AE, Sevik A, Sheraliev U, Marazhapov NH, Aydaralieva S, Muratbekova A, Tabyshova A, Abdraeva A, Buenzli S, Sooronbaev TM, Ulrich S, Bloch KE. Acetazolamide to Prevent Adverse Altitude Effects in COPD and Healthy Adults. NEJM Evid. 2022 Jan;1(1):EVIDoa2100006. doi: 10.1056/EVIDoa2100006. Epub 2021 Dec 22.
PubMed 38296630
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetazolamide for Prevention of Altitude Related Illness in Patients With Chronic Obstructive Pulmonary Disease (COPD). Randomized, Placebo-Controlled, Double-Blind Trial.
- ClinicalTrials.gov ID
- NCT03156231
- Acronym / sponsor ID
- 2017-00137
- Keywords
- airway disease, bronchitis, emphysema, altitude, prevention, acetazolamide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Study start
- 24 May 2017 (actual)
- Primary completion
- 2 Aug 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 17 May 2017 (actual)
- 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.
Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive lung disease travelling from 760 m to 3200 m.
Detailed description
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis in reducing the incidence of altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.
An interim analysis will be carried out when 90 patients will have completed the study or after the first year. The Peto's method will be used to correct the P-values.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACETAZOLAMIDE oral capsule | Active comparator | Drug: ACETAZOLAMIDE oral capsuleAcetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m |
| PLACEBO oral capsule | Placebo comparator | Drug: Placebo oral capsulePlacebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients, age 18-75 yrs.
- COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
- Born, raised and currently living at low altitude (<800m).
- Written informed consent.
Key exclusion criteria (4 listed)
- COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC <0.7, FEV1 <40% predicted, oxygen saturation on room air <92% at 750 m).
- Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
- Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (>20 cigarettes per day)
- Known renal failure or allergy to acetazolamide and other sulfonamides
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 |
|---|---|---|
| ACETAZOLAMIDE oral capsuleAdministration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m | Drug | ACETAZOLAMIDE oral capsule |
| Placebo oral capsuleAdministration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m | Drug | PLACEBO oral capsule |
Primary outcome
Altitude related adverse health effects (ARAHE), cumulative incidence
Time frame: Day 1 to 3 at 3200m
Difference between acetazolamide and placebo group in cumulative incidence of ARAHE during the stay at 3200 m. ARAHE are defined as the following: * Moderate to severe AMS (Lake Louise score ≥3 and/or Environmental Symptoms questionnaire AMSc score ≥0.7) and/or any of the following: * Severe hypoxemia (SpO2 at rest <80% for >30 min or <75% for >15 min, exercise oxygen desaturation SpO2 <75% for >1 min accompanied by symptoms or signs of hypoxemia) * Symptomatic cardiovascular disease (arterial blood pressure systolic >200 mmHg, diastolic >110 mmHg not responding to blood pressure lowering drugs within 1 hr; chest pain with ECG signs of ischemia or new onset arrhythmia) * Withdrawal from the study by the decision of the independent physician for safetey reasons or by the patient
7 secondary outcomes
Acute mountain sickness, severity
Time frame: Day 1 to 3 at 3200m
6 min walk distance
Time frame: Day 2 at 760m and 3200m
Perceived exertion
Time frame: Day 2 at 760m and 3200m
Spirometry
Time frame: Day 2 at 760m and 3200m
Arterial blood gases
Time frame: Day 2 at 760m and 3200m
Exercise endurance during constant load cycling ergometry
Time frame: Day 3 at 760m and 3200m
Side effects
Time frame: Day 1 to 3 at 3200m
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 29 Jan 2019.
- Derived from this study: PubMed 41025408Schmuziger YA, Mademilov M, Buergin A, Scheiwiller PM, Mayer L, Schneider SR, Lichtblau M, Bitos K, Muralt L, Muller J, Akylbekov A, Mirzalieva G, Sooronbaev TM, Ulrich S, Bloch KE, Furian M. Nocturnal cerebral oxygenation in patients with COPD at altitude: data from a randomized clinical trial of acetazolamide. J Clin Sleep Med. 2025 Dec 1;21(12):2051-2061. doi: 10.5664/jcsm.11868.
- Derived from this study: PubMed 39981351Christen M, Buergin A, Mademilov M, Mayer L, Schneider SR, Lichtblau M, Sooronbaev TM, Ulrich S, Bloch KE, Furian M. Electrocardiographic signs of cardiac ischemia at rest and during exercise in patients with COPD traveling to 3,100 m: data from a randomized trial of acetazolamide. Front Cardiovasc Med. 2025 Feb 6;12:1524201. doi: 10.3389/fcvm.2025.1524201. eCollection 2025.
- Derived from this study: PubMed 38296630Furian M, Mademilov M, Buergin A, Scheiwiller PM, Mayer L, Schneider S, Emilov B, Lichtblau M, Bitos K, Muralt L, Groth A, Reiser AE, Sevik A, Sheraliev U, Marazhapov NH, Aydaralieva S, Muratbekova A, Tabyshova A, Abdraeva A, Buenzli S, Sooronbaev TM, Ulrich S, Bloch KE. Acetazolamide to Prevent Adverse Altitude Effects in COPD and Healthy Adults. NEJM Evid. 2022 Jan;1(1):EVIDoa2100006. doi: 10.1056/EVIDoa2100006. Epub 2021 Dec 22.
- Individual participant dataSharing planned: Undecided
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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.
Konrad E Bloch, MD study chair
University Hospital, Zürich
Talant M Sooronbaev, MD study director
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACETAZOLAMIDE oral capsule in people with Chronic Obstructive Pulmonary Disease (COPD), 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 4 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 Jan 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Altitude related adverse health effects (ARAHE), cumulative incidence (time frame: Day 1 to 3 at 3200m). 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 NCT03156231, which also lists 3 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 29 Jan 2019.