Chronic Obstructive Pulmonary DiseasePhase 3NCT04913389
Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD
A Phase 3 study testing Acetazolamide in people with Chronic Obstructive Pulmonary Disease and Altitude Sickness, run by University of Zurich at 1 site in Kyrgyzstan.
Trial summary
The purpose of this randomized, placebo-controlled double-blind trial is to evaluate efficacy of acetazolamide in preventing overt altitude-related adverse health effects (ARAHE) in lowlanders with chronic obstructive pulmonary disease (COPD) developing early signs of altitude-illness during altitude travel. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Altitude Sickness, Altitude Hypoxia
- What is being tested?
- Acetazolamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 1 Jun 2021to 31 Dec 2023
- Phase
- Phase 3
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, age 35-75 y, living at low altitude (<800 m).
- COPD diagnosed according to the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, forced expiratory volume in one second 40-80% predicted, pulse oximetry ≥92%, PaCO2 <6 kilopascal, breathing ambient air at 760 m.
- One of the following early signs and/or symptoms of impending altitude-illness identified by self-monitoring during ascent to or stay at 3100 m:
- Pulse oximetry SpO2≤84%
- Headache or nausea/vomiting or fatigue/weakness or dizziness/light-headedness of at least moderate intensity
Who cannot join
- COPD exacerbation, very severe COPD with hypoxemia or hypercapnia at 760 m (see above).
- Other lung disease, relevant comorbidities (such as uncontrolled cardiovascular disease, i.e., unstable arterial hypertension, coronary artery disease; previous stroke; obesity (body mass index >35 kg/m2); internal, neurologic, rheumatologic or psychiatric disease; current heavy smoking (>20 cigarettes per day).
- Renal failure and/or allergy to sulfonamides.
- Patients who do not have early signs and/or signs of impending altitude-illness by self-monitoring (as defined above) at 3'100m will not be included.
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: Novel Approach to Prevention of Altitude-related Illness in Patients With Chronic Obstructive Pulmonary Disease
The purpose of this randomized, placebo-controlled double-blind trial is to evaluate efficacy of acetazolamide in preventing overt altitude-related adverse health effects (ARAHE) in lowlanders with chronic obstructive pulmonary disease (COPD) developing early signs of altitude-illness during altitude travel.
Read the detailed description
This randomized placebo-controlled, double-blind, parallel-design trial will evaluate effectiveness of acetazolamide in reducing the incidence of predefined altitude-related adverse health effects in lowlanders with chronic obstructive pulmonary disease (COPD) travelling to high altitude and developping early symptoms and/or signs of impending altitude-illness. Qualifying participants will be randomized 1:1 to acetazolamide or placebo treatment during their further stay of 2 days at 3'100 m.
An interim-analysis will be performed after the first year of the study or when 38 participants are randomized, whichever comes first. Symmetric stopping boundaries at P<0.001 will be applied (Peto approach).
- Being tested
- Acetazolamide, Placebo
- Keywords
- Acetazolamide, Mountain sickness, Hypoxemia, Prevention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Altitude Sickness, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetazolamideDrug
Also called Acetazolamide, oral capsule
Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m.
PlaceboDrug
Also called Placebo, oral capsule
Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses 1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m.
| Study group | Role | What they receive |
|---|---|---|
| Acetazolamide | Active comparator | Acetazolamide (oral capsules) Receives: Drug: Acetazolamide |
| Placebo | Placebo comparator | Placebo (oral capsules) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of altitude-related adverse health effects
Difference between participants receiving acetazolamide and placebo in the incidence of altitude-related adverse health effects defined as:
- Moderate to severe acute mountain sickness (Lake Louise score >4 including headache and/or Acute Mountain Sickness cerebral score ≥0.7)
- Severe hypoxemia (SpO2 at rest <80% for >30 min; or SpO2 <75% for >15 min; or 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 >120 mmHg, chest pain with ECG signs of cardiac ischemia)
- New onset neurologic impairment
- Other intercurrent illness requiring medical treatment
- Any discomfort leading to the wish of a patient to return to low altitude or withdraw from the study by the independent physician
Measured: Day 1 to 3 at 3'100m
Secondary outcomes (5)
Incidence and severity of the individual components of altitude-related adverse health effects
Difference between participants receiving acetazolamide and placebo in the incidence and severity of components of altitude-related adverse health effects
Measured: Day 1 to 3 at 3'100m
Arterial blood gases
Difference between participants receiving acetazolamide and placebo in arterial blood gases
Measured: Day 2 at 3'100 m
Forced expiratory volume in one second (FEV1)
Difference between participants receiving acetazolamide and placebo in forced expiratory volume in one second (FEV1) measured by spirometry
Measured: Day 2 at 3'100 m
Forced vital capacity (FVC)
Difference between participants receiving acetazolamide and placebo in forced vital capacity (FVC) measured by spirometry
Measured: Day 2 at 3'100 m
Drug side effects
Difference between participants receiving acetazolamide and placebo in the incidence of drug side effects
Measured: Day 1 to 3 at 3'100m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 Jun 2021
- Primary completion10 Aug 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, placebo-controlled, double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine, Kyrgyz Republic
- Responsible party
- Sponsor
- Investigators
- Konrad E Bloch, Study chair, University Hospital, Zürich, SwitzerlandTalant M Sooronbaev, Study director, National Center of Cardiology and Internal Medicine, Bishkek, KyrgyzstanMichael Furian, Principal investigator, University Hospital, Zürich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04913389
- Sponsor's protocol ID
- 01-2021-KEB
- Status last verified
- Mar 2023
- First submitted
- 23 May 2021
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Approach to Prevention of Altitude-related Illness in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04913389
- Acronym / sponsor ID
- 01-2021-KEB
- Keywords
- Acetazolamide, Mountain sickness, Hypoxemia, Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine, Kyrgyz Republic
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Jun 2021 (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.
The purpose of this randomized, placebo-controlled double-blind trial is to evaluate efficacy of acetazolamide in preventing overt altitude-related adverse health effects (ARAHE) in lowlanders with chronic obstructive pulmonary disease (COPD) developing early signs of altitude-illness during altitude travel.
Detailed description
This randomized placebo-controlled, double-blind, parallel-design trial will evaluate effectiveness of acetazolamide in reducing the incidence of predefined altitude-related adverse health effects in lowlanders with chronic obstructive pulmonary disease (COPD) travelling to high altitude and developping early symptoms and/or signs of impending altitude-illness. Qualifying participants will be randomized 1:1 to acetazolamide or placebo treatment during their further stay of 2 days at 3'100 m.
An interim-analysis will be performed after the first year of the study or when 38 participants are randomized, whichever comes first. Symmetric stopping boundaries at P<0.001 will be applied (Peto approach).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, placebo-controlled, double-blind
| Arm | Type | Receives |
|---|---|---|
| Acetazolamide | Active comparator | Drug: AcetazolamideAcetazolamide (oral capsules) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (oral capsules) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women, age 35-75 y, living at low altitude (<800 m).
- COPD diagnosed according to the Global Initiative for Obstructive Lung Disease (GOLD) guidelines, forced expiratory volume in one second 40-80% predicted, pulse oximetry ≥92%, PaCO2 <6 kilopascal, breathing ambient air at 760 m.
- One of the following early signs and/or symptoms of impending altitude-illness identified by self-monitoring during ascent to or stay at 3100 m:
Key exclusion criteria (4 listed)
- COPD exacerbation, very severe COPD with hypoxemia or hypercapnia at 760 m (see above).
- Other lung disease, relevant comorbidities (such as uncontrolled cardiovascular disease, i.e., unstable arterial hypertension, coronary artery disease; previous stroke; obesity (body mass index >35 kg/m2); internal, neurologic, rheumatologic or psychiatric disease; current heavy smoking (>20 cigarettes per day).
- Renal failure and/or allergy to sulfonamides.
- Patients who do not have early signs and/or signs of impending altitude-illness by self-monitoring (as defined above) at 3'100m will not be included.
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 |
|---|---|---|
| AcetazolamideAlso: Acetazolamide, oral capsuleAcetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m. | Drug | Acetazolamide |
| PlaceboAlso: Placebo, oral capsulePlacebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses 1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m. | Drug | Placebo |
Primary outcome
Incidence of altitude-related adverse health effects
Time frame: Day 1 to 3 at 3'100m
Difference between participants receiving acetazolamide and placebo in the incidence of altitude-related adverse health effects defined as: * Moderate to severe acute mountain sickness (Lake Louise score >4 including headache and/or Acute Mountain Sickness cerebral score ≥0.7) * Severe hypoxemia (SpO2 at rest <80% for >30 min; or SpO2 <75% for >15 min; or 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 >120 mmHg, chest pain with ECG signs of cardiac ischemia) * New onset neurologic impairment * Other intercurrent illness requiring medical treatment * Any discomfort leading to the wish of a patient to return to low altitude or withdraw from the study by the independent physician
5 secondary outcomes
Incidence and severity of the individual components of altitude-related adverse health effects
Time frame: Day 1 to 3 at 3'100m
Arterial blood gases
Time frame: Day 2 at 3'100 m
Forced expiratory volume in one second (FEV1)
Time frame: Day 2 at 3'100 m
Forced vital capacity (FVC)
Time frame: Day 2 at 3'100 m
Drug side effects
Time frame: Day 1 to 3 at 3'100m
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
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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 study chair
University Hospital, Zürich, Switzerland
Talant M Sooronbaev study director
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
Michael Furian principal investigator
University Hospital, Zürich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetazolamide in people with Chronic Obstructive Pulmonary Disease and Altitude Sickness, 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 5 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: status not confirmed, as of the sponsor's last update on 3 Mar 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Incidence of altitude-related adverse health effects (time frame: Day 1 to 3 at 3'100m). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2023.