Status:
UNKNOWN
Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
National Center of Cardiology and Internal Medicine, Kyrgyz Republic
Conditions:
Chronic Obstructive Pulmonary Disease
Altitude Sickness
Eligibility:
All Genders
35-75 years
Phase:
PHASE3
Brief 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 ch...
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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
- Exclusion criteria
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04913389
Start Date
June 1 2021
End Date
December 31 2023
Last Update
March 3 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Center of Cardiology and Internal Medicine
Bishkek, Kyrgyzstan, 720040