Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD (NCT04913389) | Clinical Trial Compass
UnknownPhase 3
Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD
Kyrgyzstan100 participantsStarted 2021-06-01
Plain-language 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.
Who can participate
Age range35 Years ā 75 Years
SexALL
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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 ā„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 SpO2ā¤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.
What they're measuring
1
Incidence of altitude-related adverse health effects