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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
185
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
National Center of Cardiology and Internal Medicine
Bishkek, Kyrgyzstan
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
Time frame: Day 1 to 3 at 3200m
Acute mountain sickness, severity
Difference between acetazolamide and placebo group in the acute mountain sickness severity assessed by the Lake Louise questionnaire.
Time frame: 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.
Time frame: 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
Time frame: Day 2 at 760m and 3200m
Spirometry
Difference in altitude-induced change in the spirometric variables between the acetazolamide and placebo group
Time frame: Day 2 at 760m and 3200m
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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
Time frame: 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
Time frame: 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.
Time frame: Day 1 to 3 at 3200m