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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
100
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.
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.
National Center of Cardiology and Internal Medicine
Bishkek, Kyrgyzstan
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
Time frame: Day 1 to 3 at 3'100m
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
Time frame: Day 1 to 3 at 3'100m
Arterial blood gases
Difference between participants receiving acetazolamide and placebo in arterial blood gases
Time frame: 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
Time frame: 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
Time frame: Day 2 at 3'100 m
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Drug side effects
Difference between participants receiving acetazolamide and placebo in the incidence of drug side effects
Time frame: Day 1 to 3 at 3'100m