Effect of Acetazolamide on Exercise Performance in Patients With Respiratory Disease at Altitude

University of Zurich176 enrolled

Overview

In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on exercise performance at altitude in patients with COPD.

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on exercise performance 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 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m. Exercise performance will be evaluated by maximal cycling spiroergometry and constant load ergometry.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

176

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

ACETAZOLAMIDE oral capsuleDRUG

Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m

Placebo oral capsuleDRUG

Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female patients, age 18-75 yrs. * COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m. * Born, raised and currently living at low altitude (\<800m). * Written informed consent. Exclusion Criteria: * COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC \<0.7, FEV1 \<40% predicted, oxygen saturation on room air \<92% at 750 m). * Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months. * Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day) * Known renal failure or allergy to acetazolamide and other sulfonamides

Locations (1)

National Center of Cardiology and Internal Medicine

Bishkek, Kyrgyzstan

Outcomes

Primary Outcomes

Change in maximal power output during exercise

Difference in altitude-induced change in maximal power output between acetazolamide and placebo group.

Time frame: Day 1 at 760m and day 1 at 3200m

Secondary Outcomes

Change in peak oxygen uptake during exercise

Difference in altitude-induced change in peak oxygen uptake between acetazolamide and placebo group.

Time frame: Day 1 at 760m and day 1 at 3200m

Change in cerebral tissue oxygenation during exercise

Difference in altitude-induced change in cerebral tissue oxygenation between acetazolamide and placebo, measured by near-infrared spectroscopy during cycle spiroergometry

Time frame: Day 1 at 760m and day 1 at 3200m

Change in muscle tissue oxygenation during exercise

Difference in altitude-induced change in muscular tissue oxygenation between acetazolamide and placebo, measured by near-infrared spectroscopy during cycle spiroergometry

Time frame: Day 1 at 760m and day 1 at 3200m

Change in 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 day 1 at 3200m

Data from ClinicalTrials.gov

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