NCT04913389

Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD

Novel Approach to Prevention of Altitude-related Illness in Patients With Chronic Obstructive Pulmonary Disease

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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 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).

Conditions

• Chronic Obstructive Pulmonary Disease
• Altitude Sickness
• Altitude Hypoxia

Interventions

Type	Name	Description
DRUG	Acetazolamide	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.
DRUG	Placebo	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.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-08-10
• Completion: 2023-12-31
• First posted: 2021-06-04
• Last updated: 2023-03-03

Locations

1 site across 1 country: Kyrgyzstan