Acetazolamide to Prevent Impending Altitude-illness in Patients With COPD

Phase 3

Active, not recruiting

• Conditions: Altitude Sickness; Chronic Obstructive Pulmonary Disease; Altitude Hypoxia
• Interventions: Drug: Acetazolamide; Drug: Placebo

• Registration Number: NCT04913389
• Lead Sponsor: University of Zurich

Brief 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).

Study Timeline

• Study First Submitted: 2021-05-23
• Study Start: 2021-06-01
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-04
• Primary Completion: 2022-08-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acetazolamide	Acetazolamide	Acetazolamide (oral capsules)
Placebo	Placebo	Placebo (oral capsules)

Primary Outcome Measures

Name	Time	Method
Incidence of altitude-related adverse health effects	Day 1 to 3 at 3'100m	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

Secondary Outcome Measures

Name	Time	Method
Arterial blood gases	Day 2 at 3'100 m	Difference between participants receiving acetazolamide and placebo in arterial blood gases
Drug side effects	Day 1 to 3 at 3'100m	Difference between participants receiving acetazolamide and placebo in the incidence of drug side effects
Forced expiratory volume in one second (FEV1)	Day 2 at 3'100 m	Difference between participants receiving acetazolamide and placebo in forced expiratory volume in one second (FEV1) measured by spirometry
Forced vital capacity (FVC)	Day 2 at 3'100 m	Difference between participants receiving acetazolamide and placebo in forced vital capacity (FVC) measured by spirometry
Incidence and severity of the individual components of altitude-related adverse health effects	Day 1 to 3 at 3'100m	Difference between participants receiving acetazolamide and placebo in the incidence and severity of components of altitude-related adverse health effects

Trial Locations

Locations (1)

National Center of Cardiology and Internal Medicine; 🇰🇬 Bishkek, Kyrgyzstan