Trial intelligence / Profile preview

Acetazolamide for Prevention of Altitude Illness in COPD

NCT03156231Phase 4

Key facts

Status: Completed
Start: May 2017
Primary completion: Aug 2018
Countries: 1
Sponsor: University of Zurich
Modality: Small Molecules

Drugs: acetazolamide
Conditions: Altitude sickness (AMS)acute mountain sickness (AMS)

Overview

Phase 4, randomised, double-blind trial in Altitude sickness (AMS) and acute mountain sickness (AMS) comparing Acetazolamide with Placebo (2 arms). Primary endpoint: Altitude related adverse health effects (ARAHE), cumulative incidence. Started May 2017; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Acetazolamide
Acetazolamide 375mg/day
Placebo
Placebo capsules

Who it enrols

Patients with COPD (FEV1 40-80%) living at low altitude, excluding those with severe hypoxemia, uncontrolled cardiovascular disease, or heavy smoking.

Endpoints

Primary

Altitude related adverse health effects (ARAHE), cumulative incidenceDay 1 to 3 at 3200m

Secondary

Acute mountain sickness, severityDay 1 to 3 at 3200m
6 min walk distanceDay 2 at 760m and 3200m
Perceived exertionDay 2 at 760m and 3200m
SpirometryDay 2 at 760m and 3200m
Arterial blood gasesDay 2 at 760m and 3200m
Exercise endurance during constant load cycling ergometryDay 3 at 760m and 3200m
Side effectsDay 1 to 3 at 3200m

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