NCT03539367

Effect of Acetazolamide on Lung Water Content by Ultrasound in Lowlanders Older Than 40 Years at Altitude

Effect of Acetazolamide on Lung Water Content by Ultrasound in Lowlanders Older Than 40 Years at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Accepted

Summary

Randomized, placebo controlled trial evaluating the effect of acetazolamide on lung water content by ultrasound in lowlanders older than 40 years travelling from 760 m to 3'100 m.

Detailed description

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of preventive acetazolamide intake on lung water content by ultrasound in lowlanders older than 40 years 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 (3'100 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3'100 m. An interim analysis will be carried out when 200 participants will have completed the study and/or after the first year. The Peto's method will be used and the trial will be stopped when pre-specified futility boundaries were crossed.

Conditions

• Altitude Hypoxia

Interventions

Type	Name	Description
DRUG	ACETAZOLAMIDE oral capsule	Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
DRUG	Placebo oral capsule	Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m

Timeline

• Start date: 2018-06-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-05-29
• Last updated: 2022-11-02

Locations

1 site across 1 country: Kyrgyzstan