NCT03156231

Effect Of Acetazolamide On Altitude Related Illness In Patients With Respiratory Disease

Acetazolamide for Prevention of Altitude Related Illness in Patients With Chronic Obstructive Pulmonary Disease (COPD). Randomized, Placebo-Controlled, Double-Blind Trial.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Randomized, placebo controlled trial evaluating efficacy of acetazolamide in preventing altitude related adverse health effects (ARAHE) in lowlanders with chronic obstructive lung disease travelling from 760 m to 3200 m.

Detailed description

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of acetazolamide prophylaxis in reducing the incidence of altitude related adverse health effects (ARAHE) 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 before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m. An interim analysis will be carried out when 90 patients will have completed the study or after the first year. The Peto's method will be used to correct the P-values.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	ACETAZOLAMIDE oral capsule	Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
DRUG	Placebo oral capsule	Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m

Timeline

• Start date: 2017-05-24
• Primary completion: 2018-08-02
• Completion: 2018-08-02
• First posted: 2017-05-17
• Last updated: 2019-01-29

Locations

1 site across 1 country: Kyrgyzstan