National Center of Cardiology and Internal Medicine
Bishkek, 720040, Kyrgyzstan
NCT Number: NCT03177811
In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on postural control at acute altitude exposure in patients with COPD.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Bishkek, 720040, Kyrgyzstan
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on postural control at altitude (Tuja Ashu, 3200 m). 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 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m. Randomization to acetazolamide or placebo will be carried out after baseline measurements in Bishkek (760 m).
Postural control will be assessed by a rectangular, stable balance platform (Wii Balance Board) measuring the body's center of gravity. The movement of the body's center of gravity will be recorded in a two-dimensional coordinate system and indicated as path length.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Time frame: Day 2 at 760m and 3200m
Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3200 meters a.s.l.) of center of gravity displacement between acetazolamide and placebo group, measured by a balance platform
Time frame: Day 2 at 760m and 3200m
Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3200 meters a.s.l.) of arterial oxygen saturation between acetazolamide and placebo group, measured by pulse oximetry
Time frame: Day 2 at 3200m
Difference in acute mountain sickness severity on day 2 at 3200 meters a.s.l. between acetazolamide and placebo group, measured by the environmental symptoms questionnaire cerebral subscore
University of Zurich
Other
Effect of Acetazolamide on Postural Control in Patients With Chronic Obstructive Pulmonary Disease at Altitude: A Randomized, Placebo-controlled, Double-blind Parallel Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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