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| Name | Class |
|---|---|
| National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACETAZOLAMIDE oral capsule | Active Comparator | Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m |
|
| PLACEBO oral capsule | Placebo Comparator | Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACETAZOLAMIDE oral capsule | Drug | Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in postural control | 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 | Day 2 at 760m and 3200m |
| Measure | Description | Time Frame |
|---|---|---|
| Change in arterial oxygen saturation | 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 | Day 2 at 760m and 3200m |
| acute mountain sickness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konrad E Bloch, MD | University of Zurich | Study Chair |
| Talant M Sooronbaev, MD | National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Center of Cardiology and Internal Medicine | Bishkek | 720040 | Kyrgyzstan |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo oral capsule | Drug | Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 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 |
| Day 2 at 3200m |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |