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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 sleep related breathing disturbances at altitude 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 sleep related breathing disturbances 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 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.
Sleep related breathing disturbances will be evaluated by respiratory polygraphy.
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.
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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 nocturnal oxygen saturation | Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group | night 1 at 760m and night 1 at 3200 m |
| Change in nocturnal oxygen desaturation index | Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group | night 1 at 760m and night 1 at 3200 m |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nocturnal oxygen saturation | Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group | night 1 at 760m and night 2 at 3200 m |
| Change in nocturnal oxygen desaturation index |
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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 |
| D004646 | Emphysema |
| 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 altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group |
| night 1 at 760m and night 2 at 3200 m |
| Change in apnea/hypopnea index | Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group | night 1 at 760m and night 1 at 3200 m |
| Change in apnea/hypopnea index | Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group | night 1 at 760m and night 2 at 3200 m |
| Change in subjective sleepiness and sleep quality | Difference in altitude-induced change in subjective sleepiness and sleep quality assessed by a visual analog scale between acetazolamide and placebo group | Day 1 and 2 at 760m and 3200m |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |