Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease at Altitude, Assessed by Respiratory Polygraphy: A Randomized, Placebo-controlled, Double-blind Parallel Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Change in nocturnal oxygen saturation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients, age 18-75 yrs.
- •COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
- •Born, raised and currently living at low altitude (<800m).
- •Written informed consent.
排除标准
- •COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC <0.7, FEV1 <40% predicted, oxygen saturation on room air <92% at 750 m).
- •Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
- •Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (>20 cigarettes per day)
- •Known renal failure or allergy to acetazolamide and other sulfonamides
研究组 & 干预措施
ACETAZOLAMIDE oral capsule
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
干预措施: ACETAZOLAMIDE oral capsule (Drug)
PLACEBO oral capsule
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.
干预措施: Placebo oral capsule (Drug)
结局指标
主要结局
Change in nocturnal oxygen saturation
时间窗: night 1 at 760m and night 1 at 3200 m
Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
Change in nocturnal oxygen desaturation index
时间窗: night 1 at 760m and night 1 at 3200 m
Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group
次要结局
- Change in nocturnal oxygen desaturation index(night 1 at 760m and night 2 at 3200 m)
- Change in apnea/hypopnea index(night 1 at 760m and night 2 at 3200 m)
- Change in subjective sleepiness and sleep quality(Day 1 and 2 at 760m and 3200m)
- Change in nocturnal oxygen saturation(night 1 at 760m and night 2 at 3200 m)