Novel Approach to Prevention of Altitude-related Illness in Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of altitude-related adverse health effects
研究概览
简要总结
The purpose of this randomized, placebo-controlled double-blind trial is to evaluate efficacy of acetazolamide in preventing overt altitude-related adverse health effects (ARAHE) in lowlanders with chronic obstructive pulmonary disease (COPD) developing early signs of altitude-illness during altitude travel.
详细描述
This randomized placebo-controlled, double-blind, parallel-design trial will evaluate effectiveness of acetazolamide in reducing the incidence of predefined altitude-related adverse health effects in lowlanders with chronic obstructive pulmonary disease (COPD) travelling to high altitude and developping early symptoms and/or signs of impending altitude-illness. Qualifying participants will be randomized 1:1 to acetazolamide or placebo treatment during their further stay of 2 days at 3'100 m.
An interim-analysis will be performed after the first year of the study or when 38 participants are randomized, whichever comes first. Symmetric stopping boundaries at P<0.001 will be applied (Peto approach).
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)
盲法说明
An independent pharmacist will prepare identically looking active and placebo capsules labelled with secret codes. Codes will be concealed to investigators and patients until completion of data analysis.
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Acetazolamide
Acetazolamide (oral capsules)
干预措施: Acetazolamide (Drug)
Placebo
Placebo (oral capsules)
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of altitude-related adverse health effects
时间窗: Day 1 to 3 at 3'100m
Difference between participants receiving acetazolamide and placebo in the incidence of altitude-related adverse health effects defined as: * Moderate to severe acute mountain sickness (Lake Louise score \>4 including headache and/or Acute Mountain Sickness cerebral score ≥0.7) * Severe hypoxemia (SpO2 at rest \<80% for \>30 min; or SpO2 \<75% for \>15 min; or exercise oxygen desaturation SpO2 \<75% for \>1 min accompanied by symptoms or signs of hypoxemia) * Symptomatic cardiovascular disease (arterial blood pressure systolic \>200 mmHg, diastolic \>120 mmHg, chest pain with ECG signs of cardiac ischemia) * New onset neurologic impairment * Other intercurrent illness requiring medical treatment * Any discomfort leading to the wish of a patient to return to low altitude or withdraw from the study by the independent physician
次要结局
- Arterial blood gases(Day 2 at 3'100 m)
- Drug side effects(Day 1 to 3 at 3'100m)
- Forced expiratory volume in one second (FEV1)(Day 2 at 3'100 m)
- Forced vital capacity (FVC)(Day 2 at 3'100 m)
- Incidence and severity of the individual components of altitude-related adverse health effects(Day 1 to 3 at 3'100m)