Altitude Related Illness In Patients With Respiratory Disease

Study Overview
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Brief Summary
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Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing acute mountain sickness in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.

Detailed Description
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This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of dexamethasone prophylaxis in reducing the incidence of acute mountain sickness in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (700m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Dexamethasone 2x4mg/day (or placebo), will be administered before departure at 700 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

Official Title
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Dexamethasone for Prophylaxis of Acute Mountain Sickness in Patients With Chronic Obstructive Pulmonary Disease Travelling to Altitude

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2 Living at low altitude (<800m) Exclusion Criteria: COPD exacerbation severe COPD, GOLD grade 3 or 4 arterial oxygen saturation <92% at low altitude (<800 m) Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months, untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnea. Internal, neurologic or psychiatric disease that interfere with protocol compliance including current heavy smoking (>20 cigarettes per day). pregnant or nursing patients

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone<br>Dexamethasone 4 mg capsules, twice per day, orally | Drug: Dexamethasone<br> <br> |
| Placebo Comparator: Placebo<br>Placebo capsules twice per day, orally | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute mountain sickness, cumulative incidence | Difference between dexamethasone and placebo group in cumulative incidence of acute mountain sickness assessed by the environmental symptoms questionnaire cerebral subscale (score >=0.7) | day 3 at 3200 m | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe hypoxemia | Number of participants in the dexamethasone and placebo group with arterial oxygen saturation measured by pulse oximetry less than 75% for more than 30 min or less than 70% for more than 15 min. | day 1 to 3 at 3200m | 
| Acute mountain sickness, severity | Difference between dexamethasone and placebo group in the acute mountain sickness severity assessed by the environmental symptoms questionnaire cerebral subscale | day 1, day 2, day 3 at 3200 m | 
| 6 min walk distance | Difference in the distance walked in 6 min between the dexamethasone and placebo group | Day 2 at 3200 m | 
| Perceived exertion | Difference in the perceived exertion rated with the Borg CR10 scale between the dexamethasone and placebo group | Day 2 at 3200 m | 
| Spirometry | Difference in the spirometric variables between the dexamethasone and placebo group | Day 2 at 3200 m | 
| Arterial blood gases | Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the dexamethasone and placebo group | Day 2 at 3200 m | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway disease, bronchitis, emphysema, lung, treatment