Dexamethasone for Prophylaxis of Acute Mountain Sickness in Patients With Chronic Obstructive Pulmonary Disease Travelling to Altitude
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- Acute mountain sickness, cumulative incidence
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dexamethasone
Dexamethasone 4 mg capsules, twice per day, orally
Intervention: Dexamethasone (Drug)
Placebo
Placebo capsules twice per day, orally
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Acute mountain sickness, cumulative incidence
Time Frame: day 3 at 3200 m
Difference between dexamethasone and placebo group in cumulative incidence of acute mountain sickness assessed by the environmental symptoms questionnaire cerebral subscale (score \>=0.7)
Secondary Outcomes
- Spirometry(Day 2 at 3200 m)
- Arterial blood gases(Day 2 at 3200 m)
- Acute mountain sickness, severity(day 1, day 2, day 3 at 3200 m)
- 6 min walk distance(Day 2 at 3200 m)
- Severe hypoxemia(day 1 to 3 at 3200m)
- Perceived exertion(Day 2 at 3200 m)