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. 2019 Apr 23;2019(4):CD013315. doi: 10.1002/14651858.CD013315

NCT02450968.

Trial name or title Dexamethasone for prophylaxis of acute mountain sickness in patients with chronic obstructive pulmonary disease travelling to altitude
Methods Interventional
Participants Inclusion criteria
  1. Chronic obstructive pulmonary disease (COPD), GOLD criteria grade 1 or 2

  2. Living at low altitude (< 800m)


Exclusion criteria
  1. COPD exacerbation

  2. severe COPD, GOLD grade 3 or 4

  3. Arterial oxygen saturation < 92% at low altitude (< 800 metres)

  4. Diabetes, uncontrolled cardiovascular disease such as systemic arterial hypertension, coronary artery disease; previous stroke; pneumothorax in the last 2 months

  5. Untreated or symptomatic peptic ulcer disease, glaucoma, obstructive sleep apnoea

  6. Internal, neurologic or psychiatric disease that interferes with protocol compliance including current heavy smoking (> 20 cigarettes per day)

  7. Pregnant or nursing mothers


Age minimum: 20 years old
Age maximum: 75 years old
Gender: both
Interventions
  1. Drug: dexamethasone

  2. Drug: placebo

Outcomes
  1. Acute mountain sickness, cumulative risk (time frame: day 3 at 3200 m)

  2. 6 minutes walk distance (time frame: day 2 at 3200 m)

  3. Acute mountain sickness, severity (time frame: day 1, day 2, day 3 at 3200 m)

  4. Arterial blood gases (time frame: day 2 at 3200 m)

  5. Perceived exertion (time frame: day 2 at 3200 m)

Starting date May 2015
Contact information Talant M Sooronbaev, MD
Notes Recruiting