Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
airway disease, bronchitis, emphysema, lung, treatment
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.
Interventions
DRUGDexamethasone
DRUGPlacebo
Sponsors
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute mountain sickness, cumulative incidence | 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
| Measure | Time frame | Description |
|---|---|---|
| Acute mountain sickness, severity | day 1, day 2, day 3 at 3200 m | Difference between dexamethasone and placebo group in the acute mountain sickness severity assessed by the environmental symptoms questionnaire cerebral subscale |
| Severe hypoxemia | day 1 to 3 at 3200m | 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. |
| 6 min walk distance | Day 2 at 3200 m | Difference in the distance walked in 6 min between the dexamethasone and placebo group |
| Spirometry | Day 2 at 3200 m | Difference in the spirometric variables between the dexamethasone and placebo group |
| Arterial blood gases | Day 2 at 3200 m | Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the dexamethasone and placebo group |
| Perceived exertion | Day 2 at 3200 m | Difference in the perceived exertion rated with the Borg CR10 scale between the dexamethasone and placebo group |
Countries
Kyrgyzstan
Outcome results
None listed