Altitude Related Illness In Patients With Respiratory Disease

University of Zurich (UZH) logo

University of Zurich (UZH)

Status and phase

Completed
Phase 4

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Dexamethasone
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02450968
EK15-2015

Details and patient eligibility

About

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.

Full 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.

Enrollment

124 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

124 participants in 2 patient groups, including a placebo group

Dexamethasone
Active Comparator group
Description:
Dexamethasone 4 mg capsules, twice per day, orally
Treatment:
Drug: Dexamethasone
Placebo
Placebo Comparator group
Description:
Placebo capsules twice per day, orally
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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