Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Randomized, placebo controlled trial evaluating efficacy of dexamethasone in preventing sleep related breathing disturbances in lowlanders with chronic obstructive lung disease travelling from 700 m to 3200 m.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Collaborator: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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