Overview

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