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COMPLETEDPhase 4NCT02450968

Altitude Related Illness In Patients With Respiratory Disease

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.

Lead sponsor: University of Zurich•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University of Zurich

Collaborators

National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

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.

Age

20 - 75 years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 17, 2017Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE4

Enrollment124

Start dateMay 2015

Last updatedMay 17, 2017

Condition

Chronic Obstructive Pulmonary Disease (COPD)

Locations shown

National Center of Cardiology and Internal Medicine

Bishkek

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 17, 2017Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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