Altitude Related Illness In Patients With Respiratory Disease

University of Zurich124 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

124

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DexamethasoneDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

National Center of Cardiology and Internal Medicine

Bishkek, Kyrgyzstan

Outcomes

Primary Outcomes

Acute mountain sickness, cumulative incidence

Difference between dexamethasone and placebo group in cumulative incidence of acute mountain sickness assessed by the environmental symptoms questionnaire cerebral subscale (score \>=0.7)

Time frame: day 3 at 3200 m

Secondary Outcomes

Severe hypoxemia

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.

Time frame: day 1 to 3 at 3200m

Acute mountain sickness, severity

Difference between dexamethasone and placebo group in the acute mountain sickness severity assessed by the environmental symptoms questionnaire cerebral subscale

Time frame: day 1, day 2, day 3 at 3200 m

6 min walk distance

Difference in the distance walked in 6 min between the dexamethasone and placebo group

Time frame: Day 2 at 3200 m

Perceived exertion

Difference in the perceived exertion rated with the Borg CR10 scale between the dexamethasone and placebo group

Time frame: Day 2 at 3200 m

Spirometry

Difference in the spirometric variables between the dexamethasone and placebo group

Time frame: Day 2 at 3200 m

Arterial blood gases

Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the dexamethasone and placebo group

Data from ClinicalTrials.gov

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