Altitude Related Illness In Patients With Respiratory Disease

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Dexamethasone; Drug: Placebo

• Registration Number: NCT02450968
• Lead Sponsor: University of Zurich

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-18
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-21
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-16
• Last Update Posted: 2017-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Chronic obstructive pulmonary disease (COPD), GOLD grade 1-2
• Living at low altitude (<800m)

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	Dexamethasone 4 mg capsules, twice per day, orally
Placebo	Placebo	Placebo capsules twice per day, orally

Primary Outcome Measures

Name	Time	Method
Acute mountain sickness, cumulative incidence	day 3 at 3200 m	Difference between dexamethasone and placebo group in cumulative incidence of acute mountain sickness assessed by the environmental symptoms questionnaire cerebral subscale (score \>=0.7)

Secondary Outcome Measures

Name	Time	Method
Arterial blood gases	Day 2 at 3200 m	Difference in arterial oxygen partial pressure, carbon dioxide partial pressure, and pH between the dexamethasone and placebo group
Acute mountain sickness, severity	day 1, day 2, day 3 at 3200 m	Difference between dexamethasone and placebo group in the acute mountain sickness severity assessed by the environmental symptoms questionnaire cerebral subscale
6 min walk distance	Day 2 at 3200 m	Difference in the distance walked in 6 min between the dexamethasone and placebo group
Spirometry	Day 2 at 3200 m	Difference in the spirometric variables between the dexamethasone and placebo group
Severe hypoxemia	day 1 to 3 at 3200m	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.
Perceived exertion	Day 2 at 3200 m	Difference in the perceived exertion rated with the Borg CR10 scale between the dexamethasone and placebo group

Trial Locations

Locations (1)

National Center of Cardiology and Internal Medicine; 🇰🇬 Bishkek, Kyrgyzstan