Altitude Related Illness In Patients With Respiratory Disease

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Dexamethasone for Prophylaxis of Acute Mountain Sickness in Patients With Chronic Obstructive Pulmonary Disease Travelling to Altitude

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450968
• Other study ID #: EK15-2015
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2015
• Last updated: May 16, 2017
• Start date: May 2015
• Est. completion date: December 2015

Study information

• Verified date: May 2017
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Dexamethasone

• Placebo

Locations

Country	Name	City	State
Kyrgyzstan	National Center of Cardiology and Internal Medicine	Bishkek

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	National Center of Cardiology and Internal Medicine, Kyrgyzstan

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

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