Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Dexamethasone for Prophylaxis of Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease (COPD) Travelling to Altitude

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02450994
• Other study ID #: EK15-2015_V1
• Status: Completed
• Phase: Phase 4
• First received: May 18, 2015
• Last updated: December 18, 2015
• Start date: May 2015
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Description:

This is a randomized, placebo-controlled, double-blind parallel trial evaluating the efficacy of dexamethasone prophylaxis in sleep related breathing disturbances 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: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

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	Mean nocturnal oxygen saturation measured by pulse oximetry	Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group	night 1 at 3200 m	No
Secondary	Oxygen desaturation index	Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group	night 1 at 3200 m	No
Secondary	Mean nocturnal oxygen saturation measured by pulse oximetry	Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group	night 2 at 3200 m	No
Secondary	Apnea/hypopnea index	Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group	night 2 at 3200 m	No
Secondary	Apnea/hypopnea index	Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group	night 1 at 3200 m	No
Secondary	Oxygen desaturation index	Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group	night 2 at 3200 m	No
Secondary	Mean nocturnal oxygen saturation measured by pulse oximetry	Difference in mean nocturnal oxygen saturation between dexamethasone and placebo group	night 1 at 700 m	No
Secondary	Oxygen desaturation index	Difference in oxygen desaturation index (>3%) between dexamethasone and placebo group	night 1 at 700 m	No
Secondary	Apnea/hypopnea index	Difference in mean apneas/hypopneas per hour between the dexamethasone and placebo group	night 1 at 700 m	No
Secondary	Psychomotor vigilance test reaction time	Difference in reaction time during psychomotor vigilance test between dexamethasone and placebo group	day 2 at 700 m	No
Secondary	Subjective sleepiness	Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group	day 2 at 700 m	No
Secondary	Subjective sleepiness	Difference in subjective sleepiness and sleep quality assessed by a visual analog scale between dexamethasone and placebo group	day 2 at 3200 m	No