Clinical trial NCT02450994: Effect of Dexamethasone on Sleep Related Breathing Disturbances in Patients With COPD at Altitude
Official title: Dexamethasone for Prophylaxis of Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease (COPD) Travelling to Altitude
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: airway disease
bronchitis
emphysema
lung
treatment
sleep
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2015-05-21
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: night 1 at 3200 m
Secondary outcomes:
measure: Oxygen desaturation index
timeFrame: night 1 at 3200 m
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: night 2 at 3200 m
measure: Apnea/hypopnea index
timeFrame: night 2 at 3200 m
measure: Apnea/hypopnea index
timeFrame: night 1 at 3200 m
measure: Oxygen desaturation index
timeFrame: night 2 at 3200 m
measure: Mean nocturnal oxygen saturation measured by pulse oximetry
timeFrame: night 1 at 700 m
measure: Oxygen desaturation index
timeFrame: night 1 at 700 m
measure: Apnea/hypopnea index
timeFrame: night 1 at 700 m
measure: Psychomotor vigilance test reaction time
timeFrame: day 2 at 700 m
measure: Subjective sleepiness
timeFrame: day 2 at 700 m
measure: Subjective sleepiness
timeFrame: day 2 at 3200 m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center of Cardiology and Internal Medicine
Study officials:
affiliation: University Hospital, Zürich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant M Sooronbaev, MD
role: STUDY_DIRECTOR
References:
citation: Furian M, Lichtblau M, Aeschbacher SS, Estebesova B, Emilov B, Sheraliev U, Marazhapov NH, Mademilov M, Osmonov B, Bisang M, Ulrich S, Latshang TD, Ulrich S, Sooronbaev TM, Bloch KE. Effect of Dexamethasone on Nocturnal Oxygenation in Lowlanders With Chronic Obstructive Pulmonary Disease Traveling to 3100 Meters: A Randomized Clinical Trial. JAMA Netw Open. 2019 Feb 1;2(2):e190067. doi: 10.1001/jamanetworkopen.2019.0067.