Clinical trial NCT03177850: Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Respiratory Disease at Altitude
Official title: Effect of Acetazolamide on Sleep Related Breathing Disturbances in Patients With Chronic Obstructive Pulmonary Disease at Altitude, Assessed by Respiratory Polygraphy: A Randomized, Placebo-controlled, Double-blind Parallel Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: sleep related breathing disturbances
respiratory polygraphy
airway disease
emphysema
acetazolamide
altitude
nocturnal pulse oxymetry
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2017-06-06
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances at altitude in patients with COPD.

Detailed description: This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on sleep related breathing disturbances in lowlanders with chronic obstructive pulmonary disease travelling to altitude. Participants living in the Bishkek area, Kyrgyzstan (760m), will be transferred by car within 4h to the Tuja Ashu high altitude clinic (3200 m), and stay there for 2 days. Acetazolamide 375mg/day (or placebo), will be administered 24 hours before departure at 760 m and during the stay at altitude. Outcomes will be assessed during the stay at 3200 m.

Sleep related breathing disturbances will be evaluated by respiratory polygraphy.

An interim analysis will be carried out when 90 patients will have completed the study or after the first year. The Peto's method will be used to correct the P-values.

Eligibility criteria: Inclusion Criteria:

* Male and female patients, age 18-75 yrs.
* COPD diagnosed according to GOLD, FEV1 40-80% predicted, SpO2 ≥92% at 750 m.
* Born, raised and currently living at low altitude (\<800m).
* Written informed consent.

Exclusion Criteria:

* COPD exacerbation, very severe COPD with hypoxemia at low altitude (FEV1/FVC \<0.7, FEV1 \<40% predicted, oxygen saturation on room air \<92% at 750 m).
* Comorbidities such as uncontrolled cardiovascular disease, i.e., unstable systemic arterial hypertension, coronary artery disease; previous stroke; OSA; pneumothorax in the last 2 months.
* Internal, neurologic, rheumatologic or psychiatric disease including current heavy smoking (\>20 cigarettes per day)
* Known renal failure or allergy to acetazolamide and other sulfonamides

Primary outcomes:
measure: Change in nocturnal oxygen saturation
timeFrame: night 1 at 760m and night 1 at 3200 m
measure: Change in nocturnal oxygen desaturation index
timeFrame: night 1 at 760m and night 1 at 3200 m
Secondary outcomes:
measure: Change in nocturnal oxygen saturation
timeFrame: night 1 at 760m and night 2 at 3200 m
measure: Change in nocturnal oxygen desaturation index
timeFrame: night 1 at 760m and night 2 at 3200 m
measure: Change in apnea/hypopnea index
timeFrame: night 1 at 760m and night 1 at 3200 m
measure: Change in apnea/hypopnea index
timeFrame: night 1 at 760m and night 2 at 3200 m
measure: Change in subjective sleepiness and sleep quality
timeFrame: Day 1 and 2 at 760m and 3200m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center of Cardiology and Internal Medicine
Study officials:
affiliation: University of Zurich
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: