Chronic Obstructive Pulmonary Disease
Conditions
Keywords
sleep related breathing disturbances, respiratory polygraphy, airway disease, emphysema, acetazolamide, altitude, nocturnal pulse oxymetry
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.
Interventions
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
DRUGPlacebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Sponsors
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in nocturnal oxygen saturation | night 1 at 760m and night 1 at 3200 m | Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group |
| Change in nocturnal oxygen desaturation index | night 1 at 760m and night 1 at 3200 m | Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in nocturnal oxygen saturation | night 1 at 760m and night 2 at 3200 m | Difference in altitude-induced change in mean nocturnal oxygen saturation measured by pulse oximetry between acetazolamide and placebo group |
| Change in nocturnal oxygen desaturation index | night 1 at 760m and night 2 at 3200 m | Difference in altitude-induced change in the mean number of cyclic dips in oxygen saturation measured by pulse oximetry between acetazolamide and placebo group |
| Change in apnea/hypopnea index | night 1 at 760m and night 1 at 3200 m | Difference in altitude-induced change in mean number of apneas/hypopneas per hour between the acetazolamide and placebo group |
| Change in subjective sleepiness and sleep quality | Day 1 and 2 at 760m and 3200m | Difference in altitude-induced change in subjective sleepiness and sleep quality assessed by a visual analog scale between acetazolamide and placebo group |
Countries
Kyrgyzstan
Outcome results
None listed