Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Keywords
cognition, visuomotor learning, airway disease, altitude, prevention, acetazolamide
Brief summary
Randomized, placebo controlled trial evaluating the effect of acetazolamide on cognition in lowlanders with chronic obstructive pulmonary disease travelling from 760 m to 3200 m.
Detailed description
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on visuomotor learning performance at altitude (Tuja Ashu, 3200 m). Randomization to acetazolamide or placebo will be carried out after baseline measurements in Bishkek (760 m). Visuomotor learning performance will be tested by Motor Task Manager (MTM). The MTM requires the subjects to reach visual targets with a hand-held cursor. During progression of the test, the movement direction from the cursor on the computer screen will increasingly differ from the direction of the hand movement, forcing the unaware subject to implicitly adapt to the imposed cursor rotation. This test assesses a subjects ability to visuomotor adaption, perception and attention. Furthermore, as the task will be performed in the evening and after sleep in the next morning, the investigators will be able to assess overnight improvement of implicit learned skills.
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 |
|---|---|---|
| visuomotor learning performance, drug effect | Day 2 at 760m and 3200m | Difference in altitude-induced change in directional error between acetazolamide and placebo group, measured by the motor task manager |
| visuomotor learning performance, altitude effect | Day 1 and 2 at 760 m and at 3200m | Difference in directional error between 760 m and 3200 m altitude in placebo group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| arterial oxygen saturation | Day 1 and 2 at 760 m and at 3200m | Difference in altitude-induced change of arterial oxygen saturation between acetazolamide and placebo group, measured by pulse oxymetry |
Countries
Kyrgyzstan
Outcome results
None listed