Chronic Obstructive Pulmonary Disease
Conditions
Keywords
postural control, balance performance, airway disease, altitude, prevention, acetazolamide
Brief summary
In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on postural control at acute altitude exposure 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 postural control at altitude (Tuja Ashu, 3200 m). 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. Randomization to acetazolamide or placebo will be carried out after baseline measurements in Bishkek (760 m). Postural control will be assessed by a rectangular, stable balance platform (Wii Balance Board) measuring the body's center of gravity. The movement of the body's center of gravity will be recorded in a two-dimensional coordinate system and indicated as path length.
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 postural control | Day 2 at 760m and 3200m | Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3200 meters a.s.l.) of center of gravity displacement between acetazolamide and placebo group, measured by a balance platform |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in arterial oxygen saturation | Day 2 at 760m and 3200m | Difference in altitude-induced change (between day 2 at 760 meters a.s.l. vs. day 2 at 3200 meters a.s.l.) of arterial oxygen saturation between acetazolamide and placebo group, measured by pulse oximetry |
| acute mountain sickness | Day 2 at 3200m | Difference in acute mountain sickness severity on day 2 at 3200 meters a.s.l. between acetazolamide and placebo group, measured by the environmental symptoms questionnaire cerebral subscore |
Countries
Kyrgyzstan
Outcome results
None listed