Chronic Obstructive Pulmonary Disease
Conditions
Keywords
exercise performance, maximal spiroergometry, airway disease, emphysema, prevention, acetazolamide, altitude
Brief summary
In this trial, the investigators will evaluate the effect of acetazolamide (375 mg per day) vs. placebo on exercise performance 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 exercise performance 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. Exercise performance will be evaluated by maximal cycling spiroergometry and constant load ergometry.
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 maximal power output during exercise | Day 1 at 760m and day 1 at 3200m | Difference in altitude-induced change in maximal power output between acetazolamide and placebo group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in peak oxygen uptake during exercise | Day 1 at 760m and day 1 at 3200m | Difference in altitude-induced change in peak oxygen uptake between acetazolamide and placebo group. |
| Change in cerebral tissue oxygenation during exercise | Day 1 at 760m and day 1 at 3200m | Difference in altitude-induced change in cerebral tissue oxygenation between acetazolamide and placebo, measured by near-infrared spectroscopy during cycle spiroergometry |
| Change in muscle tissue oxygenation during exercise | Day 1 at 760m and day 1 at 3200m | Difference in altitude-induced change in muscular tissue oxygenation between acetazolamide and placebo, measured by near-infrared spectroscopy during cycle spiroergometry |
| Change in exercise endurance during constant load cycling ergometry | Day 3 at 760m and day 1 at 3200m | Difference in altitude-induced change in exercise endurance between acetazolamide and placebo group, measured by constant load cycling ergometry |
Countries
Kyrgyzstan
Outcome results
None listed