Effect of Acetazolamide on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease at Altitude, Assessed by Maximal Cycling Spiroergometry: A Randomized, Placebo-controlled, Double-blind Parallel Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Zurich
- Enrollment
- 176
- Locations
- 1
- Primary Endpoint
- Change in maximal power output during exercise
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
ACETAZOLAMIDE oral capsule
Acetazolamide 375mg/day (capsule @125 mg: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m
Intervention: ACETAZOLAMIDE oral capsule (Drug)
PLACEBO oral capsule
Placebo (capsules identically looking as acetazolamide capsules: 1 in the morning, 2 in the evening), orally. Medication starts 24 hours before ascent to 3200m until the morning after the second night at 3200m.
Intervention: Placebo oral capsule (Drug)
Outcomes
Primary Outcomes
Change in maximal power output during exercise
Time Frame: Day 1 at 760m and day 1 at 3200m
Difference in altitude-induced change in maximal power output between acetazolamide and placebo group.
Secondary Outcomes
- Change in peak oxygen uptake during exercise(Day 1 at 760m and day 1 at 3200m)
- Change in cerebral tissue oxygenation during exercise(Day 1 at 760m and day 1 at 3200m)
- Change in muscle tissue oxygenation during exercise(Day 1 at 760m and day 1 at 3200m)
- Change in exercise endurance during constant load cycling ergometry(Day 3 at 760m and day 1 at 3200m)