Clinical trial NCT03177837: Effect of Acetazolamide on Exercise Performance in Patients With Respiratory Disease at Altitude
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: exercise performance
maximal spiroergometry
airway disease
emphysema
prevention
acetazolamide
altitude
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2017-06-06
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in maximal power output during exercise
timeFrame: Day 1 at 760m and day 1 at 3200m
Secondary outcomes:
measure: Change in peak oxygen uptake during exercise
timeFrame: Day 1 at 760m and day 1 at 3200m
measure: Change in cerebral tissue oxygenation during exercise
timeFrame: Day 1 at 760m and day 1 at 3200m
measure: Change in muscle tissue oxygenation during exercise
timeFrame: Day 1 at 760m and day 1 at 3200m
measure: Change in exercise endurance during constant load cycling ergometry
timeFrame: Day 3 at 760m and day 1 at 3200m
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center of Cardiology and Internal Medicine
Study officials:
affiliation: University of Zurich
name: Konrad E Bloch, MD
role: STUDY_CHAIR
affiliation: National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
name: Talant M Sooronbaev, MD
role: STUDY_DIRECTOR
References: