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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03177811
Other study ID # 2017-00137B
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 24, 2017
Est. completion date August 2, 2018

Study information

Verified date October 2021
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date August 2, 2018
Est. primary completion date August 2, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ACETAZOLAMIDE oral capsule
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
Placebo oral capsule
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m

Locations

Country Name City State
Kyrgyzstan National Center of Cardiology and Internal Medicine Bishkek

Sponsors (2)

Lead Sponsor Collaborator
University of Zurich National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov

Country where clinical trial is conducted

Kyrgyzstan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in postural control 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 Day 2 at 760m and 3200m
Secondary Change in arterial oxygen saturation 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 Day 2 at 760m and 3200m
Secondary acute mountain sickness 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 Day 2 at 3200m
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