- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03165890
Effect of Acetazolamide on Cognition in Patients With Respiratory Disease at Altitude
Effect of Acetazolamide on Visuomotor Learning Performance in Patients With Chronic Obstructive Pulmonary Disease at Altitude
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized, placebo-controlled, double-blind parallel trial evaluating the effect of acetazolamide (375 mg per day) vs. placebo on visuomotor learning performance at altitude (Tuja Ashu, 3200 m). Randomization to acetazolamide or placebo will be carried out after baseline measurements in Bishkek (760 m).
Visuomotor learning performance will be tested by Motor Task Manager (MTM). The MTM requires the subjects to reach visual targets with a hand-held cursor. During progression of the test, the movement direction from the cursor on the computer screen will increasingly differ from the direction of the hand movement, forcing the unaware subject to implicitly adapt to the imposed cursor rotation. This test assesses a subjects ability to visuomotor adaption, perception and attention. Furthermore, as the task will be performed in the evening and after sleep in the next morning, the investigators will be able to assess overnight improvement of implicit learned skills.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Bishkek, Kyrgyzstan, 720040
- National Center of Cardiology and Internal Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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
|
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
|
Placebo Comparator: 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.
|
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
visuomotor learning performance, drug effect
Time Frame: Day 2 at 760m and 3200m
|
Difference in altitude-induced change in directional error between acetazolamide and placebo group, measured by the motor task manager
|
Day 2 at 760m and 3200m
|
visuomotor learning performance, altitude effect
Time Frame: Day 1 and 2 at 760 m and at 3200m
|
Difference in directional error between 760 m and 3200 m altitude in placebo group
|
Day 1 and 2 at 760 m and at 3200m
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
arterial oxygen saturation
Time Frame: Day 1 and 2 at 760 m and at 3200m
|
Difference in altitude-induced change of arterial oxygen saturation between acetazolamide and placebo group, measured by pulse oxymetry
|
Day 1 and 2 at 760 m and at 3200m
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-00137A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Obstructive Pulmonary Disease (COPD)
-
University College, LondonUniversity of Cambridge; National Institute for Health Research, United Kingdom and other collaboratorsUnknownChronic Obstructive Pulmonary Disease (COPD).United Kingdom
-
Virginia Commonwealth UniversityFisher and Paykel HealthcareCompletedChronic Obstructive Pulmonary Disease(COPD)United States
-
Reham Mohammed ElmorshedyCompletedChronic Obstructive Pulmonary Disease(COPD)Egypt
-
AstraZenecaCompletedChronic Obstructive Pulmonary Disease (COPD).United Kingdom
-
Medtronic BRCUnknownCOPD | COPD Exacerbation
-
Beaumont HospitalAerogenCompletedChronic Obstructive Pulmonary Disease | COPD | COPD Exacerbation | Copd Exacerbation AcuteIreland
-
Chiesi Farmaceutici S.p.A.CompletedModerate to Severe Chronic Obstructive Pulmonary Disease (COPD)Bulgaria, Germany, Hungary, Poland, Russian Federation, United Kingdom
-
Chiesi Farmaceutici S.p.A.CompletedChronic Obstructive Pulmonary Disease (COPD) | COPDUnited Kingdom
-
Elpen Pharmaceutical Co. Inc.Completed
-
Rigshospitalet, DenmarkUnknown
Clinical Trials on ACETAZOLAMIDE oral capsule
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...CompletedAltitude HypoxiaKyrgyzstan
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...CompletedAcute Mountain SicknessKyrgyzstan
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...CompletedAltitude HypoxiaKyrgyzstan
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...CompletedChronic Obstructive Pulmonary DiseaseKyrgyzstan
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...Active, not recruitingAltitude HypoxiaKyrgyzstan
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...CompletedAltitude HypoxiaKyrgyzstan
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...CompletedAltitude HypoxiaKyrgyzstan
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...CompletedChronic Obstructive Pulmonary Disease (COPD)Kyrgyzstan
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...Active, not recruitingAltitude HypoxiaKyrgyzstan
-
University of ZurichNational Center of Cardiology and Internal Medicine named after academician...CompletedChronic Obstructive Pulmonary DiseaseKyrgyzstan