Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Acetazolamide on Cognition in Patients With Respiratory Disease at Altitude

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03165890
Recruitment Status : Completed
First Posted : May 24, 2017
Last Update Posted : May 14, 2019
Sponsor:
Collaborator:
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Randomized, placebo controlled trial evaluating the effect of acetazolamide on cognition in lowlanders with chronic obstructive pulmonary disease travelling from 760 m to 3200 m.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: ACETAZOLAMIDE oral capsule Drug: Placebo oral capsule Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Acetazolamide on Visuomotor Learning Performance in Patients With Chronic Obstructive Pulmonary Disease at Altitude
Actual Study Start Date : May 24, 2017
Actual Primary Completion Date : July 24, 2017
Actual Study Completion Date : July 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165890


Locations
Layout table for location information
Kyrgyzstan
National Center of Cardiology and Internal Medicine
Bishkek, Kyrgyzstan, 720040
Sponsors and Collaborators
University of Zurich
National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Investigators
Layout table for investigator information
Study Chair: Konrad E Bloch, MD University of Zurich
Study Director: Talant M Sooronbaev, MD National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan

Layout table for additonal information
Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT03165890     History of Changes
Other Study ID Numbers: 2017-00137A
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: May 14, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
cognition
visuomotor learning
airway disease
altitude
prevention
acetazolamide
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Acetazolamide
Anticonvulsants
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs