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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

Tracking Information
First Submitted Date  ICMJE May 23, 2017
First Posted Date  ICMJE May 24, 2017
Last Update Posted Date May 14, 2019
Actual Study Start Date  ICMJE May 24, 2017
Actual Primary Completion Date July 24, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 29, 2017)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
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
Change History Complete list of historical versions of study NCT03165890 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 29, 2017)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2017)
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Acetazolamide on Cognition in Patients With Respiratory Disease at Altitude
Official Title  ICMJE Effect of Acetazolamide on Visuomotor Learning Performance in Patients With Chronic Obstructive Pulmonary Disease at Altitude
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Drug: ACETAZOLAMIDE oral capsule
    Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
  • Drug: Placebo oral capsule
    Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
Study Arms  ICMJE
  • 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
    Intervention: Drug: ACETAZOLAMIDE oral capsule
  • 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.
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2019)
78
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2017)
50
Actual Study Completion Date  ICMJE July 24, 2017
Actual Primary Completion Date July 24, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Kyrgyzstan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03165890
Other Study ID Numbers  ICMJE 2017-00137A
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
Investigators  ICMJE
Study Chair: Konrad E Bloch, MD University of Zurich
Study Director: Talant M Sooronbaev, MD National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
PRS Account University of Zurich
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP