Chronic Obstructive Pulmonary Disease (COPD)Phase 4NCT03165890
Effect of Acetazolamide on Cognition in Patients With Respiratory Disease at Altitude
A Phase 4 study testing ACETAZOLAMIDE oral capsule in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Zurich at 1 site in Kyrgyzstan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- ACETAZOLAMIDE oral capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 24 May 2017to 24 Jul 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site
National Center of Cardiology and Internal Medicine
Bishkek, 720040
About this study
Official title: Effect of Acetazolamide on Visuomotor Learning Performance in Patients With Chronic Obstructive Pulmonary Disease at Altitude
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.
Read the 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.
- Being tested
- ACETAZOLAMIDE oral capsule, Placebo oral capsule
- Keywords
- cognition, visuomotor learning, airway disease, altitude, prevention, acetazolamide
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACETAZOLAMIDE oral capsuleDrug
Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
Placebo oral capsuleDrug
Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
| Study group | Role | What they receive |
|---|---|---|
| ACETAZOLAMIDE oral capsule | Active comparator | 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 Receives: Drug: ACETAZOLAMIDE oral capsule |
| PLACEBO oral capsule | Placebo comparator | 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. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
visuomotor learning performance, drug effect
Difference in altitude-induced change in directional error between acetazolamide and placebo group, measured by the motor task manager
Measured: Day 2 at 760m and 3200m
visuomotor learning performance, altitude effect
Difference in directional error between 760 m and 3200 m altitude in placebo group
Measured: Day 1 and 2 at 760 m and at 3200m
Secondary outcomes (1)
arterial oxygen saturation
Difference in altitude-induced change of arterial oxygen saturation between acetazolamide and placebo group, measured by pulse oxymetry
Measured: Day 1 and 2 at 760 m and at 3200m
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start24 May 2017
- Primary completion24 Jul 2017
- Study completion24 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Responsible party
- Sponsor
- Investigators
- Konrad E Bloch, MD, Study chair, University of ZurichTalant M Sooronbaev, MD, Study director, National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165890
- Sponsor's protocol ID
- 2017-00137A
- Other IDs
- 2017
- Status last verified
- May 2019
- First submitted
- 23 May 2017
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Scheiwiller PM, Furian M, Buergin A, Mayer LC, Schneider SR, Mademilov M, Lichtblau M, Muralt L, Sheraliev U, Sooronbaev TM, Ulrich S, Bloch KE. Visuomotor performance at high altitude in COPD patients. Randomized placebo-controlled trial of acetazolamide. Front Physiol. 2022 Sep 8;13:980755. doi: 10.3389/fphys.2022.980755. eCollection 2022.
PubMed 36160864
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acetazolamide on Visuomotor Learning Performance in Patients With Chronic Obstructive Pulmonary Disease at Altitude
- ClinicalTrials.gov ID
- NCT03165890
- Acronym / sponsor ID
- 2017-00137A
- Keywords
- cognition, visuomotor learning, airway disease, altitude, prevention, acetazolamide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Study start
- 24 May 2017 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACETAZOLAMIDE oral capsule | Active comparator | Drug: ACETAZOLAMIDE oral capsuleAcetazolamide 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 |
| PLACEBO oral capsule | Placebo comparator | Drug: Placebo oral capsulePlacebo (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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACETAZOLAMIDE oral capsuleAdministration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m | Drug | ACETAZOLAMIDE oral capsule |
| Placebo oral capsuleAdministration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m | Drug | PLACEBO oral capsule |
Primary outcome
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
1 secondary outcome
arterial oxygen saturation
Time frame: Day 1 and 2 at 760 m and at 3200m
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Derived from this study: PubMed 36160864Scheiwiller PM, Furian M, Buergin A, Mayer LC, Schneider SR, Mademilov M, Lichtblau M, Muralt L, Sheraliev U, Sooronbaev TM, Ulrich S, Bloch KE. Visuomotor performance at high altitude in COPD patients. Randomized placebo-controlled trial of acetazolamide. Front Physiol. 2022 Sep 8;13:980755. doi: 10.3389/fphys.2022.980755. eCollection 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konrad E Bloch, MD study chair
University of Zurich
Talant M Sooronbaev, MD study director
National Center of Cardiology and Internal Medicine, Bishkek, Kyrgyzstan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ACETAZOLAMIDE oral capsule in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of Zurich at 1 site in Kyrgyzstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kyrgyzstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visuomotor learning performance, drug effect (time frame: Day 2 at 760m and 3200m). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03165890, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.