High Altitude EffectsPhase 4NCT05575180
Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance
A Phase 4 study testing Acetazolamide 250Mg Tab and Methazolamide Pill in people with High Altitude Effects, run by University of Waterloo at 1 site in Canada.
Trial summary
A single-centered randomized doubled blinded placebo-controlled cross-over trial comparing two the effect of two carbonic anhydrase inhibitors on exercise performance in acute hypoxia. Participants will be young (under 40 years of age), healthy males and females who are regularly physically active. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- High Altitude Effects
- What is being tested?
- Acetazolamide 250Mg Tab and Methazolamide Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 11 Aug 2023to 22 Feb 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Consent provided
- Between ages of 18-40 years old
- In good general health as evidences by medical history
- Perform at least 150 mins of aerobic exercise per week, and engage in physical activity >2 days a week
- Completed in an endurance event in the last 12 months
- Ability to take oral medication, and be willing to adhere to the drug regimen
- Be willing to have blood samples taken
Who cannot join
- Weigh 49kg or less, or are Obese (BMI >30 kg/m2)
- Presence of chronic health condition (s), being investigated and/or taking prescription medications for the following disorders:
- Cardiovascular - e.g., hypertension
- Metabolic - e.g., type 1 or 2 diabetes
- Respiratory - e.g., chronic obstructive pulmonary disease, asthma
- Digestive - e.g., ulcerative colitis
Show all 15Show fewer
- Arthritis
- Cancer
- Presence of any disorder or condition listed in the health screening questionnaire (see section 12.1)
- Current use of Lonafarnib, Methenamine, Topamax, or steroids/corticosteroids
- Known allergic reactions/hypersensitivity to carbonic anhydrase inhibitors or sulfonamides
- Presence of bleeding or clotting disorders
- Current smoker or cannabis user
- Pregnant, suspect to be pregnant, currently planning a pregnancy, or nursing
- Any condition or diagnosis, that could in the opinion of the Principal Investigator or delegate interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study results, or put the participant at risk
Trial locations and contacts
1 site in 1 country.
About this study
A single-centered randomized doubled blinded placebo-controlled cross-over trial comparing two the effect of two carbonic anhydrase inhibitors on exercise performance in acute hypoxia. Participants will be young (under 40 years of age), healthy males and females who are regularly physically active.
- Conditions
- High Altitude Effects
- Being tested
- Acetazolamide 250Mg Tab, Methazolamide Pill, Placebo
- Keywords
- exercise
- Medical subject headings
- Altitude Sickness, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetazolamide 250Mg TabDrug
Oral acetazolamide
Methazolamide PillDrug
Oral Methazolamide
PlaceboDrug
Oral placebo
| Study group | Role | What they receive |
|---|---|---|
| Methazolamide | Experimental | Drug: Methazolamide Dose: 100 mg b.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral Receives: Drug: Methazolamide Pill |
| Acetazolamide | Active comparator | Drug: Acetazolamide Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral Receives: Drug: Acetazolamide 250Mg Tab |
| Placebo | Placebo comparator | Drug: Placebo (microcrystalline cellulose) Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete a 5 km time trial after each experimental day (Days 3-5)
Primary endpoint is the time to complete a 5 km exercise task in the three arms of the trial (acetazolamide, methazolamide, placebo)
Measured: The time to complete the 5 km time trial is measured after each time trial. The investigators will be blinded until all participants have completed each trial
Secondary outcomes (2)
Expired Minute Ventilation
The secondary endpoint expired minute ventilation will be measured using a flow meter (pneumotach) which measure flow and allows for the calculation of ventilation. The value is expressed in liters per min and measured continuously
Measured: The average minute ventilation for each time trial km (1-5) for each arm will be determined. The investigators will be blinded until all participants have completed each trial
Oxyhemoglobin saturation
The secondary endpoint oxyhemoglobin saturation will be measured using a pulse oximeter which measure the fraction of hemoglobin bound to oxygen. The value is expressed as a percent and measured continuously
Measured: The average oxyhemoglobin saturation for each time trial km (1-5) for each arm will be determined. The investigators will be blinded until all participants have completed each trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start11 Aug 2023
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Altitude EffectsStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Waterloo
- Sponsor type
- University, hospital or other
- Collaborators
- Wilderness Medical Society
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05575180
- Sponsor's protocol ID
- 43720
- Status last verified
- Sep 2023
- First submitted
- 8 Sep 2022
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance
- ClinicalTrials.gov ID
- NCT05575180
- Acronym / sponsor ID
- 43720
- Conditions
- High Altitude Effects
- Keywords
- exercise
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of WaterlooUniversity, hospital or other
- Collaborators
- Wilderness Medical Society
- Study start
- 11 Aug 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 12 Oct 2022 (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.
A single-centered randomized doubled blinded placebo-controlled cross-over trial comparing two the effect of two carbonic anhydrase inhibitors on exercise performance in acute hypoxia. Participants will be young (under 40 years of age), healthy males and females who are regularly physically active.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Methazolamide | Experimental | Drug: Methazolamide PillDrug: Methazolamide Dose: 100 mg b.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral |
| Acetazolamide | Active comparator | Drug: Acetazolamide 250Mg TabDrug: Acetazolamide Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral |
| Placebo | Placebo comparator | Drug: PlaceboDrug: Placebo (microcrystalline cellulose) Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Consent provided
- Between ages of 18-40 years old
- In good general health as evidences by medical history
- Perform at least 150 mins of aerobic exercise per week, and engage in physical activity >2 days a week
- Completed in an endurance event in the last 12 months
Key exclusion criteria (15 listed)
- Weigh 49kg or less, or are Obese (BMI >30 kg/m2)
- Presence of chronic health condition (s), being investigated and/or taking prescription medications for the following disorders:
- Presence of any disorder or condition listed in the health screening questionnaire (see section 12.1)
- Current use of Lonafarnib, Methenamine, Topamax, or steroids/corticosteroids
- Known allergic reactions/hypersensitivity to carbonic anhydrase inhibitors or 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 250Mg TabOral acetazolamide | Drug | Acetazolamide |
| Methazolamide PillOral Methazolamide | Drug | Methazolamide |
| PlaceboOral placebo | Drug | Placebo |
Primary outcome
Time to complete a 5 km time trial after each experimental day (Days 3-5)
Time frame: The time to complete the 5 km time trial is measured after each time trial. The investigators will be blinded until all participants have completed each trial
Primary endpoint is the time to complete a 5 km exercise task in the three arms of the trial (acetazolamide, methazolamide, placebo)
2 secondary outcomes
Expired Minute Ventilation
Time frame: The average minute ventilation for each time trial km (1-5) for each arm will be determined. The investigators will be blinded until all participants have completed each trial
Oxyhemoglobin saturation
Time frame: The average oxyhemoglobin saturation for each time trial km (1-5) for each arm will be determined. The investigators will be blinded until all participants have completed each trial
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 12 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 250Mg Tab and Methazolamide Pill in people with High Altitude Effects, run by University of Waterloo at 1 site in Canada.
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 7 inclusion and 15 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 12 Mar 2024. 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 Canada. 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?
Time to complete a 5 km time trial after each experimental day (Days 3-5) (time frame: The time to complete the 5 km time trial is measured after each time trial. The investigators will be blinded until all participants have completed each trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.