Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance

Conditions
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High Altitude Effects

Intervention / Treatment
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* Drug: Acetazolamide 250Mg Tab
* Drug: Methazolamide Pill
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methazolamide<br>Drug: Methazolamide Dose: 100 mg b.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral | Drug: Methazolamide Pill<br>* Oral Methazolamide<br>|
| Active Comparator: Acetazolamide<br>Drug: Acetazolamide Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral | Drug: Acetazolamide 250Mg Tab<br>* Oral acetazolamide<br>|
| Placebo Comparator: Placebo<br>Drug: Placebo (microcrystalline cellulose) Dose: 250 mg t.i.d Duration: 2 days prior to testing + 1 hr prior to testing start Form: Oral | Drug: Placebo<br>* Oral placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise