Effect of Acetazolamide and Methazolamide on Hypoxic Exercise Performance

NCT05575180 | Completed Phase 4

• 1 other identifier: 43720
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

High Altitude Effects

Keywords

exercise

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Expired Minute Ventilation

  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 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

Study Arms (3)

Methazolamide

EXPERIMENTAL

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

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

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

Drug: Placebo

Interventions

Acetazolamide 250Mg Tab DRUG

Oral acetazolamide

Acetazolamide

Methazolamide Pill DRUG

Oral Methazolamide

Methazolamide

Placebo DRUG

Oral placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Waterloo: lead
• Wilderness Medical Society: collaborator

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L3G1, Canada

Location

MeSH Terms

Conditions

Altitude Sickness; Motor Activity

Interventions

Acetazolamide; Methazolamide

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Behavior

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: October 12, 2022
• Study Start: August 11, 2023
• Primary Completion: February 22, 2024
• Study Completion: February 22, 2024
• Last Updated: March 12, 2024

Record last verified: 2023-09

Locations

CA (1)