AZ, MZ, and the Pulmonary System Response to Hypoxia

NCT ID: NCT02760121

Last Updated: 2016-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-08-31

Brief Summary

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The purpose of this proposal is to compare the physiological effects of acetazolamide (AZ) and methazolamide (MZ) on the control of breathing and hypoxic pulmonary vasoconstriction. The first objective is to assess the effects of AZ and MZ on the control of breathing in normoxia and hypoxia. To achieve this the ventilatory interaction between oxygen and carbon dioxide will be measured and effects compared between placebo, AZ, and MZ conditions. In addition, the isocapnic and poikilocapnic hypoxic ventilatory response and hypercapnic ventilatory response will be measured with each drug. The second objective is to assess the effects of AZ and MZ on the control of the pulmonary vasculature during hypoxia. Pulmonary pressure and cardiac output will be measured during 60 minutes of poikilocapnic hypoxia.

Detailed Description

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Conditions

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Altitude Sickness Hypertension, Pulmonary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Acetazolamide

Participants will be dosed 250mg Acetazolamide (p.o.) three times per day for two days prior to and a single dose on the day of study.

Group Type EXPERIMENTAL

Acetazolamide

Intervention Type DRUG

Methazolamide

Participants will be dosed 100mg Methazolamide (p.o.) twice daily separated by a placebo for two days prior to and a single dose on the day of study. The placebo dose is provided to match the dosing schedule between conditions.

Group Type EXPERIMENTAL

Methazolamide

Intervention Type DRUG

Placebo

Participants will take (p.o.) placebo pills three times per day for two days prior to and a single dose on the day of study.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Acetazolamide

Intervention Type DRUG

Methazolamide

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18-40 years of age
* regularly physically active
* male

Exclusion Criteria

* ex-smokers
* pulmonary function \<80% of predicted
* contraindications to carbonic anhydrase inhibitors (eg. severe or absolute glaucoma, adrenocortical insufficiency, hepatic insufficiency, renal insufficiency, sulfa allergy or an electrolyte imbalance such as hyperchloremic acidosis)
* Obese (BMI\>30Kg/m2)
* diuretic medication use
* blood thinner use
* anti-platelet drug use.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glen E Foster, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of British Columbia

Kelowna, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H16-00028

Identifier Type: -

Identifier Source: org_study_id

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