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Carbonic Anhydrase Inhibitor

AZ, MZ, and the Pulmonary System Response to Hypoxia

Phase 4

Waitlist Available

Led By Glen E Foster, Ph.D.

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 60 minutes

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Pivotal Trial

Drug Has Already Been Approved

Summary

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.

Eligible Conditions

Pulmonary Hypertension
Altitude Sickness

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 60 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 60 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 60 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pulmonary artery pressure

Continuous Positive Airway Pressure

Secondary study objectives

Change in cerebral blood velocity

Other study objectives

Change in cardiac output

Change in pulmonary venous blood velocity

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: MethazolamideExperimental Treatment1 Intervention

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 II: AcetazolamideExperimental Treatment1 Intervention

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 III: PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetazolamide

FDA approved

Methazolamide

FDA approved