The Influence of Exercise and Hydration to the Pharmacological Response to Inhaled Terbutalin and Salbutamol in Men

NCT ID: NCT05749523

Last Updated: 2023-03-01

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-09-30

Brief Summary

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To investigate the effects of dehydration and exercise for the urine secretion of beta2-agonists.

Detailed Description

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No studies have examined the influence of factors such as exercise and dehydration on the pharmacokinetic profile of asthmatic drugs (beta2-agonists). Exercise may modify the metabolism and excretion of drugs, and sweat loss during exercise can result in dehydration, both affecting the urine concentration of the drug.

Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Exercise

Exercise vs. non-exercise

Group Type OTHER

Exercise

Intervention Type BEHAVIORAL

Exercise vs non-exercise

Interventions

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Exercise

Exercise vs non-exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* men
* aerobic capacity more than 50ml / min / kg
* more than 5h training pr week

Exclusion Criteria

* smokers
* allergy for the medicine
* chronic diseases
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Vibeke Backer

OTHER

Sponsor Role lead

Responsible Party

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Vibeke Backer

Professor, Dr. Med. Chief Physician

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Vibeke Backer, Professor

Role: PRINCIPAL_INVESTIGATOR

Dept of Respiratory Medicine, Bispebjerg University Hospital

Locations

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Department of Respiratory Medicine, L, Bispebjerg Hospital,

Copenhagen, NV, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2013-000483-29

Identifier Type: -

Identifier Source: org_study_id

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