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

February 27, 2023 updated by: Vibeke Backer
To investigate the effects of dehydration and exercise for the urine secretion of beta2-agonists.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • NV
      • Copenhagen, NV, Denmark, 2400
        • Department of Respiratory Medicine, L, Bispebjerg Hospital,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Exercise
Exercise vs. non-exercise
Behavioral: Exercise
Exercise vs non-exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine concentration of salbutamol and terbutalin
Time Frame: 7 days
Urine concentration of salbutamol and terbutalin
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vibeke Backer

Investigators

  • Principal Investigator: Vibeke Backer, Professor, Dept of Respiratory Medicine, Bispebjerg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

February 27, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2013-000483-29

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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