Pharmacokinetics of Procaterol in Elite Athletes (Procat)

February 27, 2023 updated by: Vibeke Backer, Bispebjerg Hospital

Procaterol in Elite Athletes - a PK Study

The purpose of the study is to find blood and urine concentrations of procaterol administrated either by inhalation or by tablets in asthmatic and non-asthmatics males. We hypotheis that the concentrations of procaterol in the blood and serum is higher after tablet intake versus inhalation.

Study Overview

Status

Completed

Conditions

Detailed Description

Doping study

Study Type

Observational

Enrollment (Actual)

20

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
      • Copenhagen, Denmark, DK-2400
        • 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 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Asthmatic and healthy volunteers

Description

Inclusion Criteria:

  • Doctor diagnosed asthma for the asthmatic group
  • GINA 1-3 for the asthmatic group
  • Use of beta2-agonist for at least 12 months for the asthmatic group
  • age 18-45
  • males
  • informed consent

Exclusion Criteria:

  • smoker or former smoker
  • airway infection to weeks prior to the study or during the study
  • other chronic diseaes than asthma and allergy
  • Use of beta2-agonist 6 days prior to the study
  • Allergy to the study medicine

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

Cohorts and Interventions

Group / Cohort
Asthma
With positive asthma test
Healthy
With no signs of asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urine concentration of drug 0-24 h
Time Frame: 7 days
In healthy subjects to investigate drug farmakokenetic
7 days
serum concentration of drug 0-24 h
Time Frame: 7 days
In healthy subjects to investigate drug farmakokenetic
7 days

Collaborators and Investigators

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

Sponsor

Bispebjerg Hospital

Investigators

  • Principal Investigator: Vibeke Backer, MD, Bispebjerg 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

August 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

November 5, 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

  • Procaterol

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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