Urinary Concentration After Salmeterol

April 7, 2025 updated by: Morten Hostrup, PhD, University of Copenhagen

Urinary Concentration After Salmeterol in Well-trained Men and Females

The purpose of the project is to investigate urine concentration after inhalation of salmeterol. This will be examined following acute physical activity under both normal conditions and heated conditions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • August Krogh Building
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inclusion Criteria:
  • Age 18-40
  • Physically active >5 hours a week
  • Maximum oxygen uptake classified as high or very high

Exclusion Criteria:

  • Active smoker currently or within the past 5 years
  • Regular intake of medication deemed by the responsible study physician to affect the test parameters (hormonal contraception is accepted for women)
  • Chronic or acute illness deemed by the responsible study physician to affect the test parameters
  • Deviation from the study protocol
  • Lean mass index >21 kg/m²
  • Pregnancy
  • Smoker
  • Blood donation during the past 3 months

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal conditions
Urine samples collected after various performance tests in normal conditions
Other: Normal conditions
Participants are administered salmeterol, after which they perform various performance tests in normal conditions. Following the administration of salmeterol, urine samples are collected over the next 24 hours at intervals of 0.5, 1, 2, 4, 8, and 24 hours after administration.
Experimental: Heated conditions
Urine samples collected after various performance tests in heated conditions
Other: Heated conditions
Participants are administered salmeterol, after which they perform various performance tests in heated conditions. Following the administration of salmeterol, urine samples are collected over the next 24 hours at intervals of 0.5, 1, 2, 4, 8, and 24 hours after administration.
Other: Salmeterol inhalation and urine samples
Participants are administered daily salmeterol inhalation from an MDI device and are required to collect spot urine samples at home.
Drug: Salmeterol inhalation and urine samples
After the experimental day under normal conditions, all participants are administered 200 µg of salmeterol daily (8 puffs from the MDI device) during a 6-day intervention period. Two hours after inhalation, the participants collect spot urine samples at home

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine concentration
Time Frame: Through study completion, an average on 1 week
Difference in urine concentration with salmeterol administered before performance tests in different conditions
Through study completion, an average on 1 week

Collaborators and Investigators

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

Sponsor

University of Copenhagen

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 (Actual)

October 31, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

October 23, 2024

First Posted (Actual)

October 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 7, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SALM_urine

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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