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Recruiting

NCT Number: NCT06657547

Urinary Concentration After Salmeterol

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.

Recruiting

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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

August Krogh Building

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Morten Hostrup, PhD

CONTACT

[email protected]

+4535321595

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal conditions

Other

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.

Heated conditions

Other

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.

Salmeterol inhalation and urine samples

Drug

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

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Morten Hostrup, PhD

CONTACT

[email protected]

+4535321595

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

Urinary Concentration After Salmeterol in Well-trained Men and Females

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 24, 2024
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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