Urinary Concentration After Salmeterol

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Other: Normal conditions; Other: Heated conditions; Drug: Salmeterol inhalation and urine samples

• Registration Number: NCT06657547
• Lead Sponsor: University of Copenhagen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-24
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29
• Study Start: 2024-11-01
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Normal conditions	Normal conditions	Urine samples collected after various performance tests in normal conditions
Heated conditions	Heated conditions	Urine samples collected after various performance tests in heated conditions
Salmeterol inhalation and urine samples	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.

Primary Outcome Measures

Name	Time	Method
Urine concentration	Through study completion, an average on 1 week	Difference in urine concentration with salmeterol administered before performance tests in different conditions

Trial Locations

Locations (1)

August Krogh Building; 🇩🇰 Copenhagen, Denmark