Urinary Concentration After Salmeterol

NCT06657547 | Recruiting

• 1 other identifier: SALM_urine
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Urinary concentration; Beta2-adrenergic stimulation

Outcome Measures

Primary Outcomes (1)

• Urine concentration

  Difference in urine concentration with salmeterol administered before performance tests in different conditions

  Through study completion, an average on 1 week

Study Arms (3)

Normal conditions

ACTIVE COMPARATOR

Urine samples collected after various performance tests in normal conditions

Other: Normal conditions

Heated conditions

EXPERIMENTAL

Urine samples collected after various performance tests in heated conditions

Other: Heated conditions

Salmeterol inhalation and urine samples

OTHER

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

Interventions

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.

Normal conditions

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.

Heated conditions

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

Salmeterol inhalation and urine samples

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

August Krogh Building

Copenhagen, 2100, Denmark

RECRUITING

Central Study Contacts

Morten Hostrup, PhD

CONTACT

+4535321595; mhostrup@nexs.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

DK (1)