Urinary Concentration After Salmeterol

NCT ID: NCT06657547

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Normal conditions

Urine samples collected after various performance tests in normal conditions

Group Type ACTIVE_COMPARATOR

Normal conditions

Intervention Type 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

Urine samples collected after various performance tests in heated conditions

Group Type EXPERIMENTAL

Heated conditions

Intervention Type 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

Participants are administered daily salmeterol inhalation from an MDI device and are required to collect spot urine samples at home.

Group Type OTHER

Salmeterol inhalation and urine samples

Intervention Type 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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Morten Hostrup, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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August Krogh Building

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Morten Hostrup, PhD

Role: CONTACT

+4535321595

Facility Contacts

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Morten Hostrup, PhD

Role: primary

+4535321595

Other Identifiers

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SALM_urine

Identifier Type: -

Identifier Source: org_study_id

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