Urinary Concentration After Salmeterol

University of Copenhagen

Status: Enrolling

Conditions: Healthy

Treatments: Other: Normal conditions; Drug: Salmeterol inhalation and urine samples; Other: Heated conditions

Study type: Interventional

Funder types: Other

Identifiers

NCT06657547

SALM_urine

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Normal conditions

Active Comparator group

Description:

Urine samples collected after various performance tests in normal conditions

Treatment:

Other: Normal conditions

Heated conditions

Experimental group

Description:

Urine samples collected after various performance tests in heated conditions

Treatment:

Other: Heated conditions

Salmeterol inhalation and urine samples

Other group

Description:

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

Treatment:

Drug: Salmeterol inhalation and urine samples