Urinary Concentration After Salmeterol
ConditionHealthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversity of Copenhagen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-40
Physically active >5 hours a week
Maximum oxygen uptake classified as high or very high
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
Normal conditions
Other interventionParticipants 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 interventionParticipants 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
DrugAfter 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
Treatment groups
24 Participants
are divided into 3 treatment groupsGroup A: Normal conditionsActive comparator 1 intervention
Group B: Heated conditionsExperimental treatment 1 intervention
Group C: Salmeterol inhalation and urine samplesOther 1 intervention
Trial outcomes
Primary outcomes
1
Urine concentration
Difference in urine concentration with salmeterol administered before performance tests in different conditions
Time frame
Through study completion, an average on 1 weekSponsors and contacts
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Source ClinicalTrials.gov