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Generation of Biological Samples Positive to Salmeterol for Anti-Doping Control

NCT04195867 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-12-12

No results posted yet for this study

Summary

Background:

In terms of doping, there is controversy regarding the beneficial effects of β2-agonists like salmeterol on physical performance. Some studies show improvement with salmeterol administered orally, especially related to pulmonary function and muscle contractibility, while other works do not show such ergogenic effects of salmeterol by inhalation.

Supratherapeutic use of salmeterol is prohibited by the World Anti-Doping Agency, but a maximum allowed urine concentration has not been determined.

Urine concentrations of salmeterol are very low when administered at therapeutic doses, often below the lower limit of quantification. Some studies show that urine concentrations of α-hydroxy-salmeterol (the principal salmeterol metabolite) may be higher than those of the original drug. Thus, α-hydroxy-salmeterol might be a more suitable biomarker for detecting fraudulent use of this drug.

Hypothesis:

Inhaled administration of salmeterol in healthy subjects allows obtaining positive urine samples that will be used to identify analytical strategies for doping detection. Salmeterol concentrations and its metabolites (α-hydroxy-salmeterol and others) can be measured in urine.

Objectives:

Primary objective: To generate urine samples positive to salmeterol in order to be analyzed as control samples by anti-doping laboratories.

Secondary objectives: To identify salmeterol metabolites (α-hydroxy-salmeterol and others) in urine.

Methods:

Phase I, open, non-randomized, uncontrolled clinical trial, with a treatment condition (salmeterol) administered daily by inhalation to 6 subjects during 3 consecutive days.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Salmeterol Xinafoate

Subjects receive a daily inhaled dose of 200 μg (4 inhalations of 50 μg each).

Sponsors & Collaborators

  • Parc de Salut Mar

    lead OTHER

Principal Investigators

  • Julián A Mateus Rodríguez, MD · IMIM (Hospital del Mar Medical Research Institute)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2019-01-08
Completion
2019-01-08

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04195867 on ClinicalTrials.gov