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

December 10, 2019 updated by: Parc de Salut Mar

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Barcelona, Spain, 08003
        • IMIM (Hospital del Mar Medical Research Institute)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Male volunteers aged between 18 and 45 years.
  • Able to understand and accept the trial procedures and able to sign an informed consent.
  • History and physical examination that demonstrate not presenting organic or psychiatric disorders.
  • ECG, blood and urine tests performed at screening should be within normal limits. Minor or punctual variations of these limits of normality are admitted if, in the opinion of the Principal Investigator, they have no clinical significance, do not pose a risk to the subject and do not interfere with the evaluation of the product in study. These variations and their non-relevance will be justified in writing specifically.
  • Body mass index (weight/size^2) between 19 and 26 kg/m2, and weight between 50 and 90 kg. Subjects with BMI >27 kg/m2 may be included at the discretion of the Principal Investigator.

Exclusion Criteria:

  • Failure to meet the inclusion criteria.
  • History of allergy, idiosyncrasy, hypersensitivity or adverse reactions to the active substance or any of the excipients. History of serious adverse reactions to other medications.
  • Subjects with contraindications to treatment with the study drug (according to Summary of Product Characteristics).
  • Background or clinical evidence of psychiatric disorders, alcoholism, regular consumption of psychoactive drugs, drug abuse or addiction to other substances (except for nicotine). Smokers of more than 5 cigarettes/day will be excluded.
  • Having participated in another clinical trial with medication in the three months prior to the start of the study.
  • Having donated blood during the month prior to the start of the study.
  • Having suffered an organic disease or major surgery in the three months prior to the start of the study.
  • Background or clinical evidence of cardiovascular, respiratory (especially asthma or Chronic Obstructive Pulmonary Disease), renal, hepatic, endocrine, gastrointestinal, hematological, neurological, dermatological or other acute or chronic diseases that, in the opinion of the Principal Investigator or the collaborators designated by him, may pose a risk to the subjects, may interfere with the objectives of the study or may alter the pharmacokinetics of the drug.
  • Have taken medication regularly in the month prior to the study sessions, with the exception of vitamins, herbal remedies or dietary supplements that, in the opinion of the Principal Investigator or the collaborators designated by him, do not pose a risk to the subjects and do not interfere with the objectives of the study. Treatment with single doses of symptomatic medication in the week prior to the study sessions will not be exclusive if it is assumed that medication has been completely eliminated on the day of the experimental session.
  • Consumption of more than 15 g of alcohol per day.
  • Consumers of more than 3 coffees, teas, cola drinks and/or other stimulant drinks (xanthines) per day in the month prior to the start of the study.
  • Being unable to understand the nature of the trial and the procedures requested to follow.
  • Positive serology for hepatitis B, C or HIV.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Salmeterol
Subjects receive a 3-day treatment and collect urine from 2 days before first administration to 24 hours post-administration.
Subjects receive a daily inhaled dose of 200 μg (4 inhalations of 50 μg each).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in urine concentration of salmeterol
Time Frame: From 0 hours after first administration to 48 hours after third administration
Variation of the concentration of salmeterol in urine
From 0 hours after first administration to 48 hours after third administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in urine concentration of α-hydroxy-salmeterol
Time Frame: From 0 hours after first administration to 48 hours after third administration
Variation of the concentration of α-hydroxy-salmeterol in urine
From 0 hours after first administration to 48 hours after third administration
Changes in urine concentrations of other salmeterol metabolites
Time Frame: From 0 hours after first administration to 48 hours after third administration
Variation of the concentration of other salmeterol metabolites in urine
From 0 hours after first administration to 48 hours after third administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2018

Primary Completion (Actual)

January 8, 2019

Study Completion (Actual)

January 8, 2019

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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