Brief Summary

Introduction: The prevalence of asthma and exercise-induced bronchoconstriction is high in the athletic population. In endurance sport, the prevalence has been reported to be as high as 30-50% compared to the general population prevalence of approximately 5-10% in Western countries. First-line treatment in asthma is reliever medication and inhaled corticosteroids (ICS). Therefore, β2-adrenoceptor agonists and ICS are commonly prescribed drugs to athletes. Although long-acting β2-agonists (LABA) are the most commonly used β2-agonists in asthma management, development of ultra-long acting β2-agonists (U-LABA) as vilanterol may change this. U-LABA has a long duration of action (24 hours) compared with LABA (12 hours). The accumulated number of inhalations per day for elite athletes may thus be reduced when prescribed with U-LABA as compared to LABA. Use of β2-agonists are restricted by the World Anti-Doping Agency (WADA). As of 2018, β2-agonists salbutamol, formoterol and salmeterol are allowed by inhalation in therapeutic doses, whereas other β2-agonists, such as terbutaline and vilanterol still require the athlete to obtain a therapeutic use exemption (TUE). To discriminate therapeutic use from supra-therapeutic misuse, WADA has established urinary thresholds and decision limits based on urine concentrations of salbutamol, salmeterol and formoterol. However, while data on urine concentrations of these three β2-agonists are well-described in studies that simulate sport-specific situations that are applicable for doping control, no such data exist for the novel U-LABA vilanterol. For instance, asthmatic athletes using β2-agonists usually inhale the drug before training or competition as prophylaxis for bronchoconstriction. Thus, studies are needed to investigate the urine concentrations of vilanterol after inhaled administration in set-ups that are applicable to doping control which this study aims to investigate. Method: The study is divided in two phases. The first phase consists of a pharmacokinetic pilot trial (EXP1). Depending on the analytical outcome of the pilot study, the study proceeds into the second phase, which is a larger pharmacokinetic trial (EXP2). Both EXP1 and EXP 2 are open label studies. EXP1: 6 healthy, well trained individuals are recruited to perform two trial days. First trial day consists of inhalation of the study drug in 4 times therapeutic dose followed by an exercise session. Before second trial day subjects inhales 4 times the therapeutic dose at home and on day 7 perform a training session. Urine and blood are collected in the following 72 hours both days. EXP2: 20 healthy, well trained individuals are recruited to perform four trial days in the same way as EXP1. But here both normal use and four times normal dose is investigated.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_2

Timeline

Completed

Started Feb 2019

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.8 years study duration

First Submitted

Initial submission to the registry

November 9, 2018

Completed

4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2018

Completed

3 months until next milestone

Study Start

First participant enrolled

February 8, 2019

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed

Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

November 9, 2018

Last Update Submit

January 26, 2021

Conditions

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

Vilanterol and its metabolites
Urine concentrations of vilanterol and its metabolites (GSK932009 and GW630200) 0-72 hours post drug administration.
72 hours post drug administration
Vilanterol and its metabolites
Blood concentrations of vilanterol and its metabolites (GSK932009 and GW630200) 0-10 hours post drug administration
0-10 hours post drug administration