Urine concentrations of vilanterol after inhaled administration of vilanterol/fluticasone furoate: Defining a urine threshold and decision limit for vilanterol in doping control analysis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002529-48-DK

Enrollment

Registered

2018-07-03

Start date

2018-09-12

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pharmacokinetics of vilanterol in relation to doping analysis MedDRA version: 21.0 Level: LLT Classification code 10053349 Term: Pharmacokinetic study System Organ Class: 100000004848

Interventions

Trade Name: Relvar Ellipta 184/22 Product Name: Relvar Ellipta 22/184 Pharmaceutical Form: INN or Proposed INN: FLUTICASONE FUROATE CAS Number: 397864-44-7 Concentration unit: µg microgram(s) Concent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Included subjects are: - Healthy - 18 - 39 years - Able to use an inhalation device - Active at least 5 hours a week - VO2-max classified as high or very high measured during incremental test to exhaustion during the screening visit - Male or non-pregnant female - Females of childbearing potential has to use one or more methods for contraception in order to be included: vasectomised partner, bilateral tubal occlusion, sexual abstinence, intrauterine device or hormonal contraception. - Females who are considered to have no childbearing potential are: bilateral tubal ligation, bilateral oophorectomy, complete hysterectomy, postmenopausal defined as 12 months with no menses without an alternative Medical cause. - Non-smokers - No daily use of prescribed medicine Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Diagnosis of Heart, pulmonary (including asthma GINA 2-5), intestinal and renal diseases - Allergy towards active drug or any substances used in the drug - Non-compliance with the protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine urine concenctrations of vilanterol and its metabolites after therapeutic and supratherapeutic use. ;Secondary Objective: To determine urine concentrations of vilanterol and its metabolites after 7 days of therapeutic and supratherapeutic use. ;Primary end point(s): Urineconcentration of vilanterol and its metabolites (GSK932009 and GW630200) after inhalation of Relvar. ;Timepoint(s) of evaluation of this end point: Endpoints will be evaluated last part of 2018	—

Measure

Time frame

Main Objective: To determine urine concenctrations of vilanterol and its metabolites after therapeutic and supratherapeutic use. ;Secondary Objective: To determine urine concentrations of vilanterol and its metabolites after 7 days of therapeutic and supratherapeutic use. ;Primary end point(s): Urineconcentration of vilanterol and its metabolites (GSK932009 and GW630200) after inhalation of Relvar. ;Timepoint(s) of evaluation of this end point: Endpoints will be evaluated last part of 2018

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Denmark

Contacts

Public ContactCFAS

Center for Aktiv Sundhed, Rigshospitalet

eriksorenhalvardhansen@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026