Clinical Trial Results:
Urine concentrations of vilanterol after inhaled administration of vilanterol/fluticasone furoate: Defining a urine threshold and decision limit for vilanterol in doping control analysis
Summary
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EudraCT number |
2018-002529-48 |
Trial protocol |
DK |
Global end of trial date |
14 Dec 2020
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Results information
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Results version number |
v1(current) |
This version publication date |
11 Jan 2022
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First version publication date |
11 Jan 2022
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
WADA2018vil
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Center for Aktiv Sundhed, Rigshospitalet
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Sponsor organisation address |
Rigshospitalet afsnit 7641, Blegdamsvej 9, 2100 København Ø, Copenhagen, Denmark,
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Public contact |
CFAS, Center for Aktiv Sundhed, Rigshospitalet, eriksorenhalvardhansen@gmail.com
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Scientific contact |
CFAS, Center for Aktiv Sundhed, Rigshospitalet, eriksorenhalvardhansen@gmail.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Dec 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Dec 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Dec 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To determine urine concenctrations of vilanterol and its metabolites after therapeutic and supratherapeutic use.
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Protection of trial subjects |
The subjects had a bed to rest. No more measures were needed.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Jun 2020
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Denmark: 25
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Worldwide total number of subjects |
25
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EEA total number of subjects |
25
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
25
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||
Pre-assignment
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Screening details |
Eligibility criteria were physically active males or females (at least 5 hours physical activity weekly), aged 18-39 years. 42 individuals were screened and 25 included. 6 individuals dropped out during the study, resulting in 19 individuals completing all 4 trials. | ||||||||||||
Period 1
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Period 1 title |
Trial 1 - 25 µg inhalation
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||
Arms
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Arm title
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Trial 1 - 25 µg | ||||||||||||
Arm description |
Due to the limits of reporting results, this "arm" represents the first trial of the four trials. The study only has 1 arm, which completes four trial periods. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Relvar ElliptaTM, 22/184 µg vilanterol/fluticasone furoate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
The study consisted of four trials. During trials 1 and 3, participants inhaled a single dose (25 µg; Trial 1) or four doses (100 µg; Trial 3). After the single-dose trials (Trial 1 and 3), participants received an inhaler for home administration of the study drug. Trials 2 and 4 were preceded by a repeated dosing regime of once-daily inhalation of 25 µg (7d25 µg; Trial 2) or 100 µg (7d100 µg; Trial 4) for 6 days. Trials were separated by at least a 1-week washout. Home administrations were monitored by staff via online video tools to maximize drug compliance and assess inhalation technique.
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Period 2
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Period 2 title |
Trial 2 - 7d 25 µg
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Is this the baseline period? |
No | ||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||
Blinding implementation details |
Not Blinded
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Arms
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Arm title
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Trial 2 - 7d 25 µg | ||||||||||||
Arm description |
Due to the limits of reporting results, this "arm" represents the second trial of the four trials. The study only has 1 arm, which completes four trial periods. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Relvar ElliptaTM, 22/184 µg vilanterol/fluticasone furoate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
The study consisted of four trials. During trials 1 and 3, participants inhaled a single dose (25 µg; Trial 1) or four doses (100 µg; Trial 3). After the single-dose trials (Trial 1 and 3), participants received an inhaler for home administration of the study drug. Trials 2 and 4 were preceded by a repeated dosing regime of once-daily inhalation of 25 µg (7d25 µg; Trial 2) or 100 µg (7d100 µg; Trial 4) for 6 days. Trials were separated by at least a 1-week washout. Home administrations were monitored by staff via online video tools to maximize drug compliance and assess inhalation technique.
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Period 3
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Period 3 title |
Trial 3 - 100 µg
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Is this the baseline period? |
No | ||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||
Blinding implementation details |
Not blinded
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Arms
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Arm title
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Trial 3 - 100 µg | ||||||||||||
Arm description |
Due to the limits of reporting results, this "arm" represents the third trial of the four trials. The study only has 1 arm, which completes four trial periods. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Relvar ElliptaTM, 22/184 µg vilanterol/fluticasone furoate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
The study consisted of four trials. During trials 1 and 3, participants inhaled a single dose (25 µg; Trial 1) or four doses (100 µg; Trial 3). After the single-dose trials (Trial 1 and 3), participants received an inhaler for home administration of the study drug. Trials 2 and 4 were preceded by a repeated dosing regime of once-daily inhalation of 25 µg (7d25 µg; Trial 2) or 100 µg (7d100 µg; Trial 4) for 6 days. Trials were separated by at least a 1-week washout. Home administrations were monitored by staff via online video tools to maximize drug compliance and assess inhalation technique.
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Period 4
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Period 4 title |
Trial 4 - 7d 100 µg
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Is this the baseline period? |
No | ||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||
Blinding implementation details |
Not blinded
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Arms
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Arm title
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Trial 4 - 7d 100 µg | ||||||||||||
Arm description |
Due to the limits of reporting results, this "arm" represents the fourth trial of the four trials. The study only has 1 arm, which completes four trial periods. | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Relvar ElliptaTM, 22/184 µg vilanterol/fluticasone furoate
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Inhalation powder
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Routes of administration |
Inhalation use
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Dosage and administration details |
The study consisted of four trials. During trials 1 and 3, participants inhaled a single dose (25 µg; Trial 1) or four doses (100 µg; Trial 3). After the single-dose trials (Trial 1 and 3), participants received an inhaler for home administration of the study drug. Trials 2 and 4 were preceded by a repeated dosing regime of once-daily inhalation of 25 µg (7d25 µg; Trial 2) or 100 µg (7d100 µg; Trial 4) for 6 days. Trials were separated by at least a 1-week washout. Home administrations were monitored by staff via online video tools to maximize drug compliance and assess inhalation technique.
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Baseline characteristics reporting groups
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Reporting group title |
Trial 1 - 25 µg inhalation
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Reporting group description |
- | |||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Trial 1 - 25 µg
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Reporting group description |
Due to the limits of reporting results, this "arm" represents the first trial of the four trials. The study only has 1 arm, which completes four trial periods. | ||
Reporting group title |
Trial 2 - 7d 25 µg
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Reporting group description |
Due to the limits of reporting results, this "arm" represents the second trial of the four trials. The study only has 1 arm, which completes four trial periods. | ||
Reporting group title |
Trial 3 - 100 µg
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Reporting group description |
Due to the limits of reporting results, this "arm" represents the third trial of the four trials. The study only has 1 arm, which completes four trial periods. | ||
Reporting group title |
Trial 4 - 7d 100 µg
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Reporting group description |
Due to the limits of reporting results, this "arm" represents the fourth trial of the four trials. The study only has 1 arm, which completes four trial periods. |
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End point title |
Urine values of Vilanterol [1] | ||||||||||||||||||||
End point description |
The mean of maximum urine concentrations (Cmax) of parent vilanterol, with the min-max range, is presented here.
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End point type |
Primary
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End point timeframe |
Urine values was collected -1 to 72 hours after inhalation of vilanterol
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This study presents urine values of vilanterol and its metabolites after inhalation of relvar elipta. Only minor statistical analyses was made in the presentation of those values. |
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
At the beginning of each trial day or by self-reporting.
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Assessment type |
Systematic | ||
Dictionary used for adverse event reporting
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Dictionary name |
Study dictionary | ||
Dictionary version |
1
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Frequency threshold for reporting non-serious adverse events: 5% | |||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: I do not have access to records of non-serious adverse events. This will be typed in later. |
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |