PharmacokineticsPhase 2NCT03739294
Urine Concentrations of Vilanterol After Inhaled Administration of Vilanterol/Fluticasone Furoate
A Phase 2 study testing Fluticasone Furoate/ Vilanterol Trifenatate in people with Pharmacokinetics, run by Bispebjerg Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics
- What is being tested?
- Fluticasone Furoate/ Vilanterol Trifenatate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 8 Feb 2019to 14 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Age between 18 and 39 years, both included at time of screening
- Ability to correctly use the inhaler device
- Active at least 5 h pr. week (defined as endurance exercise)
- VO2-max classified as high or very high (table 1)(Astrand, 1960) measured during an incremental test to exhaustion at the screening visit
- Male or non-pregnant female
Show all 19Show fewer
- Females of childbearing potential has to use one or more of the following highly effective methods for contraception in order to be included:
- Vasectomized partner
- Bilateral tubal occlusion
- Sexual abstinence
- Intrauterine device
- 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 medication
Who cannot join
- Diagnosis of heart, pulmonary (including asthma in Global initiative for asthma (GINA) 2-5), intestinal and renal diseases
- Allergy towards the active drug or any substances used in the drug
- Non-compliance with the protocol
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Respiratory research unit, Bispebjerg University Hospital
Copenhagen, 2400
About this study
Official title: Urine Concentrations of Vilanterol After Inhaled Administration of Vilanterol/Fluticasone Furoate: Defining a Urine Threshold and Decision Limit for Vilanterol in Doping Control Analysis
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.
Read more
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.
Read the detailed description
OBJECTIVES The main objective of the present study is to investigate urine concentrations of vilanterol and its metabolites (GSK932009 and GW630200) after single dose inhalation of Relvar® (22/184 mcg VI/FF) at therapeutic and supratherapeutic doses. A secondary objective is to investigate whether vilanterol and its metabolites (GSK932009 and GW630200) are present at higher concentrations in urine after seven days of daily inhalation of Relvar® at therapeutic and supratherapeutic doses.
Applicability The results from the study will help establish a urine threshold and decision limit for vilanterol on the WADA list of prohibited substances, thus lessening the administrative burdens associated with TUEs.
Study drug Study treatment in this study is refers to either therapeutic dosage of 22/184 micrograms of vilanterol/fluticasone furoate or four times therapeutic dosage of vilanterol/fluticasone furoate (88/736 micrograms, 4 puffs).
METHODS Study design 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).
Progression from the pilot phase (EXP1) of the study to the second phase (EXP2) of the study depends on a successful pilot phase (EXP1). Success will be concluded provided the pilot phase generates adequate urine concentration data for vilanterol and/or its metabolites (GSK932009, GW630200) with values above the assay limits of quantitation for at least 8 hours post dose. The pilot phase urine concentration data, together with plasma concentration data, will also be used to estimate the urinary concentrations of vilanterol and/or its metabolites at therapeutic and supratherapeutic under various conditions. These estimates will be used to determine whether progression to the second phase of the study is feasible and has a high probability of success in achieving its objectives.
Type of study The study is an open-label study. The study is classified as a Phase II study investigating pharmacokinetics Screening In EXP1 and EXP2, subjects are examined by a medical doctor and electrocardiography (ECG) is performed. Furthermore, subjects' lung function is measured with a spirometer and maximal oxygen consumption (VO2max) and performance are determined during an incremental bike ergometer test to exhaustion. Prior to the test, subjects warm up for 15 min. Subjects are told to keep a cadence of 80-100 rpm during the test. During the warm-up and incremental test, gas exchange is measured breath-by-breath.
After the VO2max-test, inhaler technique is practiced with a demonstrator device.
Pharmacokinetic trials
In EXP1, subjects meet at the laboratory for two trials:
Trial A1: Supra-therapeutic inhalation of Relvar® 22/184 (4 puffs) once Trial A2: Supra-therapeutic inhalation of Relvar® 22/184 (4 puffs) daily for 7 days
In EXP2, subjects meet at the laboratory for four trials:
Trial A1: Supra-therapeutic inhalation of Relvar® 22/184 (4 puffs) once Trial A2: Supra-therapeutic inhalation of Relvar® 22/184 (4 puffs) daily for 7 days Trial B1: Therapeutic inhalation of Relvar® 22/184 (1 puff) once Trial B2: Therapeutic inhalation of Relvar® 22/184 (1 puff) daily for 7 days
During each of the trials, subjects meet in the morning after an overnight fast. A urine sample is collected and subjects ingest a standardized meal and drink. One hour after the meal, study drug is administered during supervision and subjects start performing 60 min of exercise on a bike ergometer. Exercise is based on subjects' individual VO2max. To simulate the shifts in intensity during real-life competitive stages, the exercise protocol is performed at various shifting intensities, but still at a relative load of subjects' VO2max for inter-individual comparisons. Subjects are allowed to drink water during the exercise.
After exercise, subjects remain inactive for the rest of the trial. Three hours after administration of the study drug, subjects receive a standardized lunch and drink.
Urine is collected 0-1, 1-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 h following administration (corresponding to 0-71 h post exercise).
Venous blood samples are collected through a catheter in the antecubital vein ½, 1½, 3, 5, 7 and 10 h following administration.
Detailed instructions for urine and blood sample collection, processing, storage and transportation will be provided in the Study Procedures Manual) Concerning the Pilot study (EXP1) and the main study (EXP2): Between trials 1 and 2, subjects receive a Relvar® inhaler for six days of home use of 4 puffs per day, which will be monitored by staff via Skype or Facetime video call at the same time of the day as during trial 1. Twenty-four hours after the sixth day of home inhalation, subjects meet for trial 2. In EXP1 Trial A1 and Trial A2 is separated with minimum one week to ensure washout. In EXP2, Trial A1 and A2 and B1 and B2 are separated by at least 1 week to ensure washout.
End of trial The trial is finished when the last patient has been at the last visit. Pilot study (EXP1) is estimated to end at the end of 2018 and the large study is estimated to end at the end of 2019.
- Conditions
- Pharmacokinetics
- Being tested
- Fluticasone Furoate/ Vilanterol Trifenatate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Furoate/ Vilanterol TrifenatateDrug
Also called Relvar Ellipta 184/22 micrograms
Asthma inhalation medication
| Study group | Role | What they receive |
|---|---|---|
| PILOT: 4 puffs once | Experimental | 4 puffs of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 micrograms Receives: Drug: Fluticasone Furoate/ Vilanterol Trifenatate |
| PILOT: 4 puffs once a day for 7 days | Experimental | 4 puffs of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 micrograms for 7 days Receives: Drug: Fluticasone Furoate/ Vilanterol Trifenatate |
| LARGE: 4 puffs once | Experimental | Supra-therapeutic inhalation of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 micrograms (4 puffs) once Receives: Drug: Fluticasone Furoate/ Vilanterol Trifenatate |
| LARGE: 4 puffs once a day for 7 days | Experimental | Supra-therapeutic inhalation of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 micrograms (4 puffs) daily for 7 days Receives: Drug: Fluticasone Furoate/ Vilanterol Trifenatate |
| LARGE: 1 puff once | Experimental | Therapeutic inhalation of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 micrograms (1 puff) once Receives: Drug: Fluticasone Furoate/ Vilanterol Trifenatate |
| LARGE: 1 puff once a day for 7 days | Experimental | Therapeutic inhalation of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 (1 puff) daily for 7 days Receives: Drug: Fluticasone Furoate/ Vilanterol Trifenatate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vilanterol and its metabolites
Urine concentrations of vilanterol and its metabolites (GSK932009 and GW630200) 0-72 hours post drug administration.
Measured: 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
Measured: 0-10 hours post drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start8 Feb 2019
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Vibeke Backer, Bispebjerg Hospital
- Investigators
- Vibeke Backer, Physician, Principal investigator, Respiratory Research Unit, Bispebjerg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03739294
- Sponsor's protocol ID
- WADAVIL2018
- Status last verified
- Jan 2021
- First submitted
- 9 Nov 2018
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urine Concentrations of Vilanterol After Inhaled Administration of Vilanterol/Fluticasone Furoate: Defining a Urine Threshold and Decision Limit for Vilanterol in Doping Control Analysis
- ClinicalTrials.gov ID
- NCT03739294
- Acronym / sponsor ID
- WADAVIL2018
- Conditions
- Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES The main objective of the present study is to investigate urine concentrations of vilanterol and its metabolites (GSK932009 and GW630200) after single dose inhalation of Relvar® (22/184 mcg VI/FF) at therapeutic and supratherapeutic doses. A secondary objective is to investigate whether vilanterol and its metabolites (GSK932009 and GW630200) are present at higher concentrations in urine after seven days of daily inhalation of Relvar® at therapeutic and supratherapeutic doses.
Applicability The results from the study will help establish a urine threshold and decision limit for vilanterol on the WADA list of prohibited substances, thus lessening the administrative burdens associated with TUEs.
Study drug Study treatment in this study is refers to either therapeutic dosage of 22/184 micrograms of vilanterol/fluticasone furoate or four times therapeutic dosage of vilanterol/fluticasone furoate (88/736 micrograms, 4 puffs).
METHODS Study design 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).
Progression from the pilot phase (EXP1) of the study to the second phase (EXP2) of the study depends on a successful pilot phase (EXP1). Success will be concluded provided the pilot phase generates adequate urine concentration data for vilanterol and/or its metabolites (GSK932009, GW630200) with values above the assay limits of quantitation for at least 8 hours post dose. The pilot phase urine concentration data, together with plasma concentration data, will also be used to estimate the urinary concentrations of vilanterol and/or its metabolites at therapeutic and supratherapeutic under various conditions. These estimates will be used to determine whether progression to the second phase of the study is feasible and has a high probability of success in achieving its objectives.
Type of study The study is an open-label study. The study is classified as a Phase II study investigating pharmacokinetics Screening In EXP1 and EXP2, subjects are examined by a medical doctor and electrocardiography (ECG) is performed. Furthermore, subjects' lung function is measured with a spirometer and maximal oxygen consumption (VO2max) and performance are determined during an incremental bike ergometer test to exhaustion. Prior to the test, subjects warm up for 15 min. Subjects are told to keep a cadence of 80-100 rpm during the test. During the warm-up and incremental test, gas exchange is measured breath-by-breath.
After the VO2max-test, inhaler technique is practiced with a demonstrator device.
Pharmacokinetic trials
In EXP1, subjects meet at the laboratory for two trials:
Trial A1: Supra-therapeutic inhalation of Relvar® 22/184 (4 puffs) once Trial A2: Supra-therapeutic inhalation of Relvar® 22/184 (4 puffs) daily for 7 days
In EXP2, subjects meet at the laboratory for four trials:
Trial A1: Supra-therapeutic inhalation of Relvar® 22/184 (4 puffs) once Trial A2: Supra-therapeutic inhalation of Relvar® 22/184 (4 puffs) daily for 7 days Trial B1: Therapeutic inhalation of Relvar® 22/184 (1 puff) once Trial B2: Therapeutic inhalation of Relvar® 22/184 (1 puff) daily for 7 days
During each of the trials, subjects meet in the morning after an overnight fast. A urine sample is collected and subjects ingest a standardized meal and drink. One hour after the meal, study drug is administered during supervision and subjects start performing 60 min of exercise on a bike ergometer. Exercise is based on subjects' individual VO2max. To simulate the shifts in intensity during real-life competitive stages, the exercise protocol is performed at various shifting intensities, but still at a relative load of subjects' VO2max for inter-individual comparisons. Subjects are allowed to drink water during the exercise.
After exercise, subjects remain inactive for the rest of the trial. Three hours after administration of the study drug, subjects receive a standardized lunch and drink.
Urine is collected 0-1, 1-2, 2-4, 4-6, 6-8, 8-12, 12-16, 16-24, 24-36, 36-48 and 48-72 h following administration (corresponding to 0-71 h post exercise).
Venous blood samples are collected through a catheter in the antecubital vein ½, 1½, 3, 5, 7 and 10 h following administration.
Detailed instructions for urine and blood sample collection, processing, storage and transportation will be provided in the Study Procedures Manual) Concerning the Pilot study (EXP1) and the main study (EXP2): Between trials 1 and 2, subjects receive a Relvar® inhaler for six days of home use of 4 puffs per day, which will be monitored by staff via Skype or Facetime video call at the same time of the day as during trial 1. Twenty-four hours after the sixth day of home inhalation, subjects meet for trial 2. In EXP1 Trial A1 and Trial A2 is separated with minimum one week to ensure washout. In EXP2, Trial A1 and A2 and B1 and B2 are separated by at least 1 week to ensure washout.
End of trial The trial is finished when the last patient has been at the last visit. Pilot study (EXP1) is estimated to end at the end of 2018 and the large study is estimated to end at the end of 2019.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PILOT: 4 puffs once | Experimental | Drug: Fluticasone Furoate/ Vilanterol Trifenatate4 puffs of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 micrograms |
| PILOT: 4 puffs once a day for 7 days | Experimental | Drug: Fluticasone Furoate/ Vilanterol Trifenatate4 puffs of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 micrograms for 7 days |
| LARGE: 4 puffs once | Experimental | Drug: Fluticasone Furoate/ Vilanterol TrifenatateSupra-therapeutic inhalation of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 micrograms (4 puffs) once |
| LARGE: 4 puffs once a day for 7 days | Experimental | Drug: Fluticasone Furoate/ Vilanterol TrifenatateSupra-therapeutic inhalation of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 micrograms (4 puffs) daily for 7 days |
| LARGE: 1 puff once | Experimental | Drug: Fluticasone Furoate/ Vilanterol TrifenatateTherapeutic inhalation of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 micrograms (1 puff) once |
| LARGE: 1 puff once a day for 7 days | Experimental | Drug: Fluticasone Furoate/ Vilanterol TrifenatateTherapeutic inhalation of Fluticasone Furoate/ Vilanterol Trifenatate 184/22 (1 puff) daily for 7 days |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Healthy
- Age between 18 and 39 years, both included at time of screening
- Ability to correctly use the inhaler device
- Active at least 5 h pr. week (defined as endurance exercise)
- VO2-max classified as high or very high (table 1)(Astrand, 1960) measured during an incremental test to exhaustion at the screening visit
Key exclusion criteria (3 listed)
- Diagnosis of heart, pulmonary (including asthma in Global initiative for asthma (GINA) 2-5), intestinal and renal diseases
- Allergy towards the active drug or any substances used in the drug
- Non-compliance with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone Furoate/ Vilanterol TrifenatateAlso: Relvar Ellipta 184/22 microgramsAsthma inhalation medication | Drug | LARGE: 1 puff once, LARGE: 1 puff once a day for 7 days, LARGE: 4 puffs once, LARGE: 4 puffs once a day for 7 days, PILOT: 4 puffs once, PILOT: 4 puffs once a day for 7 days |
Primary outcome
Vilanterol and its metabolites
Time frame: 72 hours post drug administration
Urine concentrations of vilanterol and its metabolites (GSK932009 and GW630200) 0-72 hours post drug administration.
Vilanterol and its metabolites
Time frame: 0-10 hours post drug administration
Blood concentrations of vilanterol and its metabolites (GSK932009 and GW630200) 0-10 hours post drug administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vibeke Backer, Physician principal investigator
Respiratory Research Unit, Bispebjerg Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluticasone Furoate/ Vilanterol Trifenatate in people with Pharmacokinetics, run by Bispebjerg Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vilanterol and its metabolites (time frame: 72 hours post drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.