AsthmaPhase 1NCT01213849
Dose Proportionality Study: Blood Levels of Fluticasone Furoate (FF) and Vilanterol (VI) Following Different Doses of FF/VI Via an Inhaler
A Phase 1 study testing Fluticasone furoate 50 mcg (4 inhalations), Fluticasone furoate 100 mcg (4 inhalations) and Fluticasone furoate 200 mcg (4 inhalations) in people with Asthma, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI)following single dose administration of FF/VI via the novel dry powder inhaler in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone furoate 50 mcg (4 inhalations), Fluticasone furoate 100 mcg (4 inhalations) and Fluticasone furoate 200 mcg (4 inhalations)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Oct 2010to 25 Nov 2010
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <or= 1.5xULN
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 65 years of age inclusive.
- A female subject is eligible to participate if she is of:
- Non-child-bearing potential defined as post-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea.
- Child-bearing potential and agrees to use one of the approved contraception methods until 16 weeks after the last dose.
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- Male subjects with female partners of child-bearing potential must agree to use one of the approved contraception methods until 16 weeks after the last dose.
- Body Mass Index (BMI) within range 18.5-29.0 kg/m2 (inclusive).
- Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Average QTcF < 450 msec.
- No clinically significant abnormality on the Holter electrocardiogram (ECG) at screening.
- Subjects who are current non-smokers, who have not used any tobacco products in the 12 month period preceding the screening visit, and have a pack history of < or = 5 pack years.
- Able to satisfactorily use the dry powder inhaler.
Who cannot join
- As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
- The subject has a history of breathing problems in adult life (e.g. history of asthmatic symptomatology). Screening lung function tests (forced expiratory volume in 1 minute (FEV1)) will be performed to confirm normal lung function parameters (>or=85% predicted).
- Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
- A positive HIV antibody.
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- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- History of heavy regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 units for males or >14 units for females.
- History or regular use of tobacco- or nicotine-containing products within 12 months prior to screening.
- Positive carbon monoxide or alcohol breath test at screening or on admission to the unit.
- A positive pre-study urine drug screen or when randomly tested during the study.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- The subject has taken systemic, oral or depot corticosteroids less than 12 weeks before the screening visit.
- The subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
- History of sensitivity or adverse reaction to any of the study medications including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or an intranasal, inhaled or systemic corticosteroid; known suspected sensitivity to the constituents of the new powder inhaler (lactose or magnesium stearate) or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates participation.
- History of severe milk protein allergy.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within 3 months of the start of the study.
- Pregnant females as determined by positive serum hCG test at screening or by positive serum/urine hCG test prior to dosing.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomised, 3-way Crossover Single Dose Study to Demonstrate Dose Proportionality of Fluticasone Furoate (FF) and Equivalence of Vilanterol (VI) When Administered as FF/VI Inhalation Powder From the Novel Dry Powder Inhaler in Healthy Subjects.
The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI)following single dose administration of FF/VI via the novel dry powder inhaler in healthy subjects.
Read the detailed description
The study will be an open-label, randomised, 3-way cross-over single dose study in 24 healthy subjects to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) following single dose administration of FF/VI via the novel dry powder inhaler. In each of 3 treatment periods, subjects will receive 4 inhalations of 50/25 mcg, 100/25 mcg, 200/25 mcg FF/VI. Blood samples will be taken for pharmacokinetic analysis and safety (12-lead ECGs, clinical laboratory test, vital signs, adverse events) will be monitored following each dose.
- Conditions
- Asthma
- Being tested
- Fluticasone furoate 50 mcg (4 inhalations), Fluticasone furoate 100 mcg (4 inhalations), Fluticasone furoate 200 mcg (4 inhalations), Vilanterol 25 mcg (4 inhalations)
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone furoate 50 mcg (4 inhalations)Drug
4 inhalations of 50 mcg strength
Fluticasone furoate 100 mcg (4 inhalations)Drug
4 inhalations of 100 mcg strength
Fluticasone furoate 200 mcg (4 inhalations)Drug
4 inhalations of 200 mcg strength
Vilanterol 25 mcg (4 inhalations)Drug
4 inhalations of 25 mcg strength
| Study group | Role | What they receive |
|---|---|---|
| 200/100 mcg fluticasone furoate/vilanterol | Experimental | 4 inhalations of 50/25 mcg fluticasone furoate/vilanterol Receives: Drug: Fluticasone furoate 50 mcg (4 inhalations); Drug: Vilanterol 25 mcg (4 inhalations) |
| 400/100 mcg fluticasone furoate/vilanterol | Experimental | 4 inhalations of 100/25 mcg fluticasone furoate/vilanterol Receives: Drug: Fluticasone furoate 100 mcg (4 inhalations); Drug: Vilanterol 25 mcg (4 inhalations) |
| 800/100 mcg fluticasone furoate/vilanterol | Experimental | 4 inhalations of 200/25 mcg fluticasone furoate/vilanterol Receives: Drug: Fluticasone furoate 200 mcg (4 inhalations) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluticasone furoate area under concentration-time curve (AUC)
Measured: 48 hours post-dose
Fluticasone furoate maximum observed concentration (Cmax)
Measured: 48 hours post-dose
Vilanterol area under concentration-time curve (AUC)
Measured: 48 hours post-dose
Vilanterol maximum observed concentration (Cmax)
Measured: 48 hours post-dose
Secondary outcomes (2)
Fluticasone furoate time of occurence of maximum concentration (tmax)
Measured: 48 hours post-dose
Vilanterol time of occurence of maximum concentration (tmax)
Measured: 48 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study start4 Oct 2010
- Primary completion25 Nov 2010
- Study completion25 Nov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01213849
- Sponsor's protocol ID
- 102932
- Status last verified
- Jun 2017
- First submitted
- 1 Oct 2010
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, 3-way Crossover Single Dose Study to Demonstrate Dose Proportionality of Fluticasone Furoate (FF) and Equivalence of Vilanterol (VI) When Administered as FF/VI Inhalation Powder From the Novel Dry Powder Inhaler in Healthy Subjects.
- ClinicalTrials.gov ID
- NCT01213849
- Acronym / sponsor ID
- 102932
- Conditions
- Asthma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 4 Oct 2010 (actual)
- Primary completion
- 25 Nov 2010 (actual)
- Study completion
- 25 Nov 2010 (actual)
- First posted
- 4 Oct 2010 (estimated)
- 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.
The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI)following single dose administration of FF/VI via the novel dry powder inhaler in healthy subjects.
Detailed description
The study will be an open-label, randomised, 3-way cross-over single dose study in 24 healthy subjects to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of vilanterol (VI) following single dose administration of FF/VI via the novel dry powder inhaler. In each of 3 treatment periods, subjects will receive 4 inhalations of 50/25 mcg, 100/25 mcg, 200/25 mcg FF/VI. Blood samples will be taken for pharmacokinetic analysis and safety (12-lead ECGs, clinical laboratory test, vital signs, adverse events) will be monitored following each dose.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 200/100 mcg fluticasone furoate/vilanterol | Experimental | Drug: Fluticasone furoate 50 mcg (4 inhalations), Drug: Vilanterol 25 mcg (4 inhalations)4 inhalations of 50/25 mcg fluticasone furoate/vilanterol |
| 400/100 mcg fluticasone furoate/vilanterol | Experimental | Drug: Fluticasone furoate 100 mcg (4 inhalations), Drug: Vilanterol 25 mcg (4 inhalations)4 inhalations of 100/25 mcg fluticasone furoate/vilanterol |
| 800/100 mcg fluticasone furoate/vilanterol | Experimental | Drug: Fluticasone furoate 200 mcg (4 inhalations)4 inhalations of 200/25 mcg fluticasone furoate/vilanterol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT), alkaline phosphatase and bilirubin <or= 1.5xULN
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Male or female between 18 and 65 years of age inclusive.
- A female subject is eligible to participate if she is of:
- Non-child-bearing potential defined as post-menopausal females with a documented tubal ligation or hysterectomy, or postmenopausal defined as 12 months of spontaneous amenorrhea.
Key exclusion criteria (24 listed)
- As a result of medical interview, physical examination or screening investigations, the principal investigator or delegate physician deems the subject unsuitable for the study. Subjects must not have a systolic blood pressure above 145 mmHg or a diastolic pressure above 85 mmHg unless the Investigator confirms that it is satisfactory for their age.
- The subject has a history of breathing problems in adult life (e.g. history of asthmatic symptomatology). Screening lung function tests (forced expiratory volume in 1 minute (FEV1)) will be performed to confirm normal lung function parameters (>or=85% predicted).
- Subjects who have suffered a lower respiratory tract infection within 4 weeks of the screening visit.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- The subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness.
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 50 mcg (4 inhalations)4 inhalations of 50 mcg strength | Drug | 200/100 mcg fluticasone furoate/vilanterol |
| Fluticasone furoate 100 mcg (4 inhalations)4 inhalations of 100 mcg strength | Drug | 400/100 mcg fluticasone furoate/vilanterol |
| Fluticasone furoate 200 mcg (4 inhalations)4 inhalations of 200 mcg strength | Drug | 800/100 mcg fluticasone furoate/vilanterol |
| Vilanterol 25 mcg (4 inhalations)4 inhalations of 25 mcg strength | Drug | 200/100 mcg fluticasone furoate/vilanterol, 400/100 mcg fluticasone furoate/vilanterol |
Primary outcome
Fluticasone furoate area under concentration-time curve (AUC)
Time frame: 48 hours post-dose
Fluticasone furoate maximum observed concentration (Cmax)
Time frame: 48 hours post-dose
Vilanterol area under concentration-time curve (AUC)
Time frame: 48 hours post-dose
Vilanterol maximum observed concentration (Cmax)
Time frame: 48 hours post-dose
2 secondary outcomes
Fluticasone furoate time of occurence of maximum concentration (tmax)
Time frame: 48 hours post-dose
Vilanterol time of occurence of maximum concentration (tmax)
Time frame: 48 hours post-dose
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 14 Jun 2017.
- Results for study 102932 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fluticasone furoate 50 mcg (4 inhalations), Fluticasone furoate 100 mcg (4 inhalations) and Fluticasone furoate 200 mcg (4 inhalations) in people with Asthma, run by GlaxoSmithKline at 1 site in United Kingdom.
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 13 inclusion and 24 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 14 Jun 2017. 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 United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Fluticasone furoate area under concentration-time curve (AUC) (time frame: 48 hours post-dose). The study lists 4 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 14 Jun 2017.