AsthmaPhase 1NCT01485445
Bioequivalence Study to Compare Fluticasone Furoate (FF) 1-strip Inhaler With FF 2-strip Inhaler and With FF/Vilanterol Combination
A Phase 1 study testing Fluticasone Furoate (200mcg unit strength) and Fluticasone Furoate/Vilanterol (200/25mcg unit strength) in people with Asthma, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
The purpose of this study is to determine the bioequivalence of fluticasone furoate (FF) inhalation powder (single strip configuration) compared with FF inhalation powder (two strip configuration) and compared with FF / vilanterol (VI) inhalation powder. 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 (200mcg unit strength) and Fluticasone Furoate/Vilanterol (200/25mcg unit strength)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 21 Dec 2011to 12 Mar 2012
- 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
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-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 contraception methods listed in Section 8.1 of the protocol for an appropriate period of time prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until completion of the follow-up visit.
- Body Mass Index (BMI) within the range 18.5-29.0 kg/m2 (inclusive).
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase and bilirubin are less than or equal to 1.5x Upper Limit of Normal (ULN) (isolated bilirubin greater than 1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin is less than 35%).
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- Average QTcF less than 450 msec.
- Forced Expiratory Volume in 1 second (FEV1) greater than or equal to 85% predicted 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 less than or equal to 5 pack years (number of pack years = (number of cigarettes per day/20) x number of years smoked)
- Able to satisfactorily use the novel dry powder inhaler (NDPI)
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. Subjects must have signed the Informed Consent Form (ICF) prior to the commencement of any screening activities.
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 140 mmHg or a diastolic pressure above 90 mmHg.
- The subject has a history of breathing problems in adult life (e.g. history of asthmatic symptomatology). Screening lung function tests (FEV1) will be performed to confirm normal lung function parameters (greater than or equal to 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 pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
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- A positive test for Human Immunodeficiency Virus (HIV) antibody.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of greater than 21 units for males or greater than 14 units for females.
- A positive pre-study drug/alcohol screen or when randomly tested during the study.
- Positive cotinine and urine alcohol test at screening or on admission to the Unit.
- 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: 30 days, 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.
- 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.
- 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.
- History of sensitivity to any of the study medications, including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled or systemic corticosteroid therapy; known or suspected sensitivity to the constituents of the new powder inhaler (i.e. 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.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 30 day period.
- 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.
- Vulnerable subjects (eg kept in detention) or Parexel / GSK employees
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomised, Replicate, Six-way Crossover, Single Dose Study to Determine the Bioequivalence of Fluticasone Furoate (FF) Inhalation Powder (Single Strip Configuration) Compared With FF Inhalation Powder (Two Strip Configuration) and Compared With FF / Vilanterol (VI) Inhalation Powder Administered Via the Novel Dry Powder Inhaler.
The purpose of this study is to determine the bioequivalence of fluticasone furoate (FF) inhalation powder (single strip configuration) compared with FF inhalation powder (two strip configuration) and compared with FF / vilanterol (VI) inhalation powder. Fluticasone furoate (FF), is being developed both as a monotherapy for the treatment of asthma and in combination with vilanterol (VI) for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). Thirty healthy male and female subjects will be enrolled in the study to ensure twenty-four evaluable subjects.
Read the detailed description
Fluticasone furoate (FF; GW685698), a novel corticosteroid, is being developed both as a monotherapy for the treatment of asthma and in combination with vilanterol (VI; GW642444) for the treatment of asthma and COPD. The novel dry powder inhaler (NDPI) will be used to deliver both FF monotherapy and the FF/VI combination. The NDPI can be used with either a single strip or two strips, the single strip being used for FF monotherapy and two strips being used to deliver the FF/VI combination. In some previous FF monotherapy studies, including the phase IIB programme, conducted using the NDPI, the inhaler contained two strips (FF in the first strip and matched VI placebo in the second strip). This two strip configuration has been used for the majority of FF monotherapy treatment arms in previous and ongoing studies. The aim of this study is to determine the bioequivalence of FF monotherapy (single strip) compared with FF monotherapy (two strip), and to determine the bioequivalence of FF monotherapy (single strip) compared with FF/VI, administered via the NDPI. This data will facilitate the inclusion of FF monotherapy (two strip) data and FF/VI combination data to support the FF monotherapy product development. This will be a randomised, open-label, replicate, six-way crossover, single dose study in healthy male and female subjects. Thirty healthy male and female subjects will be enrolled in this study to ensure twenty-four evaluable subjects.
Pharmacokinetic samples will be taken over 36 hours. Safety will be assessed by adverse event (AE) monitoring throughout the study.
- Conditions
- Asthma
- Being tested
- Fluticasone Furoate (200mcg unit strength), Fluticasone Furoate/Vilanterol (200/25mcg unit strength)
- Keywords
- bioequivalence, pharmacokinetics, Fluticasone Furoate, Vilanterol
- 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 (200mcg unit strength)Drug
inhalation powder
Fluticasone Furoate/Vilanterol (200/25mcg unit strength)Drug
inhalation powder
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone Furoate (single strip configuration) | Experimental | 400mcg, administered as 2 inhalations of 200mcg Receives: Drug: Fluticasone Furoate (200mcg unit strength) |
| Fluticasone Furoate (two strip configuration) | Experimental | 400mcg, administered as 2 inhalations of 200mcg. Second strip contains lactose and magnesium stearate Receives: Drug: Fluticasone Furoate (200mcg unit strength) |
| Fluticasone Furoate/Vilanterol | Experimental | 400/50mcg, administered as 2 inhalations of 200/25mcg Receives: Drug: Fluticasone Furoate/Vilanterol (200/25mcg unit strength) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters for Fluticasone Furoate (FF) for all study participants
Measurement of amount of FF in the blood of study participants. From the plasma concentration-time data the following PK parameters will be determined as data permits: Area Under Curve from pre-dose to infinite time (AUC)(0-inf), Area Under Curve from pre-dose to time of last quantifiable concentration (AUC)(0-t), maximum plasma concentration (Cmax)
Measured: 15 time points between pre-dose and 36 hours post-dose in each of the six treatment periods
Secondary outcomes (2)
Pharmacokinetic parameters for Fluticasone Furoate (FF) for all study participants
Measurement of amount of FF in the blood of study participants. From the plasma concentration-time data the following PK parameters will be determined as data permits: time to maximum plasma concentration (tmax), half-life (t1/2)
Measured: 15 time points between pre-dose and 36 hours post-dose in each of the six treatment periods
Adverse events (AEs) for all study participants
Measurement of types of AEs reported, severity and relationship to study drug
Measured: From the start of first dosing until follow-up (approximately 7 weeks per subject)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2011 (estimated)
- Study start21 Dec 2011
- Primary completion12 Mar 2012
- Study completion12 Mar 2012
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT01485445
- Sponsor's protocol ID
- 115440
- Status last verified
- Jun 2017
- First submitted
- 1 Dec 2011
- Last updated
- 12 Jun 2017
- Results posted
- 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 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomised, Replicate, Six-way Crossover, Single Dose Study to Determine the Bioequivalence of Fluticasone Furoate (FF) Inhalation Powder (Single Strip Configuration) Compared With FF Inhalation Powder (Two Strip Configuration) and Compared With FF / Vilanterol (VI) Inhalation Powder Administered Via the Novel Dry Powder Inhaler.
- ClinicalTrials.gov ID
- NCT01485445
- Acronym / sponsor ID
- 115440
- Conditions
- Asthma
- Keywords
- bioequivalence, pharmacokinetics, Fluticasone Furoate, Vilanterol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Dec 2011 (actual)
- Primary completion
- 12 Mar 2012 (actual)
- Study completion
- 12 Mar 2012 (actual)
- First posted
- 5 Dec 2011 (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 determine the bioequivalence of fluticasone furoate (FF) inhalation powder (single strip configuration) compared with FF inhalation powder (two strip configuration) and compared with FF / vilanterol (VI) inhalation powder. Fluticasone furoate (FF), is being developed both as a monotherapy for the treatment of asthma and in combination with vilanterol (VI) for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). Thirty healthy male and female subjects will be enrolled in the study to ensure twenty-four evaluable subjects.
Detailed description
Fluticasone furoate (FF; GW685698), a novel corticosteroid, is being developed both as a monotherapy for the treatment of asthma and in combination with vilanterol (VI; GW642444) for the treatment of asthma and COPD. The novel dry powder inhaler (NDPI) will be used to deliver both FF monotherapy and the FF/VI combination. The NDPI can be used with either a single strip or two strips, the single strip being used for FF monotherapy and two strips being used to deliver the FF/VI combination. In some previous FF monotherapy studies, including the phase IIB programme, conducted using the NDPI, the inhaler contained two strips (FF in the first strip and matched VI placebo in the second strip). This two strip configuration has been used for the majority of FF monotherapy treatment arms in previous and ongoing studies. The aim of this study is to determine the bioequivalence of FF monotherapy (single strip) compared with FF monotherapy (two strip), and to determine the bioequivalence of FF monotherapy (single strip) compared with FF/VI, administered via the NDPI. This data will facilitate the inclusion of FF monotherapy (two strip) data and FF/VI combination data to support the FF monotherapy product development. This will be a randomised, open-label, replicate, six-way crossover, single dose study in healthy male and female subjects. Thirty healthy male and female subjects will be enrolled in this study to ensure twenty-four evaluable subjects.
Pharmacokinetic samples will be taken over 36 hours. Safety will be assessed by adverse event (AE) monitoring throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fluticasone Furoate (single strip configuration) | Experimental | Drug: Fluticasone Furoate (200mcg unit strength)400mcg, administered as 2 inhalations of 200mcg |
| Fluticasone Furoate (two strip configuration) | Experimental | Drug: Fluticasone Furoate (200mcg unit strength)400mcg, administered as 2 inhalations of 200mcg. Second strip contains lactose and magnesium stearate |
| Fluticasone Furoate/Vilanterol | Experimental | Drug: Fluticasone Furoate/Vilanterol (200/25mcg unit strength)400/50mcg, administered as 2 inhalations of 200/25mcg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-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 contraception methods listed in Section 8.1 of the protocol for an appropriate period of time prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until completion of the follow-up visit.
- Body Mass Index (BMI) within the range 18.5-29.0 kg/m2 (inclusive).
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 140 mmHg or a diastolic pressure above 90 mmHg.
- The subject has a history of breathing problems in adult life (e.g. history of asthmatic symptomatology). Screening lung function tests (FEV1) will be performed to confirm normal lung function parameters (greater than or equal to 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 (200mcg unit strength)inhalation powder | Drug | Fluticasone Furoate (single strip configuration), Fluticasone Furoate (two strip configuration) |
| Fluticasone Furoate/Vilanterol (200/25mcg unit strength)inhalation powder | Drug | Fluticasone Furoate/Vilanterol |
Primary outcome
Pharmacokinetic parameters for Fluticasone Furoate (FF) for all study participants
Time frame: 15 time points between pre-dose and 36 hours post-dose in each of the six treatment periods
Measurement of amount of FF in the blood of study participants. From the plasma concentration-time data the following PK parameters will be determined as data permits: Area Under Curve from pre-dose to infinite time (AUC)(0-inf), Area Under Curve from pre-dose to time of last quantifiable concentration (AUC)(0-t), maximum plasma concentration (Cmax)
2 secondary outcomes
Pharmacokinetic parameters for Fluticasone Furoate (FF) for all study participants
Time frame: 15 time points between pre-dose and 36 hours post-dose in each of the six treatment periods
Adverse events (AEs) for all study participants
Time frame: From the start of first dosing until follow-up (approximately 7 weeks per subject)
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 12 Jun 2017.
- Results for study 115440 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 (200mcg unit strength) and Fluticasone Furoate/Vilanterol (200/25mcg unit strength) in people with Asthma, run by GlaxoSmithKline at 1 site in Germany.
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 11 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 12 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 Germany. 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?
Pharmacokinetic parameters for Fluticasone Furoate (FF) for all study participants (time frame: 15 time points between pre-dose and 36 hours post-dose in each of the six treatment periods). 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 12 Jun 2017.