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AsthmaPhase 1NCT01000597

Study to Look at and Compare How Inhaled and Intravenous Fluticasone Furoate is Processed by the Body in Healthy Caucasian, Japanese, Korean and Chinese Subjects

A Phase 1 study testing fluticasone furoate in people with Asthma, run by GlaxoSmithKline at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Previous studies have shown potentially higher exposure to fluticasone furoate in Japanese subjects compared with Caucasian subjects. The reasons for these potential differences are unclear. Read more about this study

Who is it for?
Ages 20 to 64 years
Conditions the study is for
Asthma
What is being tested?
fluticasone furoate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteAustralia
Study dates
17 Sep 2009to 23 Dec 2009
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 20 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Healthy male or female between 20 and 64 years of age inclusive
  • Caucasian, Japanese, Korean or Chinese
  • Body mass index (BMI) for Caucasians within the range 18.5-29.0 kg/m2 (inclusive). For East Asians BMI within the range 18.5-24.9 kg/m2 (inclusive) and height 1.55m-1.85m (inclusive)
  • Non-smokers
  • AST, ALT, alkaline phosphatase and bilirubin </=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
  • No significant abnormality on 12-lead ECG at screening
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  • No significant abnormality on the Holter ECG at screening
  • FEV1 >/= 85% predicted at screening
  • Capable of giving written informed consent
  • Subjects who are able to use the inhalation device satisfactorily

Who cannot join

  • As a result of screening medical exam, 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.
  • Any history of breathing problems in adult life
  • Pregnant or lactating females
  • Subject has been treated for or diagnosed with depression within six months of screening or has a history of significant psychiatric illness
  • Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
  • Subjects who have suffered an upper or lower respiratory tract infection within 4 weeks of the screening visit.
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  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
  • History of milk protein allergy.
  • 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.
  • Subject has taken oral corticosteroids less than 8 weeks before the screening visit.
  • Subject has taken inhaled, intranasal or topical steroids less than 4 weeks before the screening visit.
  • History of alcohol/drug abuse or dependence within 12 months of the study
  • 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.
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
  • Positive for HIV antibodies.
  • Positive pre-study urine drug screen or when randomly tested during the study.
  • Positive carbon monoxide or alcohol breath test at screening or on admission to the Unit.
  • Positive urine cotinine test at screening.
  • Consumption of seville oranges, pomelos (members of the grapefruit family) or grapefruit juice from 7 days prior to the first dose of study medication.
  • Unwillingness or inability to follow the procedures outlined in the protocol.
  • Subject is mentally or legally incapacitated.

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • GSK Investigational Site

    Randwick, New South Wales, 2031

Other trials in Australia

About this study

Official title: An Open-label, Randomised, Two-way Crossover Study, to Evaluate and Compare the Pharmacokinetics of Fluticasone Furoate, Administered From a Novel Dry Powder Device (Repeat Dose) and Intravenously (Single Dose), in Healthy Caucasian, Japanese, Korean and Chinese Subjects

Previous studies have shown potentially higher exposure to fluticasone furoate in Japanese subjects compared with Caucasian subjects. The reasons for these potential differences are unclear. Therefore this study is being done to look at and compare how fluticasone furoate is processed by the body in healthy Caucasian, Japanese, Korean and Chinese subjects after inhaled and intravenous administration. The data obtained will be used to help in the clinical development of the drug in Japanese and other East Asian populations.

Read the detailed description

Corticosteroids are a highly effective anti-inflammatory therapy in allergic conditions such as asthma and rhinitis. Fluticasone Furoate (FF) is a novel corticosteroid with potent glucocorticoid activity similar to fluticasone propionate and mometasone furoate. Phase II studies have shown FF to be an effective once daily inhaled steroid for asthma and it is being developed as a potential steroid component in a once daily combination with GW642444M, for once-daily administration for the maintenance treatment of asthma and COPD. FF is approved worldwide (including the US, EU and Japan) as an intranasal steroid for the treatment of allergic rhinitis (VERAMYST™ /AVAMYS™ /ALLERMIST™). Previous inter-study comparisons have indicated potentially higher systemic exposure to FF in Japanese subjects compared with treatment groups that recruited predominantly Caucasian subjects. The reasons for these potential differences are unclear. This study is being performed to evaluate and directly compare the PK and systemic PD effects of FF in healthy Caucasian, Japanese, Korean and Chinese subjects when delivered from the novel dry powder inhaler and intravenously. The data obtained will be used to facilitate clinical development of the FF/GW642444 combination in Japanese and other East Asian populations.

Conditions
Asthma
Being tested
fluticasone furoate
Keywords
pharmacokinetics, serum cortisol, pharmacodynamics, fluticasone furoate, healthy Caucasian, Japanese, Korean and Chinese subjects
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • fluticasone furoateDrug

    Seven inhaled doses of 200mcg FF given once daily in the morning (Part A; Days 1-7) followed by seven inhaled doses of 800mcg FF given once daily in the morning (Part B; Day 1 and Days 3-8, i.e. no dose on Day 2).

    A single intravenous dose of 250mcg FF given over 20 minutes (Day 1).

Study groups in NCT01000597
Study groupRoleWhat they receive
Treatment YOtherSeven inhaled doses of 200mcg FF given once daily in the morning (Part A; Days 1-7) followed by seven inhaled doses of 800mcg FF given once daily in the morning (Part B; Day 1 and Days 3-8, i.e. no dose on Day 2).
Receives: Drug: fluticasone furoate
Treatment ZOtherA single intravenous dose of 250mcg FF given over 20 minutes (Day 1).
Receives: Drug: fluticasone furoate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FF Pharmacokinetic parameters: AUC, Cmax, t1/2, tmax for inhaled and intravenous treatments. Volume of distribution (V) and plasma clearance (CL) for intravenous FF

    Measured: up to 72hr PK sampling periods profiles on 4 separate occasions over a total period of approximately 4-5 weeks

Secondary outcomes (5)

  1. Pharmacokinetic parameters MRT for both inhaled and intravenous treatments; MAT, AUC(0-t) for 200mcg dose,observed accumulation (Ro) and absolute bioavailability for inhaled treatment

    Measured: up to 72hr PK sampling periods profiles on 4 separate occasions over a total period of approximately 4-5 weeks

  2. Pharmacodynamics; serum cortisol for 200mcg inhaled FF treatment only: 24 hour weighted mean (on Day -1 and Day 7)

    Measured: Two 24 hour sampling periods approximately 1 week apart

  3. • Ratio of twenty-four hour urine cortisol to 6-beta-hydroxy-cortisol (on Day -1 of first treatment period only). Plasma 4-beta-hydroxy-cholesterol (single sample, on Day -1 of first treatment period only). Measure of baseline CYP3A4 activity

    Measured: One collection period of up to 24 hours

  4. • Vital signs, 12-lead ECG, Clinical laboratory tests, forced expiratory volume in 1 second (FEV1) (at screening), peak expiratory flow rate (PEFR), AEs.

    Measured: Throughout study; approx 10 weeks

  5. Quantity of the total emitted dose (TED), ex-throat dose (ETD) and mass less than 2 micrometer of inhaled FF for each subject, assessed by pharyngometry, inhalation profile, breath hold and lung volume measurements

    Measured: Throughout study from screening to end of treatment periods; approximately 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2009 (estimated)
  2. Study start17 Sep 2009
  3. Primary completion23 Dec 2009
  4. Study completion23 Dec 2009

Resources

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
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01000597
Sponsor's protocol ID
113477
Status last verified
Jun 2017
First submitted
22 Oct 2009
Last updated
22 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing fluticasone furoate in people with Asthma, run by GlaxoSmithKline at 1 site in Australia.

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 10 inclusion and 23 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 22 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 Australia. 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?

FF Pharmacokinetic parameters: AUC, Cmax, t1/2, tmax for inhaled and intravenous treatments. Volume of distribution (V) and plasma clearance (CL) for intravenous FF (time frame: up to 72hr PK sampling periods profiles on 4 separate occasions over a total period of approximately 4-5 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01000597.

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 22 Jun 2017.

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