Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Perennial and Seasonal
Intervention: FF nasal spray (Drug); MF nasal spray (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
The purpose of this study is to provide information on whether subjects with allergic
rhinitis (AR) prefer the administration of fluticasone furoate (FF) nasal spray or
mometasone furoate (MF) nasal spray based on how the products feel to the subjects when
administered.
This Phase IV interventional study is a multi-center, randomized, double-blind, single-dose,
cross-over subject preference study to evaluate and compare patient preference for FF
[(total dose of 110 microgram (mcg)] and MF (total dose of 200 mcg) nasal sprays in subjects
with allergic rhinitis. These two commonly used nasal sprays use different actuation systems
(FF nasal spray is side-actuated; MF nasal spray is top-actuated) and this study will
evaluate whether this difference is reflected in the patient-assessed attributes of the two
nasal sprays. The attributes or properties which are being assessed by the subjects for
these nasal sprays include smell, taste & aftertaste, drip down the throat, run out of the
nose, urge to sneeze, and irritation.
The single-day study per subject comprises screening and all treatments and procedures.
Eligible subjects will be randomized 1: 1 to a cross-over treatment schedule so that all
subjects receive both products. One group of subjects will have two sprays of FF
administered in each nostril whilst a second group will have two sprays of MF administered
into each nostril. At 30 (± 5) minutes after the first study medication treatment, the two
groups will switch. The first group will then have two sprays of MF administered into each
nostril and the second group will then have two sprays of FF administered into each nostril.
After each treatment the subject will complete two sets of attributes questionnaires
('immediate' and 'delayed'). A subject-rated 'immediate' attributes questionnaire will be
completed immediately following each treatment and a subject-rated 'delayed' attributes
questionnaire will be completed approximately 2 minutes after each treatment. Upon
completion of the second set of these two attributes questionnaires (immediate and delayed),
a preference questionnaire will be completed by the subject. In the preference
questionnaire, the subject states their preferred treatment, if any, for each of the product
attributes, and finally states their overall preferred treatment, if any.
There will be follow-up contact with the subject 24 (± 4) and 96 (± 4) hours after
administration of the last treatment. The study is planned to enroll about 300 subjects.
Clinical Details
Official title: A Patient Preference Evaluation Study of Fluticasone Furoate Nasal Spray and Mometasone Furoate Nasal Spray in Subjects With Allergic Rhinitis
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)
Primary outcome: Overall subject preference for nasal spray (FF or MF)
Secondary outcome: Subject preference for individual attributes of nasal sprays (FF or MF)Subject ratings for individual attributes of nasal sprays (FF versus MF)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female subjects who are between 18 to 65 years of age, inclusive at the time
of signing the informed consent.
- Severity of disease: Subjects who meet the below criteria and who may also have
vasomotor rhinitis are eligible for the study. A positive skin test to perennial (for
example, but not limited to, animal dander, house dust mites, cockroach, mould) and /
or seasonal (for example, but not limited to, grass, tree, weed, ragweed) allergen
within 12 months prior to Screening. If a subject has not been tested in the 12
months prior to Screening, a positive skin test (by prick method) is required at
Screening. A positive skin test is defined as a wheal >=3 millimeters (mm) larger
than the diluent control for prick testing. In vitro tests for specific
Immunoglobulin E (IgE) [such as radioallergosorbent test (RAST), paper
radioimmunosorbent test (PRIST)] will not be allowed as a diagnosis of AR.
- A female subject is eligible to participate if she is not pregnant [as confirmed by a
negative urine (preferred) or serum human chorionic gonadotrophin (hCG) test], not
lactating, and at least one of the following conditions applies: (a) Non-reproductive
potential defined as premenopausal females with a documented tubal ligation or
documented hysteroscopic tubal occlusion procedure with follow-up confirmation of
bilateral tubal occlusion or hysterectomy or documented bilateral oophorectomy; or
postmenopausal defined as 12 months of spontaneous amenorrhea. Females on hormone
replacement therapy (HRT) and whose menopausal status is in doubt will be required to
use one of the highly effective contraception methods if they wish to continue their
HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of
post-menopausal status prior to study enrolment. (b) Reproductive potential and
agrees to follow one of the options listed below in the GlaxoSmithKline (GSK)
modified list of highly effective methods for avoiding pregnancy in females of
reproductive potential (FRP) requirements from 30 days prior to the first dose of
study medication and until at least 4 days after the last dose of study medication.
The GSK modified list of highly effective methods includes: contraceptive subdermal
implant that meets the standard operating procedure (SOP) effectiveness criteria
including a <1% rate of failure per year, as stated in the product label;
Intrauterine device or intrauterine system that meets the SOP effectiveness criteria
including a <1% rate of failure per year, as stated in the product label; Oral
contraceptive; either combined or progestogen alone; Injectable progestogen;
Contraceptive vaginal ring; Percutaneous contraceptive patches; Male partner
sterilization with documentation of azoospermia prior to the female subject's entry
into the study, and this male is the sole partner for that subject. This list does
not apply to FRP with same sex partners, when this is their preferred and usual
lifestyle or for subjects who are and will continue to be abstinent from
penile-vaginal intercourse on a long term and persistent basis.
- A male subject is eligible to participate if (a) subjects with female partners of
child bearing potential comply with the following contraception requirements from the
time of first dose of study medication until at least 4 days after the last dose of
study medication; (b) Vasectomy with documentation of azoospermia; (c) Male condom
plus partner use of one of the contraceptive options: Contraceptive subdermal implant
that meets the SOP effectiveness criteria including a <1% rate of failure per year,
as stated in the product label; Intrauterine device or intrauterine system that meets
the SOP effectiveness criteria including a <1% rate of failure per year, as stated in
the product label; Oral contraceptive, either combined or progestogen alone,
Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive
patches. These allowed methods of contraception are only effective when used
consistently, correctly and in accordance with the product label. The investigator is
responsible for ensuring that subjects understand how to properly use these methods
of contraception.
- Understanding of questionnaires: In the opinion of the investigator, subject
possesses a degree of understanding of the written questionnaires that enables the
subject to complete study participation.
- Informed consent: Capable of giving signed informed consent which includes compliance
with the requirements and restrictions listed in the consent form and in the
protocol.
Exclusion Criteria:
- Concurrent conditions / Medical History: Concomitant medical conditions defined as
but not limited to a historical or current evidence of clinically significant
uncontrolled disease of any body system (e. g., tuberculosis, psychological disorders,
eczema, uncontrolled diabetes, immunosuppression). Significant is defined as any
disease that, in the opinion of the investigator, would put the safety of the subject
at risk through study participation, or compromise the scientific validity of the
study; A respiratory infection at time of study participation; A condition associated
with anosmia (loss of smell) and ageusia (loss of taste) within 2 weeks of study -
may be self-reported condition experienced by the subject; Clinical evidence of a
Candida infection of the nose or oropharynx; Acute rhinosinusitis within 60 days of
screening; Current severe physical obstruction of the nose (e. g., deviated septum or
nasal polyp) or nasal septal perforation or nasal trauma or nasal ulcers; History of
haemorrhagic diathesis, atrophic rhinitis, or recurrent nasal bleeding which may, in
the opinion of the investigator, impact on the safety of the subject or the
scientific validity of the study; Nasal biopsy within 60 days of screening; Nasal
jewellery or piercings which could impact nasal safety or airway resistance; Rhinitis
medicamentosa within 60 days of screening; History of glaucoma, cataracts or raised
intraocular pressure.
- Concomitant medications: Use of intranasal corticosteroids (FF, MF or others) within
4 weeks of study participation; Recent or ongoing use of a corticosteroid by a
non-nasal route which, in the opinion of the investigator, could preclude subject
participation in the study; Use of intranasal medications (including intranasal
antihistamines, intranasal decongestants, intranasal saline) within 1 week of study
participation; Use of medications which, in the opinion of the investigator, could
disturb the taste or smell faculties of the subject; Use of any medications that
significantly inhibit the cytochrome P450 (CYP) sub-family CYP3A4, including but not
limited to ritonavir and ketoconazole, within 4 weeks of study participation.
- Relevant habits: Use of perfume or strong-smelling cosmetic products or oral rinse or
similar products on the study day that could, in the opinion of the investigator,
compromise participation in the study. Subjects should be notified of this criterion
prior to study participation; Use of tobacco, or inhaled or oral nicotine-containing
products, is not allowed for 12 hours prior to the start of dosing.
- Contraindications: History of sensitivity to any of the study procedures or
medications, or components thereof, or a history of drug or other allergy that, in
the opinion of the investigator or Medical Monitor, contraindicates their
participation.
- Diagnostic assessments and other criteria: Positive pregnancy test or female who is
breastfeeding; 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), unless more
stringent local guidelines need to be followed.
Locations and Contacts
GSK Investigational Site, Buenos Aires C1425BEN, Argentina
GSK Investigational Site, Ciudad Autónoma de Buenos Aires C1426ABP, Argentina
GSK Investigational Site, Mendoza 5500, Argentina
GSK Investigational Site, Mendoza M5500CCG, Argentina
GSK Investigational Site, Incheon 405-760, Korea, Republic of
GSK Investigational Site, Seongnam-si, Gyeonggi-do 463-707, Korea, Republic of
GSK Investigational Site, Seoul 152-703, Korea, Republic of
GSK Investigational Site, Moscow 123182, Russian Federation
GSK Investigational Site, Stavropol 355030, Russian Federation
GSK Investigational Site, Coffs Harbour, New South Wales 2450, Australia
GSK Investigational Site, Maroubra, New South Wales 2035, Australia
GSK Investigational Site, Murdoch, Western Australia 6150, Australia
Additional Information
Related publications: Meltzer EO, Bardelas J, Goldsobel A, Kaiser H. A preference evaluation study comparing the sensory attributes of mometasone furoate and fluticasone propionate nasal sprays by patients with allergic rhinitis. Treat Respir Med. 2005;4(4):289-96. Sher ER, Ross JA. Intranasal corticosteroids: the role of patient preference and satisfaction. Allergy Asthma Proc. 2014 Jan-Feb;35(1):24-33. doi: 10.2500/aap.2014.35.3725. Review. Meltzer EO, Stahlman JE, Leflein J, Meltzer S, Lim J, Dalal AA, Prillaman BA, Philpot EE. Preferences of adult patients with allergic rhinitis for the sensory attributes of fluticasone furoate versus fluticasone propionate nasal sprays: a randomized, multicenter, double-blind, single-dose, crossover study. Clin Ther. 2008 Feb;30(2):271-9. doi: 10.1016/j.clinthera.2008.02.005.
Starting date: March 2015
Last updated: July 23, 2015
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