Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays
Condition: Rhinitis, Allergic, Perennial and Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Intervention: FF nasal spray; MF nasal spray
Intervention description: FF as a suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose x 4 doses (total dose 110 mcg) administered via a metered side-actuated nasal spray device.; MF as a suspension for intranasal inhalation with unit dose strength of 50 mcg per dose x 4 doses (total dose 200 mcg) administered via a metered top-actuated nasal spray device.
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 300.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Nasal Spray; Fluticasone Furoate; Attributes; Single Dose; Allergic Rhinitis; Mometasone Furoate; Questionnaire; Preference

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.
    

Eligibility 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.