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
Study type: Interventional
Phase: Phase 4

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.
    


Intervention name(s): FF nasal spray; MF nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Nasal Spray; Fluticasone Furoate; Attributes; Single Dose; Allergic Rhinitis; Mometasone Furoate; Questionnaire; Preference