Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays
Status:
Completed
Trial end date:
2015-06-08
Target enrollment:
Participant gender:
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.