Clinical trial NCT02397915
Conditions: Rhinitis, Allergic, Perennial and Seasonal
Keywords: Nasal Spray Fluticasone Furoate Attributes Single Dose Allergic Rhinitis Mometasone Furoate Questionnaire Preference
Sponsor: GlaxoSmithKline
Start date: 2015-03-26; Completion date: 2015-06-08
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief 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.

Detailed description:

Arms: arm 1: Subjects will receive a single dose of intranasal FF (total dose of 110 mcg) as 2 sprays per nostril / 4 sprays in total. arm 2: Subjects will receive a single dose of intranasal MF (total dose of 200 mcg) nasal spray as 2 sprays per nostril / 4 sprays in total.
Interventions: intervention 1: FF nasal spray intervention 2: MF nasal spray
Intervention descriptions: intervention 1: 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. intervention 2: 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.

Protocol documents: