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Phase 4 N=300 Randomized Double-blind Other

Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays

Rhinitis, Allergic, Perennial and Seasonal

Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. — 96; 59; 30; 57 Participants — p=<0.001

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
FF nasal spray (Drug); MF nasal spray (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Jun 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.
96; 59; 30; 57; 12; 22 <0.001 sig
SECONDARY
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
53; 28; 21; 31; 64; 79 0.065
SECONDARY
Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor
180; 185; 60; 59; 24; 16 1.000
SECONDARY
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor
29; 24; 19; 27; 10; 14 1.00
SECONDARY
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor
135; 132; 19; 19; 7; 8 1.00
SECONDARY
Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.
226; 205; 34; 40; 9; 20 0.179
SECONDARY
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.
14; 16; 14; 11; 5; 10 1.00
SECONDARY
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat
197; 158; 56; 64; 15; 33 <0.001 sig
SECONDARY
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.
169; 147; 80; 75; 21; 29 <0.001 sig
SECONDARY
Number of Participants Responding to the Immediate Attributes Question Regarding Soothing
59; 67; 62; 65; 49; 41 1.000
SECONDARY
Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing
249; 233; 13; 21; 8; 12 0.188
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.
209; 220; 48; 36; 15; 12 0.951
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.
19; 13; 18; 16; 9; 7 0.951
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.
150; 151; 25; 28; 11; 12 0.951
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.
217; 185; 42; 61; 13; 17 0.004 sig
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.
20; 18; 13; 22; 11; 12 0.223
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.
188; 147; 57; 73; 24; 33 <0.001 sig
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.
186; 165; 68; 69; 16; 30 0.008 sig
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.
65; 62; 53; 65; 48; 47 0.831
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.
211; 172; 45; 60; 16; 26 <0.001 sig
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.
19; 11; 36; 51; 14; 26 0.007 sig
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.
104; 75; 66; 83; 43; 52 0.568
SECONDARY
Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed
151; 128; 51; 67; 37; 50 0.951

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 contracept
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02397915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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