Patient Preference Study of Fluticasone Furoate and Momet... | NCT02397915

Label	Type	Description	Intervention Names
Fluticasone Furoate	Experimental	Subjects will receive a single dose of intranasal FF (total dose of 110 mcg) as 2 sprays per nostril / 4 sprays in total.	Drug: FF nasal spray
Mometasone Furoate	Experimental	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.	Drug: MF nasal spray

Name	Type	Description	Arm Group Labels	Other Names
FF nasal spray	Drug	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.

Measure	Description	Time Frame
Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.	An overall preference questionnaire (OPQ) was used to evaluate participants' preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment in Period 2. Overall participant preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg's method.	Approximately four minutes after the administration of the second treatment

Measure	Description	Time Frame
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire	An overall preference questionnaire (OPQ) was used to evaluate participants' attribute preference for nasal spray therapy for the given treatment. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. Products attributes included scent/odor, immediate taste, after taste, less drip through throat (LDTT), less run out of nose (LRON), more soothing, less irritating and urge to sneeze (UTS). The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment (tmt) in Period 2. Overall participant preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country (ctry) and symptomatology (sym). All preference p-values were also adjusted for multiplicity using Hochberg's method.

Eligibility Module

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.

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Buenos Aires		C1425BEN	Argentina
GSK Investigational Site

PubMed Identifier	Type	Citation	Retractions
16086602	Background	Meltzer EO, Bardelas J, Goldsobel A, Kaiser H. A preference evaluation study comparing the sensory attributes of mometasone furoate and fluticasone propionate nasal sprays by patients with allergic rhinitis. Treat Respir Med. 2005;4(4):289-96. doi: 10.2165/00151829-200504040-00007.
18343265	Background	Meltzer EO, Stahlman JE, Leflein J, Meltzer S, Lim J, Dalal AA, Prillaman BA, Philpot EE. Preferences of adult patients with allergic rhinitis for the sensory attributes of fluticasone furoate versus fluticasone propionate nasal sprays: a randomized, multicenter, double-blind, single-dose, crossover study. Clin Ther. 2008 Feb;30(2):271-9. doi: 10.1016/j.clinthera.2008.02.005.

Label	URL
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.	View source

ID	Type	URL	Comment
201474	Informed Consent Form	View IPD

ID	Title	Description
FG000	Period 1: FF 110 µg	Participants received two sprays of FF (total dose of 110 micrograms [µg]) in each nostril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
FG001	Period 1: MF 200 µg

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.

An overall preference questionnaire (OPQ) was used to evaluate participants' preference for nasal spray therapy for the given treatments. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment in Period 2. Overall participant preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg's method.

Per Protocol (PP) Population: comprised of all participants who completed both treatment Periods and the questionnaires associated with them.

Posted

Number

Participants

Approximately four minutes after the administration of the second treatment

ID	Title	Description
OG000	FF 110 µg /MF 200 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
OG001	MF 200 µg /FF 110 µg	Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.

Units	Counts
Participants	OG000138 OG001138

Title

Denominators

Categories

FF 110 µg

Title	Measurements
	OG00096 OG00159

MF 200 µg

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Cochran-Mantel-Haenszel		<0.001	Par. preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel test, adjusted for country and symptomatology. All preference p-values were also adjusted for multiplicity using Hochberg's method.													Superiority or Other

Secondary

Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire

An overall preference questionnaire (OPQ) was used to evaluate participants' attribute preference for nasal spray therapy for the given treatment. OPQ allows the responder three options, based on products attributes, i.e. preference for product 1; preference for product 2 and no preference. Products attributes included scent/odor, immediate taste, after taste, less drip through throat (LDTT), less run out of nose (LRON), more soothing, less irritating and urge to sneeze (UTS). The OPQ was completed by each participant approximately 4 minutes after administration of the second treatment (tmt) in Period 2. Overall participant preferences were analyzed using Prescott's test, as approximated by a Cochran-Mantel-Haenszel (CMH) test, adjusted for country (ctry) and symptomatology (sym). All preference p-values were also adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Approximately four minutes after the administration of the second treatment

ID	Title	Description
OG000	FF 110 µg /MF 200 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
OG001	MF 200 µg /FF 110 µg

Secondary

Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor

Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 1, "Did product have a scent/odor?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance (ANOVA) mixed model with participant as a random effect, and country, treatment, period, and Baseline (BL) rhinitis symptomatology subgroup (subgrp), and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Immediately following each treatment in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor

Immediate attributes questionnaire (ques) was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes ques, Question 2, "How satisfied with scent/odor?" are summarized. The immediate' attributes ques was completed immediately following each treatment (trt) in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population. Only participants responded to the question were analyzed.

Posted

Number

Participants

Immediately following each treatment in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg

Secondary

Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor

Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using immediate attributes questionnaire, Question 3, "How satisfied not to have scent/odor?" are summarized. The immediate' attributes questionnaire was completed immediately following each trt in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, trt, period, and BL rhinitis symptomatology subgroup, and trt sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population. Only participants responded to the question were analyzed.

Posted

Number

Participants

Immediately following each treatment in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg

Secondary

Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.

Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 4, "Did product have an immediate taste?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Immediately following each treatment in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.

Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using immediate attributes questionnaire, Question 5, "How satisfied with immediate taste?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population. Only participants responded to the question were analyzed.

Posted

Number

Participants

Immediately following each treatment in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg

Secondary

Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat

Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 6, "Did medicine run down throat?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Immediately following each treatment in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.

Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 7, "Did medicine run out of nose?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Immediately following each treatment in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Immediate Attributes Question Regarding Soothing

Immediate attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using immediate attributes questionnaire, Question 8, "Did product feel soothing?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Immediately following each treatment in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing

Immediate attributes questionnaire was used to evaluate immediate ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes using immediate attributes questionnaire, Question 9, "Did product make want to sneeze?" are summarized. The immediate attributes questionnaire was completed immediately following each treatment in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no urgency; 1: very slightly urgency; 2: slightly urgency; 3: neither slightly nor moderately urgency; 4: moderately urgency; 5; markedly urgency; 6: very markedly urgency. Immediate attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of immediate attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Immediately following each treatment in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.

Delayed attributes questionnaire was used to evaluate immediate ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 1, "Did product have a scent/odor?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.

Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 2, "How satisfied with scent/odor?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population. Only participants responded to the question were analyzed.

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.

Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. scent/odor, using delayed attributes questionnaire, Question 3, "How satisfied not to have scent/odor?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population. Only participants responded to the question were analyzed.

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.

Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 4, "Did product have an aftertaste?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very mild; 2: mild; 3: neither mild nor strong; 4: slightly strong; 5; moderately strong; 6: very strong. Immediate attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.

Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 5, "How satisfied with aftertaste?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with par. as a random effect, and country, treatment, period, and BL rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population. Only participants responded to the question were analyzed.

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.

Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 6, "Did medicine run down throat?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.

Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 7, "Did medicine run out of nose?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.

Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 8, "Did product feel soothing?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.

Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 9, "Did product cause nasal irritation?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: no; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.

Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes using delayed attributes questionnaire, Question 10, "How bothersome was nasal irritation?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: none; 1: very slightly; 2: slightly; 3: neither slightly nor moderately; 4: moderately; 5; markedly; 6: very markedly. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population. Only participants responded to the question were analyzed.

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.

Delayed attributes questionnaire was used to evaluate delayed ratings of participant for individual attributes of FF and MF nasal spray. Number of participants responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 11, "How satisfied with product?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Participants specified their responses on a 6-point scale: 0: very satisfied; 1: moderately satisfied; 2: somewhat satisfied; 3: neither satisfied nor dissatisfied; 4: somewhat dissatisfied; 5; moderately dissatisfied; 6: very dissatisfied. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

Secondary

Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed

Delayed attributes questionnaire was used to evaluate delayed ratings of par. for individual attributes of FF and MF nasal spray. Number of par. responding to product attributes i.e. taste, using delayed attributes questionnaire, Question 12, "How likely to comply if prescribed?" are summarized. The delayed attributes questionnaire was completed 2 minutes after dosing, in Period 1 and 2. Par. specified their responses on a 6-point scale: 0: very likely; 1: moderately likely; 2: somewhat likely; 3: neither likely nor unlikely; 4: somewhat unlikely; 5; moderately unlikely; 6: very unlikely. Delayed attribute ratings were analyzed using an analysis of variance mixed model with participant as a random effect, and country, treatment, period, and Baseline rhinitis symptomatology subgroup, and treatment sequence as main effects. P-values associated with tests of delayed attribute rating scores were adjusted for multiplicity using Hochberg's method.

PP Population

Posted

Number

Participants

Approximatly two minutes after the dosing in Period 1 and 2

ID	Title	Description
OG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
OG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	FF 110 µg	Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.			0	298	1	298
EG001	MF 200 µg	Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.			0	298	5	298

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment		EG0001 affected298 at risk EG0014 affected298 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment		EG0000 affected298 at risk EG0013 affected298 at risk

ID	Term
D012220	Rhinitis
D065631	Rhinitis, Allergic

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases
D012130	Respiratory Hypersensitivity
D006969	Hypersensitivity, Immediate
D006967	Hypersensitivity
D007154	Immune System Diseases