Rhinitis, Allergic, Perennial and Seasonal
Conditions
Keywords
Nasal Spray, Fluticasone Furoate, Attributes, Single Dose, Allergic Rhinitis, Mometasone Furoate, Questionnaire, Preference
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.
Interventions
DRUGFF nasal spray
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.
DRUGMF nasal spray
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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | Approximately four minutes after the administration of the second treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Immediately following each treatment in Period 1 and 2 | 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. |
| Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Immediately following each treatment in Period 1 and 2 | 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. |
| Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Immediately following each treatment in Period 1 and 2 | 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. |
| Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Immediately following each treatment in Period 1 and 2 | 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. |
| Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Immediately following each treatment in Period 1 and 2 | 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. |
| Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Immediately following each treatment in Period 1 and 2 | 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. |
| Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Immediately following each treatment in Period 1 and 2 | 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. |
| Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Immediately following each treatment in Period 1 and 2 | 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. |
| Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Immediately following each treatment in Period 1 and 2 | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
| Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Approximately four minutes after the administration of the second treatment | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
| Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Approximatly two minutes after the dosing in Period 1 and 2 | 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. |
Countries
Argentina, Australia, Russia, South Korea
Participant flow
Recruitment details
This was a single-dose, cross-over participant (par.) preference study, where participants with seasonal allergic rhinitis or perennial allergic rhinitis were randomized, in ratio of 1:1, to receive fluticasone furoate (FF) nasal spray and mometasone furoate (MF) nasal spray.
Participants by arm
| Arm | Count |
|---|---|
| FF 110 µg /MF 200 µg or MF 200 µg /FF 110 µg All participants received treatments in one of two treatment sequences, Sequence 1: two sprays of FF (total of 110 µg) in each nostril (total 4 sprays) in Period 1 and two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) in Period 2; Sequence 2: FF (110 µg) followed by MF (total of 200 µg) and MF (total of 200 µg) followed by FF (110 µg) in Period 2. Two study treatments were administered 30 minutes (+/-5) apart by a third party administrator using a metered nasal spray. | 300 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Period 1 | Physician Decision | 1 | 0 | 0 | 0 |
| Period 1 | Protocol Violation | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | FF 110 µg /MF 200 µg or MF 200 µg /FF 110 µg |
|---|---|
| Age, Continuous | 40.4 Years STANDARD_DEVIATION 13.64 |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 49 Participants |
| Race/Ethnicity, Customized Asian - Mixed Race | 7 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 19 Participants |
| Race/Ethnicity, Customized Mixed Race | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 2 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 217 Participants |
| Sex: Female, Male Female | 185 Participants |
| Sex: Female, Male Male | 115 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 298 | 5 / 298 |
| serious Total, serious adverse events | 0 / 298 | 0 / 298 |
Outcome results
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.
Time frame: Approximately four minutes after the administration of the second treatment
Population: Per Protocol (PP) Population: comprised of all participants who completed both treatment Periods and the questionnaires associated with them.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | FF 110 µg | 96 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | MF 200 µg | 30 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | No preference | 12 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | FF 110 µg | 59 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | MF 200 µg | 57 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire. | No preference | 22 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Mild | 13 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Moderately strong | 1 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Very mild | 42 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Very strong | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Neither mild nor strong | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Slightly strong | 1 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | No | 217 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Slightly strong | 7 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | No | 185 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Very mild | 61 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Mild | 17 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Neither mild nor strong | 4 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Moderately strong | 2 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste. | Very strong | 0 Participants |
p-value: 0.004Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population. Only participants responded to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Slightly | 14 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Moderately | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Very slightly | 36 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Neither slightly nor moderately | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Markedly | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Very markedly | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | None | 19 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Very markedly | 0 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | None | 11 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Very slightly | 51 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Slightly | 26 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Neither slightly nor moderately | 5 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Markedly | 1 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation. | Moderately | 9 Participants |
p-value: 0.007Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Somewhat likely | 37 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Somewhat unlikely | 5 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Moderately unlikely | 4 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Very unlikely | 9 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Moderately likely | 51 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Neither likely nor unlikely | 19 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Very likely | 151 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Moderately unlikely | 5 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Very likely | 128 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Moderately likely | 67 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Somewhat likely | 50 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Neither likely nor unlikely | 13 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Very unlikely | 2 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed | Somewhat unlikely | 11 Participants |
p-value: 0.951Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Slightly | 24 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Very slightly | 57 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Moderately | 3 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Neither slightly nor moderately | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Markedly | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Very markedly | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | None | 188 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Very markedly | 1 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Very slightly | 73 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Neither slightly nor moderately | 5 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Markedly | 5 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | None | 147 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Slightly | 33 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat. | Moderately | 12 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | None | 211 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Very slight | 45 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Slight | 16 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Neither slight nor moderate | 3 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Marked | 1 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Moderately | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Very marked | 0 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Moderately | 6 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | None | 172 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Marked | 4 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Very marked | 0 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Slight | 26 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Very slight | 60 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation. | Neither slight nor moderate | 8 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population. Only participants responded to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Somewhat satisfied | 11 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Somewhat dissatisfied | 1 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Moderately satisfied | 25 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Moderately dissatisfied | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Neither satisfied nor dissatisfied | 19 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Very dissatisfied | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Very satisfied | 150 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Very dissatisfied | 2 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Very satisfied | 151 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Moderately satisfied | 28 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Somewhat satisfied | 12 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Neither satisfied nor dissatisfied | 25 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Somewhat dissatisfied | 2 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor. | Moderately dissatisfied | 1 Participants |
p-value: 0.951Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population. Only participants responded to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Very satisfied | 20 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Moderately satisfied | 13 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Neither satisfied nor dissatisfied | 13 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Somewhat dissatisfied | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Moderately dissatisfied | 3 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Very dissatisfied | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Somewhat satisfied | 11 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Moderately satisfied | 22 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Very satisfied | 18 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Moderately dissatisfied | 4 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Somewhat satisfied | 12 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Somewhat dissatisfied | 10 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Neither satisfied nor dissatisfied | 25 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste. | Very dissatisfied | 1 Participants |
p-value: 0.223Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Very satisfied | 104 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Moderately satisfied | 66 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Somewhat satisfied | 43 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Neither satisfied nor dissatisfied | 44 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Somewhat dissatisfied | 11 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Very dissatisfied | 5 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Moderately dissatisfied | 3 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Neither satisfied nor dissatisfied | 45 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Very satisfied | 75 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Very dissatisfied | 3 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Moderately satisfied | 83 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Somewhat dissatisfied | 12 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Somewhat satisfied | 52 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product. | Moderately dissatisfied | 6 Participants |
p-value: 0.568Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population. Only participants responded to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Very satisfied | 19 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Somewhat dissatisfied | 3 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Moderately dissatisfied | 1 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Very dissatisfied | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Moderately satisfied | 18 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Somewhat satisfied | 9 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Neither satisfied nor dissatisfied | 15 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Neither satisfied nor dissatisfied | 14 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Very satisfied | 13 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Moderately satisfied | 16 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Very dissatisfied | 0 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Somewhat dissatisfied | 4 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Somewhat satisfied | 7 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor. | Moderately dissatisfied | 2 Participants |
p-value: 0.951Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Very mild | 48 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Moderately strong | 1 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Neither mild nor strong | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Very strong | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Mild | 15 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | None | 209 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Slightly strong | 3 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Very mild | 36 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Mild | 12 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Neither mild nor strong | 4 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Slightly strong | 3 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Moderately strong | 1 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | Very strong | 0 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor. | None | 220 Participants |
p-value: 0.951Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | None | 186 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Slightly | 16 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Neither slightly nor moderately | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Moderately | 4 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Very slightly | 68 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Markedly | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Very markedly | 0 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Very markedly | 0 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | None | 165 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Markedly | 1 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Slightly | 30 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Very slightly | 69 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Neither slightly nor moderately | 4 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose. | Moderately | 7 Participants |
p-value: 0.008Cochran-Mantel-Haenszel
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.
Time frame: Approximatly two minutes after the dosing in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Neither slightly nor moderately | 29 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Markedly | 29 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Very markedly | 14 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Very slightly | 53 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Slightly | 48 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Moderately | 38 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | None | 65 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Markedly | 19 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | None | 62 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Very slightly | 65 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Neither slightly nor moderately | 28 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Moderately | 46 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Very markedly | 9 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Delayed Attributes Question Regarding Soothing. | Slightly | 47 Participants |
p-value: 0.831Cochran-Mantel-Haenszel
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.
Time frame: Immediately following each treatment in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Neither mild nor strong | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Very strong | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Mild | 9 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | No | 226 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Slightly strong | 4 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Moderately strong | 3 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Very mild | 34 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Slightly strong | 10 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Mild | 20 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Neither mild nor strong | 0 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Moderately strong | 0 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Very strong | 1 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | No | 205 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste. | Very mild | 40 Participants |
p-value: 0.179Cochran-Mantel-Haenszel
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.
Time frame: Immediately following each treatment in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Slightly | 15 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Moderately | 4 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Very slightly | 56 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Markedly | 1 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Neither slightly nor moderately | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Very markedly | 1 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | None | 197 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Very markedly | 2 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | None | 158 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Very slightly | 64 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Slightly | 33 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Neither slightly nor moderately | 5 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Moderately | 10 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat | Markedly | 4 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
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.
Time frame: Immediately following each treatment in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | None | 169 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Very slightly | 80 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Slightly | 21 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Neither slightly nor moderately | 3 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Moderately | 3 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Markedly | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Very markedly | 0 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Moderately | 12 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | None | 147 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Neither slightly nor moderately | 6 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Very slightly | 75 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Very markedly | 2 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Slightly | 29 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose. | Markedly | 5 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
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.
Time frame: Immediately following each treatment in Period 1 and 2
Population: PP Population. Only participants responded to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Very satisfied | 135 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Neither satisfied nor dissatisfied | 16 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Somewhat satisfied | 7 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Somewhat dissatisfied | 1 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Moderately dissatisfied | 3 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Very dissatisfied | 1 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Moderately satisfied | 19 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Very dissatisfied | 1 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Moderately satisfied | 19 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Somewhat satisfied | 8 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Somewhat dissatisfied | 3 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Moderately dissatisfied | 2 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Neither satisfied nor dissatisfied | 21 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor | Very satisfied | 132 Participants |
p-value: 1Cochran-Mantel-Haenszel
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.
Time frame: Immediately following each treatment in Period 1 and 2
Population: PP Population. Only participants responded to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Very satisfied | 14 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Somewhat satisfied | 5 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Somewhat dissatisfied | 3 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Neither satisfied nor dissatisfied | 10 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Category title 6. Moderately dissatisfied | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Very dissatisfied | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Moderately satisfied | 14 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Neither satisfied nor dissatisfied | 22 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Very satisfied | 16 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Moderately satisfied | 11 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Very dissatisfied | 2 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Category title 6. Moderately dissatisfied | 5 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Somewhat satisfied | 10 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste. | Somewhat dissatisfied | 5 Participants |
p-value: 1Cochran-Mantel-Haenszel
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.
Time frame: Immediately following each treatment in Period 1 and 2
Population: PP Population. Only participants responded to the question were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Somewhat satisfied | 10 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Somewhat dissatisfied | 7 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Moderately satisfied | 19 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Moderately dissatisfied | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Neither satisfied nor dissatisfied | 27 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Very dissatisfied | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Very satisfied | 29 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Very dissatisfied | 2 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Very satisfied | 24 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Moderately satisfied | 27 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Somewhat satisfied | 14 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Neither satisfied nor dissatisfied | 17 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Somewhat dissatisfied | 3 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor | Moderately dissatisfied | 4 Participants |
p-value: 1Cochran-Mantel-Haenszel
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.
Time frame: Immediately following each treatment in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Slightly strong | 8 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Neither mild nor strong | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | None | 180 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Moderately strong | 2 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Mild | 24 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Very strong | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Very mild | 60 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Very strong | 0 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Neither mild nor strong | 2 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | None | 185 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Mild | 16 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Slightly strong | 11 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Moderately strong | 3 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor | Very mild | 59 Participants |
p-value: 1Cochran-Mantel-Haenszel
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.
Time frame: Immediately following each treatment in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Neither slightly nor moderately urgency | 1 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Very slightly urgency | 13 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Slightly urgency | 8 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Markedly urgency | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Moderately urgency | 5 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Very markedly urgency | 0 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | No urgency | 249 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Very markedly urgency | 1 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | No urgency | 233 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Very slightly urgency | 21 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Slightly urgency | 12 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Moderately urgency | 6 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Markedly urgency | 2 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing | Neither slightly nor moderately urgency | 1 Participants |
p-value: 0.188Cochran-Mantel-Haenszel
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.
Time frame: Immediately following each treatment in Period 1 and 2
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Slightly | 49 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Moderately | 34 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Very slightly | 62 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Markedly | 29 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Neither slightly nor moderately | 30 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Very markedly | 13 Participants |
| FF 110 µg /MF 200 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | None | 59 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Very markedly | 11 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | None | 67 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Very slightly | 65 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Slightly | 41 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Neither slightly nor moderately | 28 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Moderately | 41 Participants |
| MF 200 µg /FF 110 µg | Number of Participants Responding to the Immediate Attributes Question Regarding Soothing | Markedly | 23 Participants |
p-value: 1Cochran-Mantel-Haenszel
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.
Time frame: Approximately four minutes after the administration of the second treatment
Population: PP Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Less irritating, no preference | 58 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Scent/odor, no preference | 64 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Immediate taste, FF110 µg | 35 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | After taste, FF110 µg | 41 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | After taste, no preference | 76 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LDTT, no preference | 58 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LRON, no preference | 56 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | UTS, MF 200 µg | 19 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | UTS, no preference | 100 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Scent/odor, FF110 µg | 53 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Scent/odor, MF 200 µg | 21 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Immediate taste, MF 200 µg | 22 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Immediate taste, no preference | 81 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | After taste, MF 200 µg | 21 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LDTT, FF110 µg | 65 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LDTT, MF 200 µg | 15 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LRON, FF110 µg | 60 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LRON, MF 200 µg | 22 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | More soothing, FF110 µg | 68 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | More soothing, MF 200 µg | 35 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | More soothing, no preference | 35 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Less irritating, FF110 µg | 68 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Less irritating, MF 200 µg | 12 Participants |
| FF 110 µg /MF 200 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | UTS, FF110 µg | 19 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LRON, no preference | 67 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | After taste, FF110 µg | 28 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Less irritating, no preference | 68 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Immediate taste, no preference | 86 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | After taste, no preference | 82 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | After taste, MF 200 µg | 28 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | More soothing, FF110 µg | 53 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LDTT, FF110 µg | 37 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LDTT, no preference | 65 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Less irritating, FF110 µg | 37 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | More soothing, no preference | 38 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Less irritating, MF 200 µg | 33 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Scent/odor, MF 200 µg | 31 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | UTS, FF110 µg | 22 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LDTT, MF 200 µg | 36 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | UTS, MF 200 µg | 17 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | More soothing, MF 200 µg | 47 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LRON, FF110 µg | 34 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Scent/odor, FF110 µg | 28 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | UTS, no preference | 99 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Scent/odor, no preference | 79 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Immediate taste, FF110 µg | 25 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | LRON, MF 200 µg | 37 Participants |
| MF 200 µg /FF 110 µg | Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire | Immediate taste, MF 200 µg | 27 Participants |
p-value: 0.065Cochran-Mantel-Haenszel
p-value: 0.532Cochran-Mantel-Haenszel
p-value: 0.138Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: 0.017Cochran-Mantel-Haenszel
p-value: 0.046Cochran-Mantel-Haenszel
p-value: <0.001Cochran-Mantel-Haenszel
p-value: 0.532Cochran-Mantel-Haenszel