Trial Outcomes & Findings for Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays (NCT NCT02397915)
NCT ID: NCT02397915
Last Updated: 2018-01-09
Results Overview
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.
COMPLETED
PHASE4
300 participants
Approximately four minutes after the administration of the second treatment
2018-01-09
Participant Flow
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.
Participant milestones
| Measure |
Period 1: FF 110 µg
Participants received two sprays of FF (total dose of 110 micrograms \[µg\]) in each nostril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
Period 1: MF 200 µg
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
Period 2: MF 200 µg
Participants received two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays).
|
Period 2: FF 110 µg
Participants received FF (total dose of 110 µg) in each nostril (total 4 sprays).
|
|---|---|---|---|---|
|
Period 1
STARTED
|
150
|
150
|
0
|
0
|
|
Period 1
COMPLETED
|
149
|
149
|
0
|
0
|
|
Period 1
NOT COMPLETED
|
1
|
1
|
0
|
0
|
|
Period 2
STARTED
|
0
|
0
|
149
|
149
|
|
Period 2
COMPLETED
|
0
|
0
|
149
|
149
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Period 1: FF 110 µg
Participants received two sprays of FF (total dose of 110 micrograms \[µg\]) in each nostril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
Period 1: MF 200 µg
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
Period 2: MF 200 µg
Participants received two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays).
|
Period 2: FF 110 µg
Participants received FF (total dose of 110 µg) in each nostril (total 4 sprays).
|
|---|---|---|---|---|
|
Period 1
Protocol Violation
|
0
|
1
|
0
|
0
|
|
Period 1
Physician Decision
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays
Baseline characteristics by cohort
| Measure |
FF 110 µg /MF 200 µg or MF 200 µg /FF 110 µg
n=300 Participants
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.
|
|---|---|
|
Age, Continuous
|
40.4 Years
STANDARD_DEVIATION 13.64 • n=5 Participants
|
|
Sex: Female, Male
Female
|
185 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - East Asian Heritage
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - South East Asian Heritage
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian - Mixed Race
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - Arabic/North African Heritage
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
217 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately four minutes after the administration of the second treatmentPopulation: Per Protocol (PP) Population: comprised of all participants who completed both treatment Periods and the questionnaires associated with them.
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=138 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=138 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.
No preference
|
12 Participants
|
22 Participants
|
|
Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.
FF 110 µg
|
96 Participants
|
59 Participants
|
|
Number of Participants With Overall Preference for Nasal Spray Assessed by Preference Questionnaire.
MF 200 µg
|
30 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Approximately four minutes after the administration of the second treatmentPopulation: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=138 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=138 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
Scent/odor, FF110 µg
|
53 Participants
|
28 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
Scent/odor, MF 200 µg
|
21 Participants
|
31 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
Scent/odor, no preference
|
64 Participants
|
79 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
Immediate taste, FF110 µg
|
35 Participants
|
25 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
Immediate taste, MF 200 µg
|
22 Participants
|
27 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
Immediate taste, no preference
|
81 Participants
|
86 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
After taste, FF110 µg
|
41 Participants
|
28 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
After taste, MF 200 µg
|
21 Participants
|
28 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
After taste, no preference
|
76 Participants
|
82 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
LDTT, FF110 µg
|
65 Participants
|
37 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
LDTT, MF 200 µg
|
15 Participants
|
36 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
LDTT, no preference
|
58 Participants
|
65 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
LRON, FF110 µg
|
60 Participants
|
34 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
LRON, MF 200 µg
|
22 Participants
|
37 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
LRON, no preference
|
56 Participants
|
67 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
More soothing, FF110 µg
|
68 Participants
|
53 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
More soothing, MF 200 µg
|
35 Participants
|
47 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
More soothing, no preference
|
35 Participants
|
38 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
Less irritating, FF110 µg
|
68 Participants
|
37 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
Less irritating, MF 200 µg
|
12 Participants
|
33 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
Less irritating, no preference
|
58 Participants
|
68 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
UTS, FF110 µg
|
19 Participants
|
22 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
UTS, MF 200 µg
|
19 Participants
|
17 Participants
|
|
Number of Participants With Preference for Individual Nasal Spray Attributes Assessed by Preference Questionnaire
UTS, no preference
|
100 Participants
|
99 Participants
|
SECONDARY outcome
Timeframe: Immediately following each treatment in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor
None
|
180 Participants
|
185 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor
Very mild
|
60 Participants
|
59 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor
Mild
|
24 Participants
|
16 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor
Neither mild nor strong
|
2 Participants
|
2 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor
Slightly strong
|
8 Participants
|
11 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor
Moderately strong
|
2 Participants
|
3 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Scent/Odor
Very strong
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Immediately following each treatment in Period 1 and 2Population: PP Population. Only participants responded to the question were analyzed.
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=96 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=91 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor
Very satisfied
|
29 Participants
|
24 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor
Moderately satisfied
|
19 Participants
|
27 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor
Somewhat satisfied
|
10 Participants
|
14 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor
Neither satisfied nor dissatisfied
|
27 Participants
|
17 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor
Somewhat dissatisfied
|
7 Participants
|
3 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor
Moderately dissatisfied
|
2 Participants
|
4 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Scent/Odor
Very dissatisfied
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Immediately following each treatment in Period 1 and 2Population: PP Population. Only participants responded to the question were analyzed.
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=182 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=186 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor
Very satisfied
|
135 Participants
|
132 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor
Moderately satisfied
|
19 Participants
|
19 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor
Somewhat satisfied
|
7 Participants
|
8 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor
Neither satisfied nor dissatisfied
|
16 Participants
|
21 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor
Somewhat dissatisfied
|
1 Participants
|
3 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor
Moderately dissatisfied
|
3 Participants
|
2 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction Not to Have Scent/Odor
Very dissatisfied
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immediately following each treatment in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.
Very mild
|
34 Participants
|
40 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.
No
|
226 Participants
|
205 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.
Mild
|
9 Participants
|
20 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.
Neither mild nor strong
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.
Slightly strong
|
4 Participants
|
10 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.
Moderately strong
|
3 Participants
|
0 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Immediate Taste.
Very strong
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Immediately following each treatment in Period 1 and 2Population: PP Population. Only participants responded to the question were analyzed.
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=50 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=71 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.
Very satisfied
|
14 Participants
|
16 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.
Moderately satisfied
|
14 Participants
|
11 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.
Somewhat satisfied
|
5 Participants
|
10 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.
Neither satisfied nor dissatisfied
|
10 Participants
|
22 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.
Somewhat dissatisfied
|
3 Participants
|
5 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.
Category title 6. Moderately dissatisfied
|
2 Participants
|
5 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Satisfaction With Immediate Taste.
Very dissatisfied
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Immediately following each treatment in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat
None
|
197 Participants
|
158 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat
Very slightly
|
56 Participants
|
64 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat
Slightly
|
15 Participants
|
33 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat
Neither slightly nor moderately
|
2 Participants
|
5 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat
Moderately
|
4 Participants
|
10 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat
Markedly
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Down Throat
Very markedly
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Immediately following each treatment in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.
None
|
169 Participants
|
147 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.
Very slightly
|
80 Participants
|
75 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.
Slightly
|
21 Participants
|
29 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.
Neither slightly nor moderately
|
3 Participants
|
6 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.
Moderately
|
3 Participants
|
12 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.
Markedly
|
0 Participants
|
5 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Medicine Running Out of Nose.
Very markedly
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Immediately following each treatment in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Soothing
Moderately
|
34 Participants
|
41 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Soothing
Markedly
|
29 Participants
|
23 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Soothing
Very markedly
|
13 Participants
|
11 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Soothing
None
|
59 Participants
|
67 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Soothing
Very slightly
|
62 Participants
|
65 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Soothing
Slightly
|
49 Participants
|
41 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Soothing
Neither slightly nor moderately
|
30 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: Immediately following each treatment in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing
No urgency
|
249 Participants
|
233 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing
Very slightly urgency
|
13 Participants
|
21 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing
Slightly urgency
|
8 Participants
|
12 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing
Neither slightly nor moderately urgency
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing
Moderately urgency
|
5 Participants
|
6 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing
Markedly urgency
|
0 Participants
|
2 Participants
|
|
Number of Participants Responding to the Immediate Attributes Question Regarding Sneezing
Very markedly urgency
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.
None
|
209 Participants
|
220 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.
Very mild
|
48 Participants
|
36 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.
Mild
|
15 Participants
|
12 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.
Neither mild nor strong
|
0 Participants
|
4 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.
Slightly strong
|
3 Participants
|
3 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.
Moderately strong
|
1 Participants
|
1 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Scent/Odor.
Very strong
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population. Only participants responded to the question were analyzed.
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=67 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=56 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.
Very satisfied
|
19 Participants
|
13 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.
Moderately satisfied
|
18 Participants
|
16 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.
Somewhat satisfied
|
9 Participants
|
7 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.
Neither satisfied nor dissatisfied
|
15 Participants
|
14 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.
Somewhat dissatisfied
|
3 Participants
|
4 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.
Moderately dissatisfied
|
1 Participants
|
2 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Scent/Odor.
Very dissatisfied
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population. Only participants responded to the question were analyzed.
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=210 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=221 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.
Very satisfied
|
150 Participants
|
151 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.
Moderately satisfied
|
25 Participants
|
28 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.
Somewhat satisfied
|
11 Participants
|
12 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.
Neither satisfied nor dissatisfied
|
19 Participants
|
25 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.
Somewhat dissatisfied
|
1 Participants
|
2 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.
Moderately dissatisfied
|
2 Participants
|
1 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction Not to Have Scent/Odor.
Very dissatisfied
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.
No
|
217 Participants
|
185 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.
Very mild
|
42 Participants
|
61 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.
Mild
|
13 Participants
|
17 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.
Neither mild nor strong
|
2 Participants
|
4 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.
Slightly strong
|
1 Participants
|
7 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.
Moderately strong
|
1 Participants
|
2 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Aftertaste.
Very strong
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population. Only participants responded to the question were analyzed.
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=62 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=92 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.
Very satisfied
|
20 Participants
|
18 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.
Moderately satisfied
|
13 Participants
|
22 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.
Somewhat satisfied
|
11 Participants
|
12 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.
Neither satisfied nor dissatisfied
|
13 Participants
|
25 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.
Somewhat dissatisfied
|
2 Participants
|
10 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.
Moderately dissatisfied
|
3 Participants
|
4 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Aftertaste.
Very dissatisfied
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.
None
|
188 Participants
|
147 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.
Very slightly
|
57 Participants
|
73 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.
Slightly
|
24 Participants
|
33 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.
Neither slightly nor moderately
|
2 Participants
|
5 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.
Moderately
|
3 Participants
|
12 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.
Markedly
|
2 Participants
|
5 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Medicine Running Down Throat.
Very markedly
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.
None
|
186 Participants
|
165 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.
Very slightly
|
68 Participants
|
69 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.
Slightly
|
16 Participants
|
30 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.
Neither slightly nor moderately
|
2 Participants
|
4 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.
Moderately
|
4 Participants
|
7 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.
Markedly
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Smedicine Running Out of Nose.
Very markedly
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.
Markedly
|
29 Participants
|
19 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.
None
|
65 Participants
|
62 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.
Very slightly
|
53 Participants
|
65 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.
Slightly
|
48 Participants
|
47 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.
Neither slightly nor moderately
|
29 Participants
|
28 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.
Moderately
|
38 Participants
|
46 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Soothing.
Very markedly
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.
Moderately
|
0 Participants
|
6 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.
Marked
|
1 Participants
|
4 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.
Very marked
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.
Very slight
|
45 Participants
|
60 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.
Slight
|
16 Participants
|
26 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.
Neither slight nor moderate
|
3 Participants
|
8 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Nasal Irritation.
None
|
211 Participants
|
172 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population. Only participants responded to the question were analyzed.
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=71 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=103 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.
None
|
19 Participants
|
11 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.
Markedly
|
0 Participants
|
1 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.
Very slightly
|
36 Participants
|
51 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.
Slightly
|
14 Participants
|
26 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.
Neither slightly nor moderately
|
2 Participants
|
5 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.
Very markedly
|
0 Participants
|
0 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Bothersome Nasal Irritation.
Moderately
|
0 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.
Very satisfied
|
104 Participants
|
75 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.
Moderately satisfied
|
66 Participants
|
83 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.
Somewhat dissatisfied
|
11 Participants
|
12 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.
Moderately dissatisfied
|
3 Participants
|
6 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.
Very dissatisfied
|
5 Participants
|
3 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.
Somewhat satisfied
|
43 Participants
|
52 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Satisfaction With Product.
Neither satisfied nor dissatisfied
|
44 Participants
|
45 Participants
|
SECONDARY outcome
Timeframe: Approximatly two minutes after the dosing in Period 1 and 2Population: PP Population
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.
Outcome measures
| Measure |
FF 110 µg /MF 200 µg
n=276 Participants
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
MF 200 µg /FF 110 µg
n=276 Participants
Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
|
|---|---|---|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed
Moderately likely
|
51 Participants
|
67 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed
Neither likely nor unlikely
|
19 Participants
|
13 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed
Somewhat unlikely
|
5 Participants
|
11 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed
Moderately unlikely
|
4 Participants
|
5 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed
Very likely
|
151 Participants
|
128 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed
Somewhat likely
|
37 Participants
|
50 Participants
|
|
Number of Participants Responding to the Delayed Attributes Question Regarding Likeliness to Comply if Prescribed
Very unlikely
|
9 Participants
|
2 Participants
|
Adverse Events
FF 110 µg
MF 200 µg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FF 110 µg
n=298 participants at risk
Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
|
MF 200 µg
n=298 participants at risk
Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.34%
1/298 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment until the follow-up contact (up to 96 hours).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who were randomized to treatment.
|
1.3%
4/298 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment until the follow-up contact (up to 96 hours).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who were randomized to treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/298 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment until the follow-up contact (up to 96 hours).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who were randomized to treatment.
|
1.0%
3/298 • On-treatment serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from start of study treatment until the follow-up contact (up to 96 hours).
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who were randomized to treatment.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER