Trial Outcomes & Findings for Fluticasone Nasal Spray Patient Preference Study (NCT NCT00398476)
NCT ID: NCT00398476
Last Updated: 2018-03-01
Results Overview
An overall preference questionnaire (OPQ) was used to evaluate participant's 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 (FF 110 µg); preference for product 2 (FP 200 µg) and no preference. Three participant-related questionnaires were completed during the course of the study, including two attributes questionnaires : Immediate attributes questionnaire (IAQ) and delayed attributes questionnaire (DAQ). An OPQ was completed upon completion of the crossover dosing.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
127 participants
Primary outcome timeframe
Day 1
Results posted on
2018-03-01
Participant Flow
A total of 127 male or eligible female participants with a diagnosis of allergic rhinitis were enrolled in the study. This study was conducted at 12 investigator sites in the United States. Study duration was '01 December 2006 - 04 December 2006'. Participants included in PP population were 121.
Participant milestones
| Measure |
FF 110 µg /FP 200 µg
In this sequence, participants received a single-dose treatment fluticasone furoate (FF) 110 micrograms (µg) in period 1 and fluticasone propionate (FP) 200 µg in period 2 (2 sprays per nostril - 4 sprays in total) for 30 minutes. Each spray of the suspension was containing approximately 27.5 µg of FF and each actuation delivered 50 µg of FP in 100 milligram (mg) of formulation through the nasal adapter. There was a washout period of 20 minutes in between the 2 periods.
|
FP 200 µg /FF 110 µg
In this sequence, participants received a single-dose treatment FP 200 µg in period 1 and FF 110 µg in period 2 (2 sprays per nostril - 4 sprays in total) for 30 minutes. Each spray of the suspension was containing approximately 27.5 µg of FF and Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter. There was a washout period of 20 minutes in between the 2 periods.
|
|---|---|---|
|
Treatment Period 1
STARTED
|
63
|
64
|
|
Treatment Period 1
COMPLETED
|
63
|
64
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
|
Washout Period (20 Minutes)
STARTED
|
63
|
64
|
|
Washout Period (20 Minutes)
COMPLETED
|
63
|
64
|
|
Washout Period (20 Minutes)
NOT COMPLETED
|
0
|
0
|
|
Treatment Period 2
STARTED
|
63
|
64
|
|
Treatment Period 2
COMPLETED
|
63
|
64
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Intent to treat population comprised of all participants who were randomized to treatment with study drug. Where n was 126.
Baseline characteristics by cohort
| Measure |
Overall Study Arm
n=127 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg/FF 110 µg or FF 110 µg/FP 200 µgin a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
|---|---|
|
Age, Continuous
|
39.7 Years
STANDARD_DEVIATION 14.05 • n=127 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=127 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=127 Participants
|
|
Race/Ethnicity, Customized
Race · African American/African Heritage
|
20 Participants
n=126 Participants • Intent to treat population comprised of all participants who were randomized to treatment with study drug. Where n was 126.
|
|
Race/Ethnicity, Customized
Race · Asian - East Asian Heritage
|
1 Participants
n=126 Participants • Intent to treat population comprised of all participants who were randomized to treatment with study drug. Where n was 126.
|
|
Race/Ethnicity, Customized
Race · Asian - South East Asian Heritage
|
1 Participants
n=126 Participants • Intent to treat population comprised of all participants who were randomized to treatment with study drug. Where n was 126.
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or other Pacific Islander
|
1 Participants
n=126 Participants • Intent to treat population comprised of all participants who were randomized to treatment with study drug. Where n was 126.
|
|
Race/Ethnicity, Customized
Race · White - Arabic/North African Heritage
|
1 Participants
n=126 Participants • Intent to treat population comprised of all participants who were randomized to treatment with study drug. Where n was 126.
|
|
Race/Ethnicity, Customized
Race · White - White/Caucasian/European Heritage
|
100 Participants
n=126 Participants • Intent to treat population comprised of all participants who were randomized to treatment with study drug. Where n was 126.
|
|
Race/Ethnicity, Customized
Race · Mixed Race
|
2 Participants
n=126 Participants • Intent to treat population comprised of all participants who were randomized to treatment with study drug. Where n was 126.
|
PRIMARY outcome
Timeframe: Day 1Population: Per Protocol population comprised of all participants who completed both treatment periods. Only those participants available at the indicated time points were analyzed.
An overall preference questionnaire (OPQ) was used to evaluate participant's 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 (FF 110 µg); preference for product 2 (FP 200 µg) and no preference. Three participant-related questionnaires were completed during the course of the study, including two attributes questionnaires : Immediate attributes questionnaire (IAQ) and delayed attributes questionnaire (DAQ). An OPQ was completed upon completion of the crossover dosing.
Outcome measures
| Measure |
Overall Study Arm
n=120 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Scent/odor, FP 200 µg
|
35 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Immediate taste, No preference
|
39 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
After-taste, FF 110 µg
|
53 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
After-taste, FP 200 µg
|
26 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
After-taste, No preference
|
41 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Less drip down throat, FF 110 µg
|
52 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Less drip down throat, FP 200 µg
|
32 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Less drip down throat, No preference
|
36 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Less run out nose, FF 110 µg
|
59 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Less run out nose, FP 200 µg
|
23 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Less run out nose, No preference
|
38 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
More soothing, FF 110 µg
|
45 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
More soothing, FP 200 µg
|
38 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
More soothing, No preference
|
37 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Less irritating, FF 110 µg
|
41 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Less irritating, FP 200 µg
|
26 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Less irritating, No preference
|
53 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Urge to sneeze, FF 110 µg
|
25 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Urge to sneeze, FP 200 µg
|
21 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Urge to sneeze, No preference
|
74 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Overall, FF 110 µg
|
72 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Overall, FP 200 µg
|
39 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Overall, No preference
|
9 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Scent/odor, FF 110 µg
|
77 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Scent/odor, No preference
|
8 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Immediate taste, FF 110 µg
|
56 Participants
|
—
|
|
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
Immediate taste, FP 200 µg
|
25 Participants
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Per Protocol population. Only those participants available at the specified time points were analyzed.
Participant preference for scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product have a scent/odor?. 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. Higher score indicated strong odor.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=121 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
DAQ, Mild
|
16 Participants
|
29 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
IAQ, None
|
62 Participants
|
12 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
DAQ, None
|
71 Participants
|
16 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
IAQ, Very mild
|
27 Participants
|
22 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
DAQ, Very mild
|
21 Participants
|
39 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
IAQ, Mild
|
19 Participants
|
35 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
IAQ, Neither mild nor strong
|
2 Participants
|
7 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
DAQ, Neither mild nor strong
|
4 Participants
|
4 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
IAQ, Slightly strong
|
6 Participants
|
20 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
DAQ, Slightly strong
|
6 Participants
|
20 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
IAQ, Moderately strong
|
4 Participants
|
19 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
DAQ, Moderately strong
|
2 Participants
|
10 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
IAQ, Very strong
|
1 Participants
|
5 Participants
|
|
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
DAQ, Very strong
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the specified time points were analyzed.
Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with scent/odor?. 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.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=121 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
IAQ, Very satisfied
|
11 Participants
|
16 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
IAQ, Moderately satisfied
|
12 Participants
|
20 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
IAQ, Somewhat satisfied
|
13 Participants
|
25 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
IAQ, Neither satisfied nor dissatisfied
|
16 Participants
|
17 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
IAQ, Somewhat dissatisfied
|
6 Participants
|
23 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
IAQ, Moderately dissatisfied
|
1 Participants
|
5 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
IAQ, Very dissatisfied
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the specified time points were analyzed.
Participant preference for Satisfaction scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied with scent/odor?. 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.
Outcome measures
| Measure |
Overall Study Arm
n=53 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=106 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
DAQ, Very satisfied
|
14 Participants
|
19 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
DAQ, Moderately satisfied
|
11 Participants
|
21 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
DAQ, Somewhat satisfied
|
12 Participants
|
20 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
DAQ, Neither satisfied nor dissatisfied
|
10 Participants
|
22 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
DAQ, Somewhat dissatisfied
|
5 Participants
|
16 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
DAQ, Moderately dissatisfied
|
0 Participants
|
6 Participants
|
|
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
DAQ, Very dissatisfied
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the specified time points were analyzed.
Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied not to have scent/odor?. 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.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=121 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
IAQ, Very satisfied
|
46 Participants
|
10 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
IAQ, Moderately satisfied
|
7 Participants
|
2 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
IAQ, Somewhat satisfied
|
1 Participants
|
0 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
IAQ, Neither satisfied nor dissatisfied
|
6 Participants
|
1 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
IAQ, Somewhat dissatisfied
|
2 Participants
|
0 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
IAQ, Moderately dissatisfied
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
IAQ, Very dissatisfied
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the specified time points were analyzed.
Participant preference for participants who satisfied not to have scent/odor at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: How satisfied not to have scent/odor?. 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.
Outcome measures
| Measure |
Overall Study Arm
n=74 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=16 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
DAQ, Somewhat satisfied
|
4 Participants
|
0 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
DAQ, Very satisfied
|
56 Participants
|
14 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
DAQ, Moderately satisfied
|
2 Participants
|
1 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
DAQ, Neither satisfied nor dissatisfied
|
8 Participants
|
1 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
DAQ, Somewhat dissatisfied
|
3 Participants
|
0 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
DAQ, Moderately dissatisfied
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
DAQ, Very dissatisfied
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
Participant preference for an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product have an immediate taste?. Participants specified their responses on a 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.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=121 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Reported Product Have an Immediate Taste in IAQ
No taste
|
98 Participants
|
69 Participants
|
|
Number of Participants Reported Product Have an Immediate Taste in IAQ
Very mild taste
|
10 Participants
|
25 Participants
|
|
Number of Participants Reported Product Have an Immediate Taste in IAQ
Mild taste
|
7 Participants
|
13 Participants
|
|
Number of Participants Reported Product Have an Immediate Taste in IAQ
Neither mild nor strong taste
|
2 Participants
|
6 Participants
|
|
Number of Participants Reported Product Have an Immediate Taste in IAQ
Slightly strong taste
|
3 Participants
|
6 Participants
|
|
Number of Participants Reported Product Have an Immediate Taste in IAQ
Moderately strong taste
|
1 Participants
|
2 Participants
|
|
Number of Participants Reported Product Have an Immediate Taste in IAQ
Very strong taste
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
Participant preference for satisfaction with an immediate taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: How satisfied with immediate taste?. 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.
Outcome measures
| Measure |
Overall Study Arm
n=33 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=54 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Satisfied With an Immediate Taste in IAQ
Very satisfied
|
6 Participants
|
12 Participants
|
|
Number of Participants Satisfied With an Immediate Taste in IAQ
Moderately satisfied
|
7 Participants
|
9 Participants
|
|
Number of Participants Satisfied With an Immediate Taste in IAQ
Somewhat satisfied
|
6 Participants
|
9 Participants
|
|
Number of Participants Satisfied With an Immediate Taste in IAQ
Neither satisfied nor dissatisfied
|
9 Participants
|
15 Participants
|
|
Number of Participants Satisfied With an Immediate Taste in IAQ
Somewhat dissatisfied
|
3 Participants
|
6 Participants
|
|
Number of Participants Satisfied With an Immediate Taste in IAQ
Moderately dissatisfied
|
1 Participants
|
3 Participants
|
|
Number of Participants Satisfied With an Immediate Taste in IAQ
Very dissatisfied
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
Participant response for an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product have an aftertaste?. Participants specified their responses on a 6-point scale: 0: No aftertaste; 1: Very mild; 2: Mild; 3: Neither mild nor strong; 4: Slightly strong; 5: Moderately strong; 6: Very strong.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=121 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Reported Product Have an After Taste in DAQ
No aftertaste
|
90 Participants
|
66 Participants
|
|
Number of Participants Reported Product Have an After Taste in DAQ
Very mild aftertaste
|
22 Participants
|
33 Participants
|
|
Number of Participants Reported Product Have an After Taste in DAQ
Mild aftertaste
|
7 Participants
|
10 Participants
|
|
Number of Participants Reported Product Have an After Taste in DAQ
Neither mild nor strong aftertaste
|
0 Participants
|
3 Participants
|
|
Number of Participants Reported Product Have an After Taste in DAQ
Slightly strong aftertaste
|
2 Participants
|
6 Participants
|
|
Number of Participants Reported Product Have an After Taste in DAQ
Moderately strong aftertaste
|
0 Participants
|
3 Participants
|
|
Number of Participants Reported Product Have an After Taste in DAQ
Very strong aftertaste
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
Participant response for satisfaction with an after taste at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How satisfied with aftertaste? 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.
Outcome measures
| Measure |
Overall Study Arm
n=34 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=54 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Satisfied With an After Taste in DAQ
Very satisfied
|
7 Participants
|
12 Participants
|
|
Number of Participants Satisfied With an After Taste in DAQ
Moderately satisfied
|
8 Participants
|
9 Participants
|
|
Number of Participants Satisfied With an After Taste in DAQ
Somewhat satisfied
|
3 Participants
|
7 Participants
|
|
Number of Participants Satisfied With an After Taste in DAQ
Neither satisfied nor dissatisfied
|
11 Participants
|
15 Participants
|
|
Number of Participants Satisfied With an After Taste in DAQ
Somewhat dissatisfied
|
3 Participants
|
9 Participants
|
|
Number of Participants Satisfied With an After Taste in DAQ
Moderately dissatisfied
|
2 Participants
|
2 Participants
|
|
Number of Participants Satisfied With an After Taste in DAQ
Very dissatisfied
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the specified time points were analyzed.
Participant response regarding did the medicine run down throat at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run down throat? 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.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=121 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
IAQ, None
|
74 Participants
|
69 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
DAQ, None
|
64 Participants
|
55 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
IAQ, Very slightly
|
28 Participants
|
29 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
DAQ, Very slightly
|
36 Participants
|
37 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
IAQ, Slightly
|
11 Participants
|
15 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
DAQ, Slightly
|
12 Participants
|
17 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
IAQ, Neither slightly nor moderately
|
3 Participants
|
5 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
DAQ, Neither slightly nor moderately
|
1 Participants
|
3 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
IAQ, Moderately
|
3 Participants
|
3 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
DAQ, Moderately
|
5 Participants
|
6 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
IAQ, Markedly
|
1 Participants
|
0 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
DAQ, Markedly
|
3 Participants
|
1 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
IAQ, Very markedly
|
1 Participants
|
0 Participants
|
|
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
DAQ, Very markedly
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
Participant response regarding did the medicine run out of nose at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did medicine run out of nose? 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.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=121 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
IAQ, None
|
61 Participants
|
38 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
DAQ, None
|
63 Participants
|
46 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
IAQ, Very slightly
|
42 Participants
|
38 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
DAQ, Very slightly
|
40 Participants
|
39 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
IAQ, Slightly
|
11 Participants
|
28 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
DAQ, Slightly
|
10 Participants
|
24 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
IAQ, Neither slightly nor moderately
|
2 Participants
|
1 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
DAQ, Neither slightly nor moderately
|
1 Participants
|
1 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
IAQ, Moderately
|
5 Participants
|
11 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
DAQ, Moderately
|
7 Participants
|
4 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
IAQ, Markedly
|
0 Participants
|
4 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
DAQ, Markedly
|
0 Participants
|
4 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
IAQ, Very markedly
|
0 Participants
|
1 Participants
|
|
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
DAQ, Very markedly
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per Protocol population comprised of all participants who complete both treatment periods. Only those participants available at the specified time points were analyzed.
Participant response for soothing feel at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ and DAQ having question: Did product feel soothing?. 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.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=121 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
IAQ, None
|
28 Participants
|
24 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
DAQ, None
|
26 Participants
|
25 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
IAQ, Very slight
|
28 Participants
|
31 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
DAQ, Very slight
|
34 Participants
|
31 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
IAQ, Slight
|
25 Participants
|
27 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
DAQ, Slight
|
25 Participants
|
29 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
IAQ, Neither slight nor moderate
|
17 Participants
|
16 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
DAQ, Neither slight nor moderate
|
15 Participants
|
11 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
IAQ, Moderate
|
15 Participants
|
16 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
DAQ, Moderate
|
11 Participants
|
19 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
IAQ, Marked
|
4 Participants
|
5 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
DAQ, Marked
|
5 Participants
|
6 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
IAQ, Very marked
|
4 Participants
|
2 Participants
|
|
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
DAQ, Very marked
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
Participant response regarding sneezing effect at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using IAQ having question: Did product make want to sneeze?. Participants specified their responses on a 6-point scale: 0: No urgency; 1: Very slight urgency; 2: slight urgency; 3: Neither slight nor moderate urgency; 4: Moderate urgency; 5; Marked urgency; 6: Very marked urgency.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=121 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Reported Product Make Want to Sneeze in IAQ
No urgency
|
87 Participants
|
93 Participants
|
|
Number of Participants Reported Product Make Want to Sneeze in IAQ
Very slight urgency
|
17 Participants
|
12 Participants
|
|
Number of Participants Reported Product Make Want to Sneeze in IAQ
Slight urgency
|
8 Participants
|
10 Participants
|
|
Number of Participants Reported Product Make Want to Sneeze in IAQ
Neither slight nor moderate urgency
|
2 Participants
|
2 Participants
|
|
Number of Participants Reported Product Make Want to Sneeze in IAQ
Moderate urgency
|
2 Participants
|
2 Participants
|
|
Number of Participants Reported Product Make Want to Sneeze in IAQ
Marked urgency
|
3 Participants
|
2 Participants
|
|
Number of Participants Reported Product Make Want to Sneeze in IAQ
Very marked urgency
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
Number of participants responding to product satisfaction with delayed attributes questionnaire, Question: How satisfied with product?. 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.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=120 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Satisfied With Product in DAQ
Very satisfied
|
44 Participants
|
34 Participants
|
|
Number of Participants Satisfied With Product in DAQ
Moderately satisfied
|
27 Participants
|
23 Participants
|
|
Number of Participants Satisfied With Product in DAQ
Somewhat satisfied
|
17 Participants
|
27 Participants
|
|
Number of Participants Satisfied With Product in DAQ
Neither satisfied nor dissatisfied
|
19 Participants
|
21 Participants
|
|
Number of Participants Satisfied With Product in DAQ
Somewhat dissatisfied
|
7 Participants
|
8 Participants
|
|
Number of Participants Satisfied With Product in DAQ
Moderately dissatisfied
|
5 Participants
|
7 Participants
|
|
Number of Participants Satisfied With Product in DAQ
Very dissatisfied
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
Participant response regarding nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: Did product cause nasal irritation?. Participants specified their responses on a 6-point scale: 0: none; 1: very slight; 2: slight; 3: neither slight nor moderate; 4: moderate; 5; marked; 6: very marked.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=121 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Reported Nasal Irritation in DAQ
None
|
89 Participants
|
78 Participants
|
|
Number of Participants Reported Nasal Irritation in DAQ
Very slight
|
18 Participants
|
21 Participants
|
|
Number of Participants Reported Nasal Irritation in DAQ
Slight
|
6 Participants
|
10 Participants
|
|
Number of Participants Reported Nasal Irritation in DAQ
Neither slight nor moderate
|
2 Participants
|
3 Participants
|
|
Number of Participants Reported Nasal Irritation in DAQ
Moderate
|
3 Participants
|
7 Participants
|
|
Number of Participants Reported Nasal Irritation in DAQ
Marked
|
2 Participants
|
1 Participants
|
|
Number of Participants Reported Nasal Irritation in DAQ
Very marked
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
Participant response regarding bothersome of nasal irritation at the end of crossover dosing with FF 110 µg and FP 200 µg was evaluated using DAQ having question: How bothersome was nasal irritation?. 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.
Outcome measures
| Measure |
Overall Study Arm
n=38 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=48 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Reported Nasal Irritation Bothersome in DAQ
None
|
7 Participants
|
7 Participants
|
|
Number of Participants Reported Nasal Irritation Bothersome in DAQ
Very slightly
|
15 Participants
|
22 Participants
|
|
Number of Participants Reported Nasal Irritation Bothersome in DAQ
Slightly
|
9 Participants
|
8 Participants
|
|
Number of Participants Reported Nasal Irritation Bothersome in DAQ
Neither slightly nor moderately
|
2 Participants
|
2 Participants
|
|
Number of Participants Reported Nasal Irritation Bothersome in DAQ
Moderately
|
4 Participants
|
6 Participants
|
|
Number of Participants Reported Nasal Irritation Bothersome in DAQ
Markedly
|
0 Participants
|
1 Participants
|
|
Number of Participants Reported Nasal Irritation Bothersome in DAQ
Very markedly
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
Number of participants responding to product attributes using delayed attributes questionnaire, Question: How likely to comply if prescribed?. Participants 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.
Outcome measures
| Measure |
Overall Study Arm
n=121 Participants
Eligible participants were randomized (1:1) to receive a single-dose treatment (2 sprays per nostril - 4 sprays in total). Sequence of either FP 200 µg /FF 110 µg or FF 110 µg /FP 200 µg in a crossover manner. Prior to receiving the first treatment sequence, participants underwent a washout procedure, which consisted of cleaning the mouth by eating one unsalted followed by several swallows of room temperature water and sniffing a swatch of wool. Participants then received the first treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Thirty minutes after the first treatment and prior to initialization of second washout period, Participants received the second treatment in their randomization sequence (FF or FP, 2 sprays per nostril). Participants completed two questionnaires, an immediate attributes questionnaire (administered immediately after dosing) followed by a delayed attributes questionnaire (administered 2 minutes after dosing).
|
FP 200 µg
n=120 Participants
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Number of Participants Comply With Product if Prescribed in DAQ
Very likely
|
63 Participants
|
45 Participants
|
|
Number of Participants Comply With Product if Prescribed in DAQ
Moderately likely
|
19 Participants
|
26 Participants
|
|
Number of Participants Comply With Product if Prescribed in DAQ
Somewhat likely
|
18 Participants
|
16 Participants
|
|
Number of Participants Comply With Product if Prescribed in DAQ
Neither likely nor unlikely
|
7 Participants
|
10 Participants
|
|
Number of Participants Comply With Product if Prescribed in DAQ
Slightly unlikely
|
4 Participants
|
12 Participants
|
|
Number of Participants Comply With Product if Prescribed in DAQ
Moderately unlikely
|
4 Participants
|
7 Participants
|
|
Number of Participants Comply With Product if Prescribed in DAQ
Very unlikely
|
6 Participants
|
4 Participants
|
Adverse Events
FF 110 µg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
FP 200 µg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FF 110 µg
n=127 participants at risk
Participants were randomized to receive a single dose of FF 110 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each spray of the suspension was containing approximately 27.5 µg of FF. 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
FP 200 µg
n=127 participants at risk
Participants were randomized to receive a single dose of FP 200 µg nasal spray (2 sprays per nostril - 4 sprays in total) for 30 minutes in treatment period 1 and 2. Each actuation delivered 50 µg of FP in 100 mg of formulation through the nasal adapter 2 attributes questionnaires (immediate and delayed) and an overall preference questionnaire were completed by participants during the course of the study.
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
0.79%
1/127 • Adverse events were reported throughout the treatment period (Day 1), as this is single day study which included pre treatment, washout, treatment periods 1 and 2
Intent-to-treat population was used which comprised of all participants who were randomized to study drug, formed the basis for all summaries of safety, background, and demographic data.
|
0.00%
0/127 • Adverse events were reported throughout the treatment period (Day 1), as this is single day study which included pre treatment, washout, treatment periods 1 and 2
Intent-to-treat population was used which comprised of all participants who were randomized to study drug, formed the basis for all summaries of safety, background, and demographic data.
|
|
Nervous system disorders
Headache
|
0.79%
1/127 • Adverse events were reported throughout the treatment period (Day 1), as this is single day study which included pre treatment, washout, treatment periods 1 and 2
Intent-to-treat population was used which comprised of all participants who were randomized to study drug, formed the basis for all summaries of safety, background, and demographic data.
|
0.00%
0/127 • Adverse events were reported throughout the treatment period (Day 1), as this is single day study which included pre treatment, washout, treatment periods 1 and 2
Intent-to-treat population was used which comprised of all participants who were randomized to study drug, formed the basis for all summaries of safety, background, and demographic data.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.79%
1/127 • Adverse events were reported throughout the treatment period (Day 1), as this is single day study which included pre treatment, washout, treatment periods 1 and 2
Intent-to-treat population was used which comprised of all participants who were randomized to study drug, formed the basis for all summaries of safety, background, and demographic data.
|
0.00%
0/127 • Adverse events were reported throughout the treatment period (Day 1), as this is single day study which included pre treatment, washout, treatment periods 1 and 2
Intent-to-treat population was used which comprised of all participants who were randomized to study drug, formed the basis for all summaries of safety, background, and demographic data.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
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