Rhinitis, Allergic, Perennial
Conditions
Keywords
taste, questionnaire, preference, attributes, odor, after taste, scent
Brief summary
The objectives of this study are to evaluate and compare patient preference for FF (Fluticasone Furoate) and FP (Fluticasone Propionate Aqueous)nasal sprays in the treatment of allergic rhinitis following single-dose administration.
Interventions
200 micrograms (mcg); an aqueous suspension of microfine FP
110 mcg; an aqueous suspension containing 0.05% w/w of micronized FF
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* allergic rhinitis * literate
Exclusion criteria
* clinical significant uncontrolled disease * Use of intranasal corticosteroids (\<4 weeks of FP \[branded or generic\],\<4 week exposure to FF, \<4 weeks use of other INS) * Use of intranasal medications \<1 week * Use of meds that significantly inhibit CYP4503A4 * Use of perfume or oral rinse on study day * Allergy/intolerance to INS, antihistamines, or excipients * Positive pregnancy test or female who is breastfeeding * Affiliation with investigational site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing | Day 1 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | Day 1 | 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. |
| Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | Day 1 | 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. |
| Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | Day 1 | 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. |
| Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | Day 1 | 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. |
| Number of Participants Reported Product Have an Immediate Taste in IAQ | Day 1 | 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. |
| Number of Participants Satisfied With an Immediate Taste in IAQ | Day 1 | 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. |
| Number of Participants Reported Product Have an After Taste in DAQ | Day 1 | 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. |
| Number of Participants Satisfied With an After Taste in DAQ | Day 1 | 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. |
| Number of Participants With Preference for Scent/Odor in IAQ and DAQ | Day 1 | 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. |
| Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | Day 1 | 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. |
| Number of Participants Reported Product Feel Soothing in IAQ and DAQ | Day 1 | 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. |
| Number of Participants Reported Product Make Want to Sneeze in IAQ | Day 1 | 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. |
| Number of Participants Satisfied With Product in DAQ | Day 1 | 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. |
| Number of Participants Reported Nasal Irritation in DAQ | Day 1 | 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. |
| Number of Participants Reported Nasal Irritation Bothersome in DAQ | Day 1 | 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. |
| Number of Participants Comply With Product if Prescribed in DAQ | Day 1 | 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. |
| Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | Day 1 | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Arm 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). | 127 |
| Total | 127 |
Baseline characteristics
| Characteristic | Overall Study Arm |
|---|---|
| Age, Continuous | 39.7 Years STANDARD_DEVIATION 14.05 |
| Race/Ethnicity, Customized Race African American/African Heritage | 20 Participants |
| Race/Ethnicity, Customized Race Asian - East Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized Race Asian - South East Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized Race Mixed Race | 2 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race White - Arabic/North African Heritage | 1 Participants |
| Race/Ethnicity, Customized Race White - White/Caucasian/European Heritage | 100 Participants |
| Sex: Female, Male Female | 82 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 127 | 0 / 127 |
| other Total, other adverse events | 3 / 127 | 0 / 127 |
| serious Total, serious adverse events | 0 / 127 | 0 / 127 |
Outcome results
Primary
Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing
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.
Time frame: Day 1
Population: Per Protocol population comprised of all participants who completed both treatment periods. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing | Overall, FF 110 µg | 72 Participants |
| Overall Study Arm | Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing | Overall, FP 200 µg | 39 Participants |
| Overall Study Arm | Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing | Overall, No preference | 9 Participants |
| Overall Study Arm | 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 Study Arm | 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 Study Arm | Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing | Scent/odor, No preference | 8 Participants |
| Overall Study Arm | 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 Study Arm | Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing | Immediate taste, FP 200 µg | 25 Participants |
| Overall Study Arm | Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing | Immediate taste, No preference | 39 Participants |
| Overall Study Arm | 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 Study Arm | 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 Study Arm | Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing | After-taste, No preference | 41 Participants |
| Overall Study Arm | 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 Study Arm | 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 Study Arm | 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 Study Arm | 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 Study Arm | 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 Study Arm | 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 Study Arm | 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 Study Arm | 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 Study Arm | Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing | More soothing, No preference | 37 Participants |
| Overall Study Arm | 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 Study Arm | 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 Study Arm | Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing | Less irritating, No preference | 53 Participants |
| Overall Study Arm | 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 Study Arm | 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 Study Arm | Overall Participants Preference for Nasal Spray Based on Selected Product Attributes at the End of Crossover Dosing | Urge to sneeze, No preference | 74 Participants |
Comparison: Analysis for overall product preferencep-value: 0.003Cochran-Mantel-Haenszel
Comparison: Analysis for Scent/odorp-value: <0.001Cochran-Mantel-Haenszel
Comparison: Analysis for Immediate tastep-value: <0.001Cochran-Mantel-Haenszel
Comparison: Analysis for After-tastep-value: 0.002Cochran-Mantel-Haenszel
Comparison: Analysis for Less drip down throatp-value: 0.037Cochran-Mantel-Haenszel
Comparison: Analysis for Less run out nosep-value: <0.001Cochran-Mantel-Haenszel
Comparison: Analysis for More soothingp-value: 0.408Cochran-Mantel-Haenszel
Comparison: Analysis for Less irritatingp-value: 0.07Cochran-Mantel-Haenszel
Comparison: Analysis for Urge to sneezep-value: 0.587Cochran-Mantel-Haenszel
Secondary
Number of Participants Comply With Product if Prescribed in DAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Comply With Product if Prescribed in DAQ | Somewhat likely | 18 Participants |
| Overall Study Arm | Number of Participants Comply With Product if Prescribed in DAQ | Slightly unlikely | 4 Participants |
| Overall Study Arm | Number of Participants Comply With Product if Prescribed in DAQ | Moderately likely | 19 Participants |
| Overall Study Arm | Number of Participants Comply With Product if Prescribed in DAQ | Moderately unlikely | 4 Participants |
| Overall Study Arm | Number of Participants Comply With Product if Prescribed in DAQ | Neither likely nor unlikely | 7 Participants |
| Overall Study Arm | Number of Participants Comply With Product if Prescribed in DAQ | Very unlikely | 6 Participants |
| Overall Study Arm | Number of Participants Comply With Product if Prescribed in DAQ | Very likely | 63 Participants |
| FP 200 µg | Number of Participants Comply With Product if Prescribed in DAQ | Very unlikely | 4 Participants |
| FP 200 µg | Number of Participants Comply With Product if Prescribed in DAQ | Very likely | 45 Participants |
| FP 200 µg | Number of Participants Comply With Product if Prescribed in DAQ | Moderately likely | 26 Participants |
| FP 200 µg | Number of Participants Comply With Product if Prescribed in DAQ | Somewhat likely | 16 Participants |
| FP 200 µg | Number of Participants Comply With Product if Prescribed in DAQ | Neither likely nor unlikely | 10 Participants |
| FP 200 µg | Number of Participants Comply With Product if Prescribed in DAQ | Slightly unlikely | 12 Participants |
| FP 200 µg | Number of Participants Comply With Product if Prescribed in DAQ | Moderately unlikely | 7 Participants |
p-value: 0.02Cochran-Mantel-Haenszel
Secondary
Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, None | 74 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, None | 64 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Very slightly | 28 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Very slightly | 36 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Slightly | 11 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Slightly | 12 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Neither slightly nor moderately | 3 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Neither slightly nor moderately | 1 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Moderately | 3 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Moderately | 5 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Markedly | 1 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Markedly | 3 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Very markedly | 1 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Very markedly | 0 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Markedly | 0 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, None | 69 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Neither slightly nor moderately | 3 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, None | 55 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Very markedly | 0 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Very slightly | 29 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Moderately | 3 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Very slightly | 37 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Markedly | 1 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Slightly | 15 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Moderately | 6 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Slightly | 17 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | DAQ, Very markedly | 1 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Down Throat in IAQ and DAQ | IAQ, Neither slightly nor moderately | 5 Participants |
Comparison: This analysis is for IAQp-value: 0.797Cochran-Mantel-Haenszel
Comparison: This analysis is for DAQp-value: 0.296Cochran-Mantel-Haenszel
Secondary
Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, None | 61 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, None | 63 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Very slightly | 42 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Very slightly | 40 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Slightly | 11 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Slightly | 10 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Neither slightly nor moderately | 2 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Neither slightly nor moderately | 1 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Moderately | 5 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Moderately | 7 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Markedly | 0 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Markedly | 0 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Very markedly | 0 Participants |
| Overall Study Arm | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Very markedly | 0 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Markedly | 4 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, None | 38 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Neither slightly nor moderately | 1 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, None | 46 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Very markedly | 1 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Very slightly | 38 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Moderately | 11 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Very slightly | 39 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Markedly | 4 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Slightly | 28 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Moderately | 4 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Slightly | 24 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | DAQ, Very markedly | 3 Participants |
| FP 200 µg | Number of Participants Reported Medicine Run Out of Nose in IAQ and DAQ | IAQ, Neither slightly nor moderately | 1 Participants |
Comparison: Comparison of FF 110 µg and FP 200 µg in IAQp-value: <0.001Cochran-Mantel-Haenszel
Comparison: Comparison of FF 110 µg and FP 200 µg in DAQp-value: <0.001Cochran-Mantel-Haenszel
Secondary
Number of Participants Reported Nasal Irritation Bothersome in DAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Slightly | 9 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Moderately | 4 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Very slightly | 15 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Markedly | 0 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Neither slightly nor moderately | 2 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Very markedly | 1 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation Bothersome in DAQ | None | 7 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Very markedly | 2 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation Bothersome in DAQ | None | 7 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Very slightly | 22 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Slightly | 8 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Neither slightly nor moderately | 2 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Moderately | 6 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation Bothersome in DAQ | Markedly | 1 Participants |
p-value: 0.694Cochran-Mantel-Haenszel
Secondary
Number of Participants Reported Nasal Irritation in DAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Reported Nasal Irritation in DAQ | Slight | 6 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation in DAQ | Moderate | 3 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation in DAQ | Very slight | 18 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation in DAQ | Marked | 2 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation in DAQ | Neither slight nor moderate | 2 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation in DAQ | Very marked | 1 Participants |
| Overall Study Arm | Number of Participants Reported Nasal Irritation in DAQ | None | 89 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation in DAQ | Very marked | 1 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation in DAQ | None | 78 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation in DAQ | Very slight | 21 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation in DAQ | Slight | 10 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation in DAQ | Neither slight nor moderate | 3 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation in DAQ | Moderate | 7 Participants |
| FP 200 µg | Number of Participants Reported Nasal Irritation in DAQ | Marked | 1 Participants |
p-value: 0.108Cochran-Mantel-Haenszel
Secondary
Number of Participants Reported Product Feel Soothing in IAQ and DAQ
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.
Time frame: Day 1
Population: Per Protocol population comprised of all participants who complete both treatment periods. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, None | 28 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, None | 26 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Very slight | 28 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Very slight | 34 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Slight | 25 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Slight | 25 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Neither slight nor moderate | 17 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Neither slight nor moderate | 15 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Moderate | 15 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Moderate | 11 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Marked | 4 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Marked | 5 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Very marked | 4 Participants |
| Overall Study Arm | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Very marked | 4 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Marked | 5 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, None | 24 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Neither slight nor moderate | 11 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, None | 25 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Very marked | 2 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Very slight | 31 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Moderate | 16 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Very slight | 31 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Marked | 6 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Slight | 27 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Moderate | 19 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Slight | 29 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | DAQ, Very marked | 0 Participants |
| FP 200 µg | Number of Participants Reported Product Feel Soothing in IAQ and DAQ | IAQ, Neither slight nor moderate | 16 Participants |
Comparison: This analysis is for DAQp-value: 0.797Cochran-Mantel-Haenszel
Comparison: This analysis is for IAQp-value: 0.968Cochran-Mantel-Haenszel
Secondary
Number of Participants Reported Product Have an After Taste in DAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Reported Product Have an After Taste in DAQ | Very mild aftertaste | 22 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an After Taste in DAQ | Slightly strong aftertaste | 2 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an After Taste in DAQ | No aftertaste | 90 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an After Taste in DAQ | Moderately strong aftertaste | 0 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an After Taste in DAQ | Mild aftertaste | 7 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an After Taste in DAQ | Very strong aftertaste | 0 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an After Taste in DAQ | Neither mild nor strong aftertaste | 0 Participants |
| FP 200 µg | Number of Participants Reported Product Have an After Taste in DAQ | Very strong aftertaste | 0 Participants |
| FP 200 µg | Number of Participants Reported Product Have an After Taste in DAQ | No aftertaste | 66 Participants |
| FP 200 µg | Number of Participants Reported Product Have an After Taste in DAQ | Very mild aftertaste | 33 Participants |
| FP 200 µg | Number of Participants Reported Product Have an After Taste in DAQ | Neither mild nor strong aftertaste | 3 Participants |
| FP 200 µg | Number of Participants Reported Product Have an After Taste in DAQ | Slightly strong aftertaste | 6 Participants |
| FP 200 µg | Number of Participants Reported Product Have an After Taste in DAQ | Moderately strong aftertaste | 3 Participants |
| FP 200 µg | Number of Participants Reported Product Have an After Taste in DAQ | Mild aftertaste | 10 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Number of Participants Reported Product Have an Immediate Taste in IAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Reported Product Have an Immediate Taste in IAQ | No taste | 98 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an Immediate Taste in IAQ | Slightly strong taste | 3 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an Immediate Taste in IAQ | Mild taste | 7 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an Immediate Taste in IAQ | Moderately strong taste | 1 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an Immediate Taste in IAQ | Very mild taste | 10 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an Immediate Taste in IAQ | Very strong taste | 0 Participants |
| Overall Study Arm | Number of Participants Reported Product Have an Immediate Taste in IAQ | Neither mild nor strong taste | 2 Participants |
| FP 200 µg | Number of Participants Reported Product Have an Immediate Taste in IAQ | Very strong taste | 0 Participants |
| FP 200 µg | Number of Participants Reported Product Have an Immediate Taste in IAQ | No taste | 69 Participants |
| FP 200 µg | Number of Participants Reported Product Have an Immediate Taste in IAQ | Very mild taste | 25 Participants |
| FP 200 µg | Number of Participants Reported Product Have an Immediate Taste in IAQ | Mild taste | 13 Participants |
| FP 200 µg | Number of Participants Reported Product Have an Immediate Taste in IAQ | Neither mild nor strong taste | 6 Participants |
| FP 200 µg | Number of Participants Reported Product Have an Immediate Taste in IAQ | Slightly strong taste | 6 Participants |
| FP 200 µg | Number of Participants Reported Product Have an Immediate Taste in IAQ | Moderately strong taste | 2 Participants |
p-value: <0.001Cochran-Mantel-Haenszel
Secondary
Number of Participants Reported Product Make Want to Sneeze in IAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Reported Product Make Want to Sneeze in IAQ | Slight urgency | 8 Participants |
| Overall Study Arm | Number of Participants Reported Product Make Want to Sneeze in IAQ | Moderate urgency | 2 Participants |
| Overall Study Arm | Number of Participants Reported Product Make Want to Sneeze in IAQ | Very slight urgency | 17 Participants |
| Overall Study Arm | Number of Participants Reported Product Make Want to Sneeze in IAQ | Marked urgency | 3 Participants |
| Overall Study Arm | Number of Participants Reported Product Make Want to Sneeze in IAQ | Neither slight nor moderate urgency | 2 Participants |
| Overall Study Arm | Number of Participants Reported Product Make Want to Sneeze in IAQ | Very marked urgency | 2 Participants |
| Overall Study Arm | Number of Participants Reported Product Make Want to Sneeze in IAQ | No urgency | 87 Participants |
| FP 200 µg | Number of Participants Reported Product Make Want to Sneeze in IAQ | Very marked urgency | 0 Participants |
| FP 200 µg | Number of Participants Reported Product Make Want to Sneeze in IAQ | No urgency | 93 Participants |
| FP 200 µg | Number of Participants Reported Product Make Want to Sneeze in IAQ | Very slight urgency | 12 Participants |
| FP 200 µg | Number of Participants Reported Product Make Want to Sneeze in IAQ | Slight urgency | 10 Participants |
| FP 200 µg | Number of Participants Reported Product Make Want to Sneeze in IAQ | Neither slight nor moderate urgency | 2 Participants |
| FP 200 µg | Number of Participants Reported Product Make Want to Sneeze in IAQ | Moderate urgency | 2 Participants |
| FP 200 µg | Number of Participants Reported Product Make Want to Sneeze in IAQ | Marked urgency | 2 Participants |
p-value: 0.221Cochran-Mantel-Haenszel
Secondary
Number of Participants Satisfied With an After Taste in DAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Satisfied With an After Taste in DAQ | Somewhat satisfied | 3 Participants |
| Overall Study Arm | Number of Participants Satisfied With an After Taste in DAQ | Somewhat dissatisfied | 3 Participants |
| Overall Study Arm | Number of Participants Satisfied With an After Taste in DAQ | Moderately satisfied | 8 Participants |
| Overall Study Arm | Number of Participants Satisfied With an After Taste in DAQ | Moderately dissatisfied | 2 Participants |
| Overall Study Arm | Number of Participants Satisfied With an After Taste in DAQ | Neither satisfied nor dissatisfied | 11 Participants |
| Overall Study Arm | Number of Participants Satisfied With an After Taste in DAQ | Very dissatisfied | 0 Participants |
| Overall Study Arm | Number of Participants Satisfied With an After Taste in DAQ | Very satisfied | 7 Participants |
| FP 200 µg | Number of Participants Satisfied With an After Taste in DAQ | Very dissatisfied | 0 Participants |
| FP 200 µg | Number of Participants Satisfied With an After Taste in DAQ | Very satisfied | 12 Participants |
| FP 200 µg | Number of Participants Satisfied With an After Taste in DAQ | Moderately satisfied | 9 Participants |
| FP 200 µg | Number of Participants Satisfied With an After Taste in DAQ | Somewhat satisfied | 7 Participants |
| FP 200 µg | Number of Participants Satisfied With an After Taste in DAQ | Neither satisfied nor dissatisfied | 15 Participants |
| FP 200 µg | Number of Participants Satisfied With an After Taste in DAQ | Somewhat dissatisfied | 9 Participants |
| FP 200 µg | Number of Participants Satisfied With an After Taste in DAQ | Moderately dissatisfied | 2 Participants |
p-value: 0.434Cochran-Mantel-Haenszel
Secondary
Number of Participants Satisfied With an Immediate Taste in IAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Satisfied With an Immediate Taste in IAQ | Somewhat satisfied | 6 Participants |
| Overall Study Arm | Number of Participants Satisfied With an Immediate Taste in IAQ | Somewhat dissatisfied | 3 Participants |
| Overall Study Arm | Number of Participants Satisfied With an Immediate Taste in IAQ | Moderately satisfied | 7 Participants |
| Overall Study Arm | Number of Participants Satisfied With an Immediate Taste in IAQ | Moderately dissatisfied | 1 Participants |
| Overall Study Arm | Number of Participants Satisfied With an Immediate Taste in IAQ | Neither satisfied nor dissatisfied | 9 Participants |
| Overall Study Arm | Number of Participants Satisfied With an Immediate Taste in IAQ | Very dissatisfied | 1 Participants |
| Overall Study Arm | Number of Participants Satisfied With an Immediate Taste in IAQ | Very satisfied | 6 Participants |
| FP 200 µg | Number of Participants Satisfied With an Immediate Taste in IAQ | Very dissatisfied | 0 Participants |
| FP 200 µg | Number of Participants Satisfied With an Immediate Taste in IAQ | Very satisfied | 12 Participants |
| FP 200 µg | Number of Participants Satisfied With an Immediate Taste in IAQ | Moderately satisfied | 9 Participants |
| FP 200 µg | Number of Participants Satisfied With an Immediate Taste in IAQ | Somewhat satisfied | 9 Participants |
| FP 200 µg | Number of Participants Satisfied With an Immediate Taste in IAQ | Neither satisfied nor dissatisfied | 15 Participants |
| FP 200 µg | Number of Participants Satisfied With an Immediate Taste in IAQ | Somewhat dissatisfied | 6 Participants |
| FP 200 µg | Number of Participants Satisfied With an Immediate Taste in IAQ | Moderately dissatisfied | 3 Participants |
p-value: 0.592Cochran-Mantel-Haenszel
Secondary
Number of Participants Satisfied With Product in DAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the indicated time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Satisfied With Product in DAQ | Somewhat satisfied | 17 Participants |
| Overall Study Arm | Number of Participants Satisfied With Product in DAQ | Somewhat dissatisfied | 7 Participants |
| Overall Study Arm | Number of Participants Satisfied With Product in DAQ | Moderately satisfied | 27 Participants |
| Overall Study Arm | Number of Participants Satisfied With Product in DAQ | Moderately dissatisfied | 5 Participants |
| Overall Study Arm | Number of Participants Satisfied With Product in DAQ | Neither satisfied nor dissatisfied | 19 Participants |
| Overall Study Arm | Number of Participants Satisfied With Product in DAQ | Very dissatisfied | 2 Participants |
| Overall Study Arm | Number of Participants Satisfied With Product in DAQ | Very satisfied | 44 Participants |
| FP 200 µg | Number of Participants Satisfied With Product in DAQ | Very dissatisfied | 0 Participants |
| FP 200 µg | Number of Participants Satisfied With Product in DAQ | Very satisfied | 34 Participants |
| FP 200 µg | Number of Participants Satisfied With Product in DAQ | Moderately satisfied | 23 Participants |
| FP 200 µg | Number of Participants Satisfied With Product in DAQ | Somewhat satisfied | 27 Participants |
| FP 200 µg | Number of Participants Satisfied With Product in DAQ | Neither satisfied nor dissatisfied | 21 Participants |
| FP 200 µg | Number of Participants Satisfied With Product in DAQ | Somewhat dissatisfied | 8 Participants |
| FP 200 µg | Number of Participants Satisfied With Product in DAQ | Moderately dissatisfied | 7 Participants |
p-value: 0.205Cochran-Mantel-Haenszel
Secondary
Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Somewhat satisfied | 4 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Somewhat dissatisfied | 3 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Moderately satisfied | 2 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Moderately dissatisfied | 0 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Neither satisfied nor dissatisfied | 8 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Very dissatisfied | 1 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Very satisfied | 56 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Very dissatisfied | 0 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Very satisfied | 14 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Moderately satisfied | 1 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Somewhat satisfied | 0 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Neither satisfied nor dissatisfied | 1 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Somewhat dissatisfied | 0 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in DAQ | DAQ, Moderately dissatisfied | 0 Participants |
Comparison: Comparison of FF 110 µg and FP 200 µg for DAQ Itemsp-value: 0.871Cochran-Mantel-Haenszel
Secondary
Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Somewhat satisfied | 1 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Somewhat dissatisfied | 2 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Moderately satisfied | 7 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Moderately dissatisfied | 0 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Neither satisfied nor dissatisfied | 6 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Very dissatisfied | 1 Participants |
| Overall Study Arm | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Very satisfied | 46 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Very dissatisfied | 1 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Very satisfied | 10 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Moderately satisfied | 2 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Somewhat satisfied | 0 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Neither satisfied nor dissatisfied | 1 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Somewhat dissatisfied | 0 Participants |
| FP 200 µg | Number of Participants Who Satisfied Not to Have Scent/Odor in IAQ | IAQ, Moderately dissatisfied | 0 Participants |
Comparison: Comparison of FF 110 µg and FP 200 µg for IAQ Irtemsp-value: 0.845Cochran-Mantel-Haenszel
Secondary
Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Somewhat satisfied | 12 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Somewhat dissatisfied | 5 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Moderately satisfied | 11 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Moderately dissatisfied | 0 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Neither satisfied nor dissatisfied | 10 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Very dissatisfied | 1 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Very satisfied | 14 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Very dissatisfied | 2 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Very satisfied | 19 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Moderately satisfied | 21 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Somewhat satisfied | 20 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Neither satisfied nor dissatisfied | 22 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Somewhat dissatisfied | 16 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in DAQ | DAQ, Moderately dissatisfied | 6 Participants |
Comparison: Comparison of FF 110 µg and FP 200 µg for all DAQ itemsp-value: 0.056Cochran-Mantel-Haenszel
Secondary
Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ
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.
Time frame: Day 1
Population: Per protocol population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Somewhat satisfied | 13 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Somewhat dissatisfied | 6 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Moderately satisfied | 12 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Moderately dissatisfied | 1 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Neither satisfied nor dissatisfied | 16 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Very dissatisfied | 2 Participants |
| Overall Study Arm | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Very satisfied | 11 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Very dissatisfied | 3 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Very satisfied | 16 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Moderately satisfied | 20 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Somewhat satisfied | 25 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Neither satisfied nor dissatisfied | 17 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Somewhat dissatisfied | 23 Participants |
| FP 200 µg | Number of Participants With Preference for Satisfaction With Scent/Odor in IAQ | IAQ, Moderately dissatisfied | 5 Participants |
Comparison: Comparison of FF 110 µg and FP 200 µg in IAQp-value: 0.255Cochran-Mantel-Haenszel
Secondary
Number of Participants With Preference for Scent/Odor in IAQ and DAQ
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.
Time frame: Day 1
Population: Per Protocol population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Very mild | 21 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Neither mild nor strong | 4 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, None | 62 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Mild | 19 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Slightly strong | 6 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Very mild | 27 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Moderately strong | 4 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Mild | 16 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Moderately strong | 2 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, None | 71 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Very strong | 1 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Neither mild nor strong | 2 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Very strong | 1 Participants |
| Overall Study Arm | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Slightly strong | 6 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Very strong | 3 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, None | 12 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, None | 16 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Very mild | 22 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Very mild | 39 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Mild | 35 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Mild | 29 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Neither mild nor strong | 7 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Neither mild nor strong | 4 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Slightly strong | 20 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Slightly strong | 20 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Moderately strong | 19 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | DAQ, Moderately strong | 10 Participants |
| FP 200 µg | Number of Participants With Preference for Scent/Odor in IAQ and DAQ | IAQ, Very strong | 5 Participants |
Comparison: Comparison of FF 110 µg and FP 200 µg for IAQ itemsp-value: <0.001Cochran-Mantel-Haenszel
Comparison: Comparison of FF 110 µg and FP 200 µg for DAQ itemsp-value: <0.001Cochran-Mantel-Haenszel