| 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. | Per Protocol population comprised of all participants who completed both treatment periods. Only those participants available at the indicated time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | 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 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). |
| | | Title | Denominators | Categories |
|---|
| Overall, FF 110 µg | | | | Overall, FP 200 µg | | | | Overall, No preference | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Analysis for overall product preference | Cochran-Mantel-Haenszel | | 0.003 | | | | | | | | | | | | | | Other | | | | | Cochran-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. | Per Protocol population. Only those participants available at the specified time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the specified time points were analyzed. | Posted | | Count of Participants | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the indicated time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the indicated time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the indicated time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the indicated time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the specified time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the indicated time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per Protocol population comprised of all participants who complete both treatment periods. Only those participants available at the specified time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the indicated time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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 |
|
| 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. | Per protocol population. Only those participants available at the indicated time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the indicated time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the indicated time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|
| 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. | Per protocol population. Only those participants available at the indicated time points were analyzed. | Posted | | Number | | Participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | FF 110 µg | 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. | | OG001 | 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. |
|