Rhinitis, Allergic, Seasonal
Conditions
Brief summary
The purpose of this study was to identify the lowest dosage of mometasone furoate nasal spray (MFNS) that provided adequate efficacy with an acceptable safety profile for children (ages 6-11) with seasonal allergic rhinitis (SAR). The MFNS dose levels of 25, 100, and 200 mcg QD were compared with beclomethasone dipropionate (BDP), as an active control, and placebo.
Interventions
DRUGMometasone furoate nasal spray
intranasal administration
DRUGBeclomethasone dipropionate nasal spray
intranasal administration
DRUGPlacebo nasal spray
intranasal administration
DRUGChlorpheniramine maleate syrup
oral administration
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Have at least a one-year history of seasonal allergic rhinitis which previously required treatment for tree and/or grass pollen * Have a positive skin test response to an appropriate tree and/or grass seasonal allergen within the last year. * Must be free of any clinically significant disease other than seasonal allergic rhinitis. * Must be pre-menarcheal.
Exclusion criteria
* History of asthma which requires chronic use of inhaled or systemic corticosteroids. * Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip. * History of rhinitis medicamentosa. * History of clinically significant nasal candidiasis. * History of multiple drug allergies or allergy/intolerance to corticosteroids or antihistamines. * History of upper respiratory tract or sinus infection that required antibiotic therapy within the previous 2 weeks, or viral upper respiratory infection within 7 days prior to Screening. * History of nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow. * History of dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines. * History of investigational drug use in the last 30 days. * History of immunotherapy (desensitizing therapy), unless on a stable maintenance schedule for at least one month prior to Screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | Baseline (Day 1) and Day 8 | The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | Baseline (Day 1) and Day 4 | The mean change from baseline at study day 4 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. |
| Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | Baseline (Day 1) and Day 15 | The mean change from baseline at study day 15 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. |
| Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | Baseline (Day 1) and Day 29 | The mean change from baseline at study day 29 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity. |
| Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant | Baseline and Days 1 through 15 (average over 15 days) | Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity. |
| Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant | Baseline and Days 16 through 29 (average over 15 days) | Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MFNS 25 mcg QD Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. | 137 |
| MFNS 100 mcg QD Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. | 135 |
| MFNS 200 mcg QD Mometasone furoate nasal spray 100 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. | 133 |
| BDP 84 mcg BID Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. | 138 |
| Placebo Matching placebo nasal spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. | 136 |
| Total | 679 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 3 | 4 | 3 |
| Overall Study | Did Not Meet Entry Requirements | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 3 | 1 | 2 |
| Overall Study | Treatment Failure | 1 | 0 | 0 | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 3 | 1 | 1 |
Baseline characteristics
| Characteristic | MFNS 25 mcg QD | Total | Placebo | BDP 84 mcg BID | MFNS 200 mcg QD | MFNS 100 mcg QD |
|---|---|---|---|---|---|---|
| Age, Continuous | 8.8 Years STANDARD_DEVIATION 1.5 | 8.8 Years STANDARD_DEVIATION 1.6 | 8.8 Years STANDARD_DEVIATION 1.6 | 8.7 Years STANDARD_DEVIATION 1.6 | 8.8 Years STANDARD_DEVIATION 1.6 | 8.7 Years STANDARD_DEVIATION 1.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 49 Participants | 11 Participants | 8 Participants | 8 Participants | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 61 Participants | 12 Participants | 11 Participants | 13 Participants | 13 Participants |
| Race (NIH/OMB) White | 114 Participants | 569 Participants | 113 Participants | 119 Participants | 112 Participants | 111 Participants |
| Sex: Female, Male Female | 52 Participants | 260 Participants | 52 Participants | 51 Participants | 54 Participants | 51 Participants |
| Sex: Female, Male Male | 85 Participants | 419 Participants | 84 Participants | 87 Participants | 79 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 137 | 0 / 135 | 0 / 133 | 0 / 138 | 0 / 136 |
| other Total, other adverse events | 62 / 137 | 62 / 135 | 58 / 133 | 59 / 138 | 64 / 136 |
| serious Total, serious adverse events | 1 / 137 | 0 / 135 | 1 / 133 | 0 / 138 | 0 / 136 |
Outcome results
Primary
Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator
The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.
Time frame: Baseline (Day 1) and Day 8
Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 8 visit data for TNSS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | Baseline | 7.8 Scores on a scale | Standard Deviation 1.7 |
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | Change From Baseline Day 8 | -2.8 Scores on a scale | Standard Deviation 2.6 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | Change From Baseline Day 8 | -2.8 Scores on a scale | Standard Deviation 2.6 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | Baseline | 8.1 Scores on a scale | Standard Deviation 1.7 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | Baseline | 7.9 Scores on a scale | Standard Deviation 1.6 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | Change From Baseline Day 8 | -2.8 Scores on a scale | Standard Deviation 2.5 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | Baseline | 8.0 Scores on a scale | Standard Deviation 1.7 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | Change From Baseline Day 8 | -2.8 Scores on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | Change From Baseline Day 8 | -1.9 Scores on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator | Baseline | 8.0 Scores on a scale | Standard Deviation 1.5 |
Comparison: Pairwise comparisons were performed using least square means from two-way analysis of variance (ANOVA).p-value: 0.95ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.78ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.98ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.01ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.82ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.98ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.01ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.8ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.02ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.01ANOVA
Secondary
Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant
Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.
Time frame: Baseline and Days 16 through 29 (average over 15 days)
Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available diary data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant | Baseline | 6.3 Scores on a scale | Standard Deviation 2.3 |
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant | Change From Baseline Days 16 to 29 | -2.1 Scores on a scale | Standard Deviation 2.6 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant | Baseline | 6.9 Scores on a scale | Standard Deviation 2.4 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant | Change From Baseline Days 16 to 29 | -2.8 Scores on a scale | Standard Deviation 2.8 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant | Baseline | 6.9 Scores on a scale | Standard Deviation 2.4 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant | Change From Baseline Days 16 to 29 | -2.7 Scores on a scale | Standard Deviation 2.7 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant | Change From Baseline Days 16 to 29 | -2.6 Scores on a scale | Standard Deviation 2.8 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant | Baseline | 6.6 Scores on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant | Baseline | 6.8 Scores on a scale | Standard Deviation 2.5 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM)/Evening (PM) Score] Averaged Over Days 16 to 29 as Assessed by Participant | Change From Baseline Days 16 to 29 | -1.7 Scores on a scale | Standard Deviation 2.7 |
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.05ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.07ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.11ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.31ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.94ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.73ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: <0.01ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.79ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: <0.01ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: <0.01ANOVA
Secondary
Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant
Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.
Time frame: Baseline and Days 1 through 15 (average over 15 days)
Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available diary data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant | Baseline | 6.3 Scores on a scale | Standard Deviation 2.3 |
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant | Change From Baseline Days 1 to 15 | -1.5 Scores on a scale | Standard Deviation 2.1 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant | Baseline | 6.9 Scores on a scale | Standard Deviation 2.4 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant | Change From Baseline Days 1 to 15 | -1.9 Scores on a scale | Standard Deviation 2 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant | Baseline | 6.9 Scores on a scale | Standard Deviation 2.4 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant | Change From Baseline Days 1 to 15 | -1.8 Scores on a scale | Standard Deviation 2.1 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant | Change From Baseline Days 1 to 15 | -1.9 Scores on a scale | Standard Deviation 2.1 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant | Baseline | 6.6 Scores on a scale | Standard Deviation 2.4 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant | Baseline | 6.8 Scores on a scale | Standard Deviation 2.5 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) [Average of Morning (AM), Evening (PM) Score] Averaged Over Days 1 to 15 as Assessed by Participant | Change From Baseline Days 1 to 15 | -1.2 Scores on a scale | Standard Deviation 2 |
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.16ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.22ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.14ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.14ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.85ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.96ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: <0.01ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.81ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: <0.01ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: <0.01ANOVA
Secondary
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator
The mean change from baseline at study day 15 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.
Time frame: Baseline (Day 1) and Day 15
Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 15 visit data for TNSS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | Change From Baseline Day 15 | -2.9 Scores on a scale | Standard Deviation 2.7 |
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | Baseline | 7.8 Scores on a scale | Standard Deviation 1.7 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | Change From Baseline Day 15 | -3.0 Scores on a scale | Standard Deviation 2.8 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | Baseline | 8.1 Scores on a scale | Standard Deviation 1.7 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | Baseline | 7.9 Scores on a scale | Standard Deviation 1.6 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | Change From Baseline Day 15 | -3.1 Scores on a scale | Standard Deviation 2.7 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | Baseline | 8.0 Scores on a scale | Standard Deviation 1.7 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | Change From Baseline Day 15 | -3.5 Scores on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | Change From Baseline Day 15 | -2.4 Scores on a scale | Standard Deviation 2.8 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 15 as Assessed by Investigator | Baseline | 8.0 Scores on a scale | Standard Deviation 1.5 |
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.8ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.45ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.12ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.36ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.6ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.17ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.23ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.42ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.09ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.01ANOVA
Secondary
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator
The mean change from baseline at study day 29 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.
Time frame: Baseline (Day 1) and Day 29
Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 29 visit data for TNSS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | Baseline | 7.8 Scores on a scale | Standard Deviation 1.7 |
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | Change From Baseline Day 29 | -3.1 Scores on a scale | Standard Deviation 2.9 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | Baseline | 8.1 Scores on a scale | Standard Deviation 1.7 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | Change From Baseline Day 29 | -3.7 Scores on a scale | Standard Deviation 2.8 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | Baseline | 7.9 Scores on a scale | Standard Deviation 1.6 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | Change From Baseline Day 29 | -3.8 Scores on a scale | Standard Deviation 2.6 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | Change From Baseline Day 29 | -3.7 Scores on a scale | Standard Deviation 3 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | Baseline | 8.0 Scores on a scale | Standard Deviation 1.7 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | Baseline | 8.0 Scores on a scale | Standard Deviation 1.5 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 29 as Assessed by Investigator | Change From Baseline Day 29 | -2.5 Scores on a scale | Standard Deviation 2.8 |
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: <0.01ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.03ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.04ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.08ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.49ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.93ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.75ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.71ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: <0.01ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.01ANOVA
Secondary
Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator
The mean change from baseline at study day 4 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.
Time frame: Baseline (Day 1) and Day 4
Population: All randomized participants with a baseline score who completed at least one valid post-baseline visit and had available Day 4 visit data for TNSS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | Change From Baseline Day 4 | -2.2 Scores on a scale | Standard Deviation 2.4 |
| MFNS 25 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | Baseline | 7.8 Scores on a scale | Standard Deviation 1.7 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | Baseline | 8.1 Scores on a scale | Standard Deviation 1.7 |
| MFNS 100 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | Change From Baseline Day 4 | -2.0 Scores on a scale | Standard Deviation 2.1 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | Change From Baseline Day 4 | -2.0 Scores on a scale | Standard Deviation 2.5 |
| MFNS 200 mcg QD | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | Baseline | 7.9 Scores on a scale | Standard Deviation 1.6 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | Baseline | 8.0 Scores on a scale | Standard Deviation 1.7 |
| BDP 84 mcg BID | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | Change From Baseline Day 4 | -2.4 Scores on a scale | Standard Deviation 2.3 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | Change From Baseline Day 4 | -1.3 Scores on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) on Day 4 as Assessed by Investigator | Baseline | 8.0 Scores on a scale | Standard Deviation 1.5 |
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.56ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.74ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.68ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: <0.01ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.81ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.33ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.01ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: 0.46ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: <0.01ANOVA
Comparison: Pairwise comparisons were performed using least square means from two-way ANOVA.p-value: <0.01ANOVA