Seasonal Allergic Rhinitis
Conditions
Brief summary
The objectives of this study are to determine the safety and efficacy in seasonal allergic rhinitis of a four-week course of mometasone furoate compared to beclomethasone dipropionate or placebo.
Interventions
DRUGMometasone Furoate (MF)
Mometasone furoate nasal spray administered as 200 mcg total dose per day for 4 weeks.
Beclomethasone dipropionate nasal spray administered as 168 mcg twice daily (BID) \[336 mcg total dose per day\] for 4 weeks.
DRUGPlacebo
Placebo nasal spray administered for 4 weeks.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Nonpregnant women of childbearing potential must be using a medically acceptable form of birth control for at least 3 months prior to Screening, and must continue its use for the duration of the study. Women not of childbearing potential must be surgically sterilized or at least one year post menopausal, or be otherwise incapable of bearing children * 2-year history of seasonal allergic rhinitis * Positive skin test response to a local seasonal allergen within last 2 years * Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis
Exclusion criteria
* Women who are pregnant or breastfeeding * Women of childbearing potential who are not using an acceptable form of birth control * Pre-menarchal females * Asthma requiring therapy with inhaled or systemic corticosteroids * Significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical illness or disorder which, in the judgment of the investigator, may interfere with the study, or require treatment which might interfere with the study * On immunotherapy (unless maintenance therapy) * Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks * Use of any investigational drug within the previous 90 days unless the investigational drug is a nasal corticosteroid or has a short (12 hours or less) duration of action, in which case the washout period will be 30 days * Large nasal polyps, marked septal deviations or any other nasal structural abnormality that significantly interferes with nasal air flow * Allergy to corticosteroids, or a history of multiple drug allergies * History of posterior subcapsular cataracts * Dependence upon nasal, oral or ocular decongestants or who are diagnosed with rhinitis medicamentosa * Chronic use of any medication which could affect the course of seasonal allergic rhinitis * Clinically significant abnormal electrocardiogram (ECG)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated) | Baseline, and Days 1 through 15 (average of 15 days of treatment) | TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching, as rated in their diary in the morning (AM) and evening (PM). The 4 individual symptom scores rated as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For the 15 day interval, participant individual daily scores were totaled and averaged over interval (AM and PM computed separately then averaged) and used to calculate the overall average change from Baseline. Participant average changes were then used to calculate the mean change for each arm for the interval. Average change from Baseline for Days 1-15 = average post-treatment score (Days 1-15) - Baseline average score (average of the Baseline AM/PM diary scores from 3 consecutive days prior to Baseline visit). Negative changes from baseline indicate a decrease in symptom severity. |
| Number of Participants Who Experienced ≥1 Adverse Event | Up to 31 Days | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants with at least one AE was reported for each treatment group. |
| Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE) | Up to 31 Days | An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who discontinued due to an AE was reported for each treatment group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the TNSS At Day 22 (Physician-Evaluated) | Baseline (Day 1), Day 22 | TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity. |
| Change From Baseline in the TNSS At Day 29 (Physician-Evaluated) | Baseline (Day 1), Day 29 | TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated) | Baseline (Day 1), Day 4 | Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated) | Baseline (Day 1), Day 8 | Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated) | Baseline (Day 1), Day 15 | Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated) | Baseline (Day 1), Day 22 | Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated) | Baseline (Day 1), Day 29 | Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated) | Baseline (Day 1), Day 4 | Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated) | Baseline (Day 1), Day 8 | Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated) | Baseline (Day 1), Day 15 | Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated) | Baseline (Day 1), Day 22 | Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. |
| Change From Baseline in the TNSS At Day 4 (Physician-Evaluated) | Baseline (Day 1), Day 4 | TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity. |
| Response To Therapy At Day 4 (Physician-Evaluated) | Day 4 | Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. |
| Response To Therapy At Day 8 (Physician-Evaluated) | Day 8 | Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. |
| Response To Therapy At Day 15 (Physician-Evaluated) | Day 15 | Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. |
| Response To Therapy At Day 22 (Physician-Evaluated) | Day 22 | Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. |
| Response To Therapy At Day 29 (Physician-Evaluated) | Day 29 | Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. |
| Response To Therapy At Day 4 (Participant-Evaluated) | Day 4 | Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. |
| Response To Therapy At Day 8 (Participant-Evaluated) | Day 8 | Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. |
| Response To Therapy At Day 15 (Participant-Evaluated) | Day 15 | Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. |
| Response To Therapy At Day 22 (Participant-Evaluated) | Day 22 | Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. |
| Response To Therapy At Day 29 (Participant-Evaluated) | Day 29 | Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated) | Baseline (Day 1), Day 29 | Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity. |
| Change From Baseline in the TNSS At Day 8 (Physician-Evaluated) | Baseline (Day 1), Day 8 | TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity. |
| Change From Baseline in the TNSS At Day 15 (Physician-Evaluated) | Baseline (Day 1), Day 15 | TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Furoate (MF) Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days. | 113 |
| Beclomethasone Dipropionate (BDP) Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days. | 116 |
| Placebo Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days. | 116 |
| Total | 345 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 5 | 2 | 4 |
| Overall Study | Did Not Return | 4 | 3 | 0 |
| Overall Study | Noncompliance with Protocol | 0 | 1 | 0 |
| Overall Study | Treatment Failure | 1 | 1 | 2 |
Baseline characteristics
| Characteristic | Mometasone Furoate (MF) | Beclomethasone Dipropionate (BDP) | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 34.8 Years STANDARD_DEVIATION 12.3 | 34.6 Years STANDARD_DEVIATION 12.1 | 35.5 Years STANDARD_DEVIATION 11.2 | 34.9 Years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 52 Participants | 52 Participants | 72 Participants | 176 Participants |
| Sex: Female, Male Male | 61 Participants | 64 Participants | 44 Participants | 169 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 112 | 0 / 116 | 0 / 116 |
| other Total, other adverse events | 47 / 112 | 38 / 116 | 53 / 116 |
| serious Total, serious adverse events | 0 / 112 | 0 / 116 | 0 / 116 |
Outcome results
Primary
Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching, as rated in their diary in the morning (AM) and evening (PM). The 4 individual symptom scores rated as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For the 15 day interval, participant individual daily scores were totaled and averaged over interval (AM and PM computed separately then averaged) and used to calculate the overall average change from Baseline. Participant average changes were then used to calculate the mean change for each arm for the interval. Average change from Baseline for Days 1-15 = average post-treatment score (Days 1-15) - Baseline average score (average of the Baseline AM/PM diary scores from 3 consecutive days prior to Baseline visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline, and Days 1 through 15 (average of 15 days of treatment)
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available diary data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated) | Baseline | 7.6 score on a scale | Standard Deviation 2.2 |
| Mometasone Furoate (MF) | Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated) | Change from Baseline Days 1-15 | -2.3 score on a scale | Standard Deviation 2.7 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated) | Baseline | 7.3 score on a scale | Standard Deviation 2.2 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated) | Change from Baseline Days 1-15 | -2.8 score on a scale | Standard Deviation 2.1 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated) | Baseline | 7.6 score on a scale | Standard Deviation 2 |
| Placebo | Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated) | Change from Baseline Days 1-15 | -1.5 score on a scale | Standard Deviation 2.1 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from ANOVA.p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from ANOVA.p-value: 0.06ANOVA
Primary
Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who discontinued due to an AE was reported for each treatment group.
Time frame: Up to 31 Days
Population: All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mometasone Furoate (MF) | Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE) | 5 Participants |
| Beclomethasone Dipropionate (BDP) | Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE) | 2 Participants |
| Placebo | Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE) | 4 Participants |
Primary
Number of Participants Who Experienced ≥1 Adverse Event
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants with at least one AE was reported for each treatment group.
Time frame: Up to 31 Days
Population: All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mometasone Furoate (MF) | Number of Participants Who Experienced ≥1 Adverse Event | 60 Participants |
| Beclomethasone Dipropionate (BDP) | Number of Participants Who Experienced ≥1 Adverse Event | 64 Participants |
| Placebo | Number of Participants Who Experienced ≥1 Adverse Event | 78 Participants |
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 15
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for SAR overall condition (participant-evaluated).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.5 |
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated) | Change From Baseline Day 15 | -0.7 scores on a scale | Standard Deviation 0.8 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.5 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated) | Change From Baseline Day 15 | -0.8 scores on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated) | Baseline | 2.3 scores on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated) | Change From Baseline Day 15 | -0.5 scores on a scale | Standard Deviation 0.8 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.07ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.43ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 15
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for SAR overall condition (physician-evaluated).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated) | Baseline | 2.3 scores on a scale | Standard Deviation 0.5 |
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated) | Change From Baseline Day 15 | -0.7 scores on a scale | Standard Deviation 0.8 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.4 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated) | Change From Baseline Day 15 | -0.8 scores on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.1 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated) | Change From Baseline Day 15 | -0.5 scores on a scale | Standard Deviation 0.7 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.03ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.54ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 22
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for SAR overall condition (participant-evaluated).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.5 |
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated) | Change From Baseline Day 22 | -0.9 scores on a scale | Standard Deviation 0.8 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.5 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated) | Change From Baseline Day 22 | -0.9 scores on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated) | Baseline | 2.3 scores on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated) | Change From Baseline Day 22 | -0.7 scores on a scale | Standard Deviation 0.8 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.09ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.08ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.96ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 22
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for SAR overall condition (physician-evaluated).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated) | Baseline | 2.3 scores on a scale | Standard Deviation 0.5 |
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated) | Change From Baseline Day 22 | -0.9 scores on a scale | Standard Deviation 0.8 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.4 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated) | Change From Baseline Day 22 | -0.8 scores on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.1 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated) | Change From Baseline Day 22 | -0.6 scores on a scale | Standard Deviation 0.7 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.71ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 29
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for SAR overall condition (participant-evaluated).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.5 |
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated) | Change From Baseline Day 29 | -0.9 scores on a scale | Standard Deviation 0.9 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.5 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated) | Change From Baseline Day 29 | -0.9 scores on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated) | Baseline | 2.3 scores on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated) | Change From Baseline Day 29 | -0.6 scores on a scale | Standard Deviation 0.8 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.64ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 29
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for SAR overall condition (physician-evaluated).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated) | Baseline | 2.3 scores on a scale | Standard Deviation 0.5 |
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated) | Change From Baseline Day 29 | -0.9 scores on a scale | Standard Deviation 0.9 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.4 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated) | Change From Baseline Day 29 | -0.9 scores on a scale | Standard Deviation 0.8 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.1 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated) | Change From Baseline Day 29 | -0.6 scores on a scale | Standard Deviation 0.8 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.77ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 4
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for SAR overall condition (participant-evaluated).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.5 |
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated) | Change From Baseline Day 4 | -0.6 scores on a scale | Standard Deviation 0.8 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.5 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated) | Change From Baseline Day 4 | -0.6 scores on a scale | Standard Deviation 0.6 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated) | Baseline | 2.3 scores on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated) | Change From Baseline Day 4 | -0.4 scores on a scale | Standard Deviation 0.7 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.11ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.03ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.6ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 4
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for SAR overall condition (physician-evaluated).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated) | Baseline | 2.3 scores on a scale | Standard Deviation 0.5 |
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated) | Change From Baseline Day 4 | -0.6 scores on a scale | Standard Deviation 0.7 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.4 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated) | Change From Baseline Day 4 | -0.5 scores on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.1 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated) | Change From Baseline Day 4 | -0.3 scores on a scale | Standard Deviation 0.7 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.02ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.39ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 8
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for SAR overall condition (participant-evaluated).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.5 |
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated) | Change From Baseline Day 8 | -0.7 scores on a scale | Standard Deviation 0.8 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.5 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated) | Change From Baseline Day 8 | -0.8 scores on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated) | Baseline | 2.3 scores on a scale | Standard Deviation 0.5 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated) | Change From Baseline Day 8 | -0.4 scores on a scale | Standard Deviation 0.8 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.59ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated)
Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 8
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for SAR overall condition (physician-evaluated).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated) | Baseline | 2.3 scores on a scale | Standard Deviation 0.5 |
| Mometasone Furoate (MF) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated) | Change From Baseline Day 8 | -0.7 scores on a scale | Standard Deviation 0.8 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.4 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated) | Change From Baseline Day 8 | -0.8 scores on a scale | Standard Deviation 0.7 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated) | Baseline | 2.2 scores on a scale | Standard Deviation 0.1 |
| Placebo | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated) | Change From Baseline Day 8 | -0.3 scores on a scale | Standard Deviation 0.8 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.6ANOVA
Secondary
Change From Baseline in the TNSS At Day 15 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 15
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for TNSS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in the TNSS At Day 15 (Physician-Evaluated) | Baseline | 8.3 scores on a scale | Standard Deviation 1.7 |
| Mometasone Furoate (MF) | Change From Baseline in the TNSS At Day 15 (Physician-Evaluated) | Change From Baseline Day 15 | -3.3 scores on a scale | Standard Deviation 2.9 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the TNSS At Day 15 (Physician-Evaluated) | Baseline | 7.9 scores on a scale | Standard Deviation 1.7 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the TNSS At Day 15 (Physician-Evaluated) | Change From Baseline Day 15 | -3.8 scores on a scale | Standard Deviation 2.7 |
| Placebo | Change From Baseline in the TNSS At Day 15 (Physician-Evaluated) | Baseline | 8.4 scores on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in the TNSS At Day 15 (Physician-Evaluated) | Change From Baseline Day 15 | -2.6 scores on a scale | Standard Deviation 2.5 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.05ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.13ANOVA
Secondary
Change From Baseline in the TNSS At Day 22 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 22
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for TNSS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in the TNSS At Day 22 (Physician-Evaluated) | Baseline | 8.3 scores on a scale | Standard Deviation 1.7 |
| Mometasone Furoate (MF) | Change From Baseline in the TNSS At Day 22 (Physician-Evaluated) | Change From Baseline Day 22 | -3.9 scores on a scale | Standard Deviation 2.9 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the TNSS At Day 22 (Physician-Evaluated) | Baseline | 7.9 scores on a scale | Standard Deviation 1.7 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the TNSS At Day 22 (Physician-Evaluated) | Change From Baseline Day 22 | -4.0 scores on a scale | Standard Deviation 2.7 |
| Placebo | Change From Baseline in the TNSS At Day 22 (Physician-Evaluated) | Baseline | 8.4 scores on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in the TNSS At Day 22 (Physician-Evaluated) | Change From Baseline Day 22 | -3.2 scores on a scale | Standard Deviation 2.8 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.06ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.03ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.81ANOVA
Secondary
Change From Baseline in the TNSS At Day 29 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 29
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for TNSS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in the TNSS At Day 29 (Physician-Evaluated) | Baseline | 8.3 scores on a scale | Standard Deviation 1.7 |
| Mometasone Furoate (MF) | Change From Baseline in the TNSS At Day 29 (Physician-Evaluated) | Change From Baseline Day 29 | -4.1 scores on a scale | Standard Deviation 2.9 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the TNSS At Day 29 (Physician-Evaluated) | Baseline | 7.9 scores on a scale | Standard Deviation 1.7 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the TNSS At Day 29 (Physician-Evaluated) | Change From Baseline Day 29 | -4.6 scores on a scale | Standard Deviation 2.6 |
| Placebo | Change From Baseline in the TNSS At Day 29 (Physician-Evaluated) | Baseline | 8.4 scores on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in the TNSS At Day 29 (Physician-Evaluated) | Change From Baseline Day 29 | -3.2 scores on a scale | Standard Deviation 2.7 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.02ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.17ANOVA
Secondary
Change From Baseline in the TNSS At Day 4 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 4
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for TNSS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in the TNSS At Day 4 (Physician-Evaluated) | Baseline | 8.3 scores on a scale | Standard Deviation 1.7 |
| Mometasone Furoate (MF) | Change From Baseline in the TNSS At Day 4 (Physician-Evaluated) | Change From Baseline Day 4 | -2.4 scores on a scale | Standard Deviation 2.8 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the TNSS At Day 4 (Physician-Evaluated) | Baseline | 7.9 scores on a scale | Standard Deviation 1.7 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the TNSS At Day 4 (Physician-Evaluated) | Change From Baseline Day 4 | -2.7 scores on a scale | Standard Deviation 2.2 |
| Placebo | Change From Baseline in the TNSS At Day 4 (Physician-Evaluated) | Baseline | 8.4 scores on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in the TNSS At Day 4 (Physician-Evaluated) | Change From Baseline Day 4 | -1.8 scores on a scale | Standard Deviation 2.5 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.04ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.5ANOVA
Secondary
Change From Baseline in the TNSS At Day 8 (Physician-Evaluated)
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity.
Time frame: Baseline (Day 1), Day 8
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for TNSS.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate (MF) | Change From Baseline in the TNSS At Day 8 (Physician-Evaluated) | Baseline | 8.3 scores on a scale | Standard Deviation 1.7 |
| Mometasone Furoate (MF) | Change From Baseline in the TNSS At Day 8 (Physician-Evaluated) | Change From Baseline Day 8 | -3.3 scores on a scale | Standard Deviation 2.9 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the TNSS At Day 8 (Physician-Evaluated) | Baseline | 7.9 scores on a scale | Standard Deviation 1.7 |
| Beclomethasone Dipropionate (BDP) | Change From Baseline in the TNSS At Day 8 (Physician-Evaluated) | Change From Baseline Day 8 | -3.8 scores on a scale | Standard Deviation 2.3 |
| Placebo | Change From Baseline in the TNSS At Day 8 (Physician-Evaluated) | Baseline | 8.4 scores on a scale | Standard Deviation 1.6 |
| Placebo | Change From Baseline in the TNSS At Day 8 (Physician-Evaluated) | Change From Baseline Day 8 | -1.9 scores on a scale | Standard Deviation 2.7 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.11ANOVA
Secondary
Response To Therapy At Day 15 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 15
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for response (participant-evaluated).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate (MF) | Response To Therapy At Day 15 (Participant-Evaluated) | 3.0 scores on a scale | Standard Deviation 1.1 |
| Beclomethasone Dipropionate (BDP) | Response To Therapy At Day 15 (Participant-Evaluated) | 2.7 scores on a scale | Standard Deviation 0.9 |
| Placebo | Response To Therapy At Day 15 (Participant-Evaluated) | 3.3 scores on a scale | Standard Deviation 1 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.06ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.03ANOVA
Secondary
Response To Therapy At Day 15 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 15
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for response (physician-evaluated).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate (MF) | Response To Therapy At Day 15 (Physician-Evaluated) | 3.0 scores on a scale | Standard Deviation 1.1 |
| Beclomethasone Dipropionate (BDP) | Response To Therapy At Day 15 (Physician-Evaluated) | 2.8 scores on a scale | Standard Deviation 1 |
| Placebo | Response To Therapy At Day 15 (Physician-Evaluated) | 3.3 scores on a scale | Standard Deviation 1 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.05ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.07ANOVA
Secondary
Response To Therapy At Day 22 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 22
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for response (participant-evaluated).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate (MF) | Response To Therapy At Day 22 (Participant-Evaluated) | 2.9 scores on a scale | Standard Deviation 1.1 |
| Beclomethasone Dipropionate (BDP) | Response To Therapy At Day 22 (Participant-Evaluated) | 2.7 scores on a scale | Standard Deviation 1.1 |
| Placebo | Response To Therapy At Day 22 (Participant-Evaluated) | 3.1 scores on a scale | Standard Deviation 1.1 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.13ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.07ANOVA
Secondary
Response To Therapy At Day 22 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 22
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for response (physician-evaluated).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate (MF) | Response To Therapy At Day 22 (Physician-Evaluated) | 2.8 scores on a scale | Standard Deviation 1.1 |
| Beclomethasone Dipropionate (BDP) | Response To Therapy At Day 22 (Physician-Evaluated) | 2.7 scores on a scale | Standard Deviation 1.1 |
| Placebo | Response To Therapy At Day 22 (Physician-Evaluated) | 3.1 scores on a scale | Standard Deviation 1.2 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.04ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.53ANOVA
Secondary
Response To Therapy At Day 29 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 29
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for response (participant-evaluated).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate (MF) | Response To Therapy At Day 29 (Participant-Evaluated) | 2.9 scores on a scale | Standard Deviation 1.1 |
| Beclomethasone Dipropionate (BDP) | Response To Therapy At Day 29 (Participant-Evaluated) | 2.6 scores on a scale | Standard Deviation 1.1 |
| Placebo | Response To Therapy At Day 29 (Participant-Evaluated) | 3.3 scores on a scale | Standard Deviation 1.1 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.03ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.01ANOVA
Secondary
Response To Therapy At Day 29 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 29
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for response (physician-evaluated).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate (MF) | Response To Therapy At Day 29 (Physician-Evaluated) | 2.9 scores on a scale | Standard Deviation 1.2 |
| Beclomethasone Dipropionate (BDP) | Response To Therapy At Day 29 (Physician-Evaluated) | 2.5 scores on a scale | Standard Deviation 1.2 |
| Placebo | Response To Therapy At Day 29 (Physician-Evaluated) | 3.2 scores on a scale | Standard Deviation 1.2 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.02ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.02ANOVA
Secondary
Response To Therapy At Day 4 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 4
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for response (participant-evaluated).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate (MF) | Response To Therapy At Day 4 (Participant-Evaluated) | 3.3 scores on a scale | Standard Deviation 1 |
| Beclomethasone Dipropionate (BDP) | Response To Therapy At Day 4 (Participant-Evaluated) | 3.2 scores on a scale | Standard Deviation 0.9 |
| Placebo | Response To Therapy At Day 4 (Participant-Evaluated) | 3.6 scores on a scale | Standard Deviation 0.9 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.03ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.34ANOVA
Secondary
Response To Therapy At Day 4 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 4
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for response (physician-evaluated).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate (MF) | Response To Therapy At Day 4 (Physician-Evaluated) | 3.3 scores on a scale | Standard Deviation 1.2 |
| Beclomethasone Dipropionate (BDP) | Response To Therapy At Day 4 (Physician-Evaluated) | 3.2 scores on a scale | Standard Deviation 1.1 |
| Placebo | Response To Therapy At Day 4 (Physician-Evaluated) | 3.5 scores on a scale | Standard Deviation 1.1 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.25ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.02ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.26ANOVA
Secondary
Response To Therapy At Day 8 (Participant-Evaluated)
Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 8
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for response (participant-evaluated).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate (MF) | Response To Therapy At Day 8 (Participant-Evaluated) | 3.0 scores on a scale | Standard Deviation 1 |
| Beclomethasone Dipropionate (BDP) | Response To Therapy At Day 8 (Participant-Evaluated) | 2.7 scores on a scale | Standard Deviation 1 |
| Placebo | Response To Therapy At Day 8 (Participant-Evaluated) | 3.5 scores on a scale | Standard Deviation 1 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.04ANOVA
Secondary
Response To Therapy At Day 8 (Physician-Evaluated)
Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.
Time frame: Day 8
Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for response (physician-evaluated).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate (MF) | Response To Therapy At Day 8 (Physician-Evaluated) | 3.0 scores on a scale | Standard Deviation 1.2 |
| Beclomethasone Dipropionate (BDP) | Response To Therapy At Day 8 (Physician-Evaluated) | 2.7 scores on a scale | Standard Deviation 1.1 |
| Placebo | Response To Therapy At Day 8 (Physician-Evaluated) | 3.5 scores on a scale | Standard Deviation 1.1 |
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: <0.01ANOVA
Comparison: Pairwise treatment comparison based on t-test from an analysis of variance (ANOVA).p-value: 0.09ANOVA