Rhinitis, Allergic, Seasonal
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.
Interventions
DRUGMometasone furoate
Mometasone furoate nasal spray, 200 mg once daily
DRUGFluticasone propionate
Fluticasone propionate nasal spray, 200 mg once daily
DRUGMometasone furoate placebo
Mometasone furoate placebo matching nasal spray, once daily
Fluticasone propionate placebo matching nasal spray, once daily
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both participant and investigator were blinded to treatment identity. Because the mometasone furoate and fluticasone propionate bottles were not identical in appearance, a double-dummy study design was used and each bottle had a matching placebo. Thus, although participants received bottles of different appearance, they did not know whether bottles contained active substance or placebo.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 2-year history of seasonal allergic rhinitis * Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year) * 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 * Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study * Use of any chronic medication which could affect the course of seasonal allergic rhinitis * Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment) * Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip * Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior to Screening * Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator * Has rhinitis medicamentosa * Investigational drug use within the previous 30 days * Nasal structural abnormalities, including large nasal polyps and marked septal deviation, that significantly interfere with nasal air flow * Immunotherapy (desensitization therapy), unless on a stable maintenance schedule for at least one month prior to the Screening visit * History of multiple drug allergies, allergy to antihistamines or corticoids * History of psychosis, antagonistic personality, poor motivation, hypochondriasis, or any other emotional or intellectual problems that are likely to limit the validity of consent to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries) | Baseline and Day 1 through Day 15 (averaged over 15 days) | Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation) | Baseline (Day 1) and Day 15 | Change from baseline at Day 15 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation) | Baseline (Day 1) and Day 4 | Change from baseline at Day 4 was calculated for the Overall Condition of Seasonal Allergic Rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation) | Baseline (Day 1) and Day 15 | Change from baseline at Day 15 was calculated for the overall condition of seasonal allergic rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation) | Baseline (Day 1) and Day 4 | The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 4, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. |
| Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation) | Baseline (Day 1) and Day 4 | Change from baseline at Day 4 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. |
| Response to Therapy at Day 4 (Physician Evaluation) | Day 4 | Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 4. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms. |
| Response to Therapy at Day 15 (Physician Evaluation) | Day 15 | Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 15. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms. |
| Response to Therapy at Day 4 (Participant Evaluation) | Day 4 | Response to therapy was evaluated by participants and based upon their status scored at Day 4. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms. |
| Response to Therapy at Day 15 (Participant Evaluation) | Day 15 | Response to therapy was evaluated by participants and based upon their status scored at Day 15. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms. |
| Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation) | Baseline (Day 1) and Day 15 | The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 15, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Furoate Nasal Spray Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days. | 104 |
| Fluticasone Propionate Nasal Spray Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days. | 104 |
| Placebo Nasal Spray Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days. | 103 |
| Total | 311 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 2 | 2 |
| Overall Study | Did Not Meet Eligibility | 0 | 0 | 1 |
| Overall Study | Did Not Wish to Continue | 1 | 4 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
| Overall Study | Noncompliance With Protocol | 2 | 0 | 0 |
| Overall Study | Treatment Failure | 3 | 3 | 12 |
Baseline characteristics
| Characteristic | Mometasone Furoate Nasal Spray | Fluticasone Propionate Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|---|
| Age, Continuous | 31.72 Years STANDARD_DEVIATION 10.61 | 30.88 Years STANDARD_DEVIATION 10.71 | 31.14 Years STANDARD_DEVIATION 11.62 | 31.25 Years STANDARD_DEVIATION 10.54 |
| Sex: Female, Male Female | 49 Participants | 53 Participants | 39 Participants | 141 Participants |
| Sex: Female, Male Male | 55 Participants | 51 Participants | 64 Participants | 170 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 104 | 0 / 104 | 0 / 103 |
| other Total, other adverse events | 30 / 104 | 24 / 104 | 28 / 103 |
| serious Total, serious adverse events | 0 / 104 | 0 / 104 | 0 / 103 |
Outcome results
Primary
Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)
Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity.
Time frame: Baseline and Day 1 through Day 15 (averaged over 15 days)
Population: All randomized participants who completed at least one valid post-baseline visit and had available diary data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries) | -2.8 Score on a scale | Standard Deviation 2.2 |
| Fluticasone Propionate Nasal Spray | Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries) | -3.4 Score on a scale | Standard Deviation 2.3 |
| Placebo Nasal Spray | Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries) | -0.9 Score on a scale | Standard Deviation 2.3 |
p-value: <0.01ANOVA
p-value: <0.01ANOVA
p-value: 0.03ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)
The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 15, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time frame: Baseline (Day 1) and Day 15
Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Overall Condition of Seasonal Allergic Rhinitis (participant evaluation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation) | -1.1 Score on a scale | Standard Deviation 0.8 |
| Fluticasone Propionate Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation) | -1.3 Score on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation) | -0.5 Score on a scale | Standard Deviation 0.9 |
p-value: <0.01ANOVA
p-value: <0.01ANOVA
p-value: 0.06ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)
Change from baseline at Day 15 was calculated for the overall condition of seasonal allergic rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time frame: Baseline (Day 1) and Day 15
Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Overall Condition of Seasonal Allergic Rhinitis (physician evaluated)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation) | -0.9 Score on a scale | Standard Deviation 0.8 |
| Fluticasone Propionate Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation) | -1.2 Score on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation) | -0.5 Score on a scale | Standard Deviation 0.9 |
p-value: <0.01ANOVA
p-value: <0.01ANOVA
p-value: 0.01ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)
The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 4, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time frame: Baseline (Day 1) and Day 4
Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Overall Condition of Seasonal Allergic Rhinitis (participant evaluation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation) | -0.6 Score on a scale | Standard Deviation 0.8 |
| Fluticasone Propionate Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation) | -0.8 Score on a scale | Standard Deviation 0.7 |
| Placebo Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation) | -0.3 Score on a scale | Standard Deviation 0.8 |
p-value: 0.02ANOVA
p-value: <0.01ANOVA
p-value: 0.05ANOVA
Secondary
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)
Change from baseline at Day 4 was calculated for the Overall Condition of Seasonal Allergic Rhinitis, as assessed by the physician. The physician scored their overall condition on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time frame: Baseline (Day 1) and Day 4
Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Overall Condition of Seasonal Allergic Rhinitis (physician evaluated).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation) | -0.5 Score on a scale | Standard Deviation 0.7 |
| Fluticasone Propionate Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation) | -0.7 Score on a scale | Standard Deviation 0.8 |
| Placebo Nasal Spray | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation) | -0.3 Score on a scale | Standard Deviation 0.7 |
p-value: 0.08ANOVA
p-value: <0.01ANOVA
p-value: 0.1ANOVA
Secondary
Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)
Change from baseline at Day 15 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time frame: Baseline (Day 1) and Day 15
Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 15 visit data for Total Nasal Symptom Score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation) | -4.4 Score on a scale | Standard Deviation 2.9 |
| Fluticasone Propionate Nasal Spray | Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation) | -5.5 Score on a scale | Standard Deviation 2.7 |
| Placebo Nasal Spray | Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation) | -2.7 Score on a scale | Standard Deviation 3.3 |
p-value: <0.01ANOVA
p-value: <0.01ANOVA
p-value: 0.01ANOVA
Secondary
Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)
Change from baseline at Day 4 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.
Time frame: Baseline (Day 1) and Day 4
Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 4 visit data for Total Nasal Symptom Score.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation) | -3.2 Score on a scale | Standard Deviation 2.8 |
| Fluticasone Propionate Nasal Spray | Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation) | -3.5 Score on a scale | Standard Deviation 3 |
| Placebo Nasal Spray | Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation) | -1.8 Score on a scale | Standard Deviation 2.9 |
p-value: <0.01ANOVA
p-value: <0.01ANOVA
p-value: 0.31ANOVA
Secondary
Response to Therapy at Day 15 (Participant Evaluation)
Response to therapy was evaluated by participants and based upon their status scored at Day 15. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Time frame: Day 15
Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Response to Therapy (participant evaluation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Response to Therapy at Day 15 (Participant Evaluation) | 2.6 Score on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Response to Therapy at Day 15 (Participant Evaluation) | 2.4 Score on a scale | Standard Deviation 1.1 |
| Placebo Nasal Spray | Response to Therapy at Day 15 (Participant Evaluation) | 3.4 Score on a scale | Standard Deviation 1.3 |
p-value: <0.01ANOVA
p-value: <0.01ANOVA
p-value: 0.12ANOVA
Secondary
Response to Therapy at Day 15 (Physician Evaluation)
Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 15. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Time frame: Day 15
Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Response to Therapy (physician evaluation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Response to Therapy at Day 15 (Physician Evaluation) | 2.7 Score on a scale | Standard Deviation 1.1 |
| Fluticasone Propionate Nasal Spray | Response to Therapy at Day 15 (Physician Evaluation) | 2.4 Score on a scale | Standard Deviation 1.1 |
| Placebo Nasal Spray | Response to Therapy at Day 15 (Physician Evaluation) | 3.2 Score on a scale | Standard Deviation 1.3 |
p-value: <0.01ANOVA
p-value: <0.01ANOVA
p-value: 0.07ANOVA
Secondary
Response to Therapy at Day 4 (Participant Evaluation)
Response to therapy was evaluated by participants and based upon their status scored at Day 4. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Time frame: Day 4
Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Response to Therapy (participant evaluation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Response to Therapy at Day 4 (Participant Evaluation) | 3.2 Score on a scale | Standard Deviation 0.9 |
| Fluticasone Propionate Nasal Spray | Response to Therapy at Day 4 (Participant Evaluation) | 3.1 Score on a scale | Standard Deviation 1.1 |
| Placebo Nasal Spray | Response to Therapy at Day 4 (Participant Evaluation) | 3.7 Score on a scale | Standard Deviation 1.1 |
p-value: <0.01ANOVA
p-value: <0.01ANOVA
p-value: 0.53ANOVA
Secondary
Response to Therapy at Day 4 (Physician Evaluation)
Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 4. The physician evaluated the participant's response using the following 5-point scale: 1=complete relief, 2=marked relief, 3=moderate relief, 4=slight relief, and 5=no relief. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.
Time frame: Day 4
Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Response to Therapy (physician evaluation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Response to Therapy at Day 4 (Physician Evaluation) | 3.2 Score on a scale | Standard Deviation 0.9 |
| Fluticasone Propionate Nasal Spray | Response to Therapy at Day 4 (Physician Evaluation) | 3.1 Score on a scale | Standard Deviation 1.1 |
| Placebo Nasal Spray | Response to Therapy at Day 4 (Physician Evaluation) | 3.8 Score on a scale | Standard Deviation 1 |
p-value: <0.01ANOVA
p-value: <0.01ANOVA
p-value: 0.46ANOVA