Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.

Time frame: Baseline and days 1 through 15 (average of 15 days of treatment)

Population: Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average.

Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.

Time frame: Baseline and days 1 through 15 (average of 15 days of treatment)

Population: Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average.

The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.

Time frame: Baseline and study day 15

Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.

The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.

Time frame: Baseline and study day 8

Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.

The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.

Time frame: Baseline and study day 15

Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.

The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.

Time frame: Baseline and study day 8

Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.

The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.

Time frame: Baseline and study day 15

Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.

The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity.

Time frame: Baseline and study day 8

Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.

Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response.

Time frame: Study day 15

Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.

Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response.

Time frame: Study day 8

Population: All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment.