Dose-Ranging Study of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray in the Treatment of Children (Ages 6-11) With Seasonal Allergic Rhinitis (C95-161)

The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

The mean change from baseline at study day 4 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

The mean change from baseline at study day 15 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

The mean change from baseline at study day 29 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.

Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.

Mean change from baseline (CFB) averaged over study days 1-15 was calculated for TNSS assessed by participants (with assistance from caregiver). Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in diaries using the scale 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) CFD=the 15-day average score-baseline score. Scores were recorded twice daily, in the morning (AM) and evening (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score were calculated, the total 15-day average score was not calculated. Baseline score=Mean of the Baseline AM (day of visit plus 3 preceding days) and the Baseline PM (3 preceding days) scores. Negative change indicated a decrease in symptom severity.