Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)

Time to onset of relief of nasal stuffiness/congestion, rhinorrhea, nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears or palate was assessed by the participant using diary response data in the morning and night for the first 3 days of treatment. The participants were asked to rate their relief on the following scale: 1=complete, 2=marked, 3=moderate, 4=slight, and 5=none. If a participant recorded a degree of relief that was at least moderate (3 or below), they answered the question, When did you first experience noticeable relief? and noted the date and time. The data were analyzed using a log ranked test and with a Kaplan-Meier estimate. Any participant who did not experience at least moderate relief by the end of 72 hours was considered censored at that time in the analysis. Time to onset of relief is presented in hours.

Time frame: From the start of treatment until onset of symptom relief (up to Day 4)

Population: Included randomized participants with ≥1 valid post-baseline visit, had evaluable data for the endpoint, and experienced at least moderate relief by the end of 72 hours of treatment.

CFB on study Day 15 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant 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. Percent CFB was calculated as the difference between the baseline and Day 15 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 15

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

CFB on study Day 4 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 4 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 4

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

CFB on study Day 4 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant 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. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 4

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

CFB on study Day 8 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 8

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

CFB on study Day 8 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the participant. The participant scored their overall condition on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 8

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

CFB at Day 15 was calculated for TNSS assessed by the investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and endpoint scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.

Time frame: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

CFB on study Day 4 was calculated for TNSS assessed by investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on study Day 4, on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 4 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 4

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

CFB on study Day 8 was calculated for TNSS assessed by investigator. TNSS was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The investigator scored each symptom during study visit on study Day 8 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 8 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms.

Time frame: Baseline (Day 1) and Day 8

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

CFB, averaged over study days 1-15, was calculated for TNSS assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries using the scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. A decrease in symptom severity is reflected by a negative CFB. Percent CFB was calculated as the difference between the baseline and 15-day average scores divided by baseline score multiplied by 100. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores were 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 was an average of the three AM and three PM scores preceding treatment.

Time frame: Baseline (3 days preceding treatment) through Day 15 (averaged over 15 days)

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed. Baseline data was missing for 1 participant in the mometasone furoate nasal spray group for this endpoint and the participant was excluded from the analysis.

CFB on study Day 15 was calculated for the overall condition of seasonal allergic rhinitis as assessed by the investigator. The investigator scored the overall condition of the participant during the study visit on study Day 15 on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. Percent CFB was calculated as the difference between the baseline and Day 15 scores divided by baseline score multiplied by 100. A negative percent CFB indicated a decrease in symptom severity and a positive percent CFB indicated a worsening of symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.

Time frame: Baseline (Day 1) and Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 15. Treatment response was evaluated by the investigator using a 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 treatment and an improvement in nasal symptoms. Signs and symptoms data collected by the investigator for Day 15 were not evaluated because the data was missing from the case report forms. The final endpoint was calculated using the last valid visit for each participant.

Time frame: Final Endpoint (Up to Day 15). The final endpoint was calculated using the last valid visit for each participant due to missing data at Day 15.

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 15. Treatment response was evaluated by the participant using a 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 treatment and an improvement in nasal symptoms.

Time frame: Day 15

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 4. Treatment response was evaluated by the investigator using a 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 treatment and an improvement in nasal symptoms.

Time frame: Day 4

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 4. Treatment response was evaluated by the participant using a 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 treatment and an improvement in nasal symptoms.

Time frame: Day 4

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

Mean therapeutic response to treatment was assessed by evaluating the participant's relief of nasal symptoms during study visit on study Day 8. Treatment response was evaluated by the investigator using a 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 treatment and an improvement in nasal symptoms.

Time frame: Day 8

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

Mean therapeutic response to treatment was assessed by the participant using diary cards on Day 8. Treatment response was evaluated by the participant using a 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 treatment and an improvement in nasal symptoms.

Time frame: Day 8

Population: All randomized participants who took ≥1 dose of study medication, had ≥1 baseline endpoint observation, had ≥1 post-baseline visit, and evaluable data for the endpoint being analyzed.

The participant scored the overall condition of seasonal allergic rhinitis in a diary using the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. The baseline score was recorded preceding treatment.

Time frame: Baseline (Day 1)

Population: All randomized participants who took ≥1 dose of study medication and provided at least 1 baseline endpoint observation

The investigator scored the overall condition of seasonal allergic rhinitis for the participant during the study visits using the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity. The baseline score was taken at the baseline visit preceding treatment.

Time frame: Baseline (Day 1)

Population: All randomized participants who took ≥1 dose of study medication and provided at least 1 baseline endpoint observation

TNSS was assessed by the investigator who scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries using the scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. The baseline score was taken at the baseline visit preceding treatment.

Time frame: Baseline (Day 1)

Population: All randomized participants who took ≥1 dose of study medication and provided at least 1 baseline endpoint observation.

TNSS was assessed by participants who scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries using the scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12 where a higher value indicated greater severity. Scores were recorded twice daily, in morning (AM) and night (PM). The baseline score was an average of the three AM and three PM scores preceding treatment.

Time frame: Baseline (3 days preceding treatment)

Population: All randomized participants who took ≥1 dose of study medication and provided ≥1 baseline endpoint observation for the calculation of the CFB in TNSS averaged over 15 days. Baseline data was missing for 1 participant in the mometasone furoate nasal spray group for this endpoint and the participant was excluded from the analysis.