Trial Outcomes & Findings for Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184) (NCT NCT03861559)

NCT ID: NCT03861559

Last Updated: 2022-02-09

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 201 participants
• Primary outcome timeframe: From the start of treatment until onset of symptom relief (up to Day 4)
• Results posted on: 2022-02-09

Participant Flow

A total of 201 participants were randomized into the study (101 mometasone furoate; 100 placebo).

Participant milestones

Measure	Mometasone Furoate Nasal Spray Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Overall Study STARTED	101	100
Overall Study COMPLETED	99	95
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Measure	Mometasone Furoate Nasal Spray Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Overall Study Adverse Event	0	2
Overall Study Treatment failure	0	2
Overall Study Noncompliance	1	1
Overall Study Did not meet eligibility requirements	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Mometasone Furoate Nasal Spray n=101 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=100 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.	Total n=201 Participants Total of all reporting groups
Age, Continuous	31.1 Years STANDARD_DEVIATION 10.1 • n=93 Participants	31.8 Years STANDARD_DEVIATION 10.9 • n=4 Participants	31.4 Years STANDARD_DEVIATION 10.5 • n=27 Participants
Sex: Female, Male Female	60 Participants n=93 Participants	51 Participants n=4 Participants	111 Participants n=27 Participants
Sex: Female, Male Male	41 Participants n=93 Participants	49 Participants n=4 Participants	90 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	9 Participants n=93 Participants	10 Participants n=4 Participants	19 Participants n=27 Participants
Race (NIH/OMB) White	88 Participants n=93 Participants	88 Participants n=4 Participants	176 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	2 Participants n=4 Participants	6 Participants n=27 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=76 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=49 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Median Time to Onset of Nasal Symptom Relief as Assessed by Participant Diary Responses	35.9 Hours Interval 0.5 to 72.0	72.0 Hours Interval 0.25 to 72.0

SECONDARY outcome

Timeframe: 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, 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=98 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=98 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) Averaged Over 15 Days of Treatment, as Assessed by Participant	-39 Percent change Standard Deviation 2.0	-20 Percent change Standard Deviation 25.8

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=99 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=95 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 4 as Assessed by Investigator	-34 Percent change Standard Deviation 28.8	-16 Percent change Standard Deviation 29.8

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=98 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=94 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 8 as Assessed by Investigator	-44 Percent change Standard Deviation 33.4	-28 Percent change Standard Deviation 34.2

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=99 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=98 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Change From Baseline (CFB) in the Total Nasal Symptom Score (TNSS) at Day 15 as Assessed by Investigator	-43 Percent change Standard Deviation 33.8	-27 Percent change Standard Deviation 34.2

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=99 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=95 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Investigator	-22 Percent change Standard Deviation 30	-16 Percent change Standard Deviation 32.5

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=98 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=95 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Investigator	-34 Percent change Standard Deviation 35.5	-22 Percent change Standard Deviation 33.2

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=95 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=94 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Change From Baseline in Overall Disease Condition Score at Day 15 as Assessed by Investigator	-41 Percent change Standard Deviation 31.8	-18 Percent change Standard Deviation 30.7

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=99 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=94 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Change From Baseline (CFB) in Overall Disease Condition Score at Day 4 as Assessed by Participant	-24 Percent change Standard Deviation 33.5	-18 Percent change Standard Deviation 33.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=98 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=95 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Change From Baseline (CFB) in Overall Disease Condition Score at Day 8 as Assessed by Participant	-36 Percent change Standard Deviation 34.0	-21 Percent change Standard Deviation 38.2

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=95 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=94 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Change From Baseline (CFB) in Overall Disease Condition Score at Day 15 as Assessed by Participant	-41 Percent change Standard Deviation 34.5	-21 Percent change Standard Deviation 37.0

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=99 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=95 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Therapeutic Response to Treatment at Day 4 as Assessed by Investigator	3.2 Score on a scale Standard Deviation 1.0	3.8 Score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=98 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=95 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Therapeutic Response to Treatment at Day 8 as Assessed by Investigator	2.9 Score on a scale Standard Deviation 1.1	3.5 Score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=95 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=94 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Therapeutic Response to Treatment at Day 15 as Assessed by Investigator	2.7 Score on a scale Standard Deviation 1.1	3.7 Score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=99 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=94 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Therapeutic Response to Treatment at Day 4 as Assessed by Participant	3.2 Score on a scale Standard Deviation 1.0	3.8 Score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=98 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=95 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Therapeutic Response to Treatment at Day 8 as Assessed by Participant	2.9 Score on a scale Standard Deviation 1.2	3.6 Score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=95 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=94 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Therapeutic Response to Treatment at Day 15 as Assessed by Participant	2.8 Score on a scale Standard Deviation 1.1	3.6 Score on a scale Standard Deviation 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=98 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=98 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline Averaged Over 15 Days of Treatment as Assessed by Participant	8.4 Score on a scale Standard Deviation 1.9	8.6 Score on a scale Standard Deviation 1.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=99 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=98 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Baseline Total Nasal Symptom Score (TNSS) for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator	8.9 Score on a scale Standard Deviation 1.4	8.9 Score on a scale Standard Deviation 1.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=99 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=98 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Baseline Overall Disease Condition Score for Calculation of Change From Baseline at Days 4, 8, and 15 Visits as Assessed by Investigator	2.3 Score on a scale Standard Deviation 0.5	2.3 Score on a scale Standard Deviation 0.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (Day 1)

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

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.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=99 Participants Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=98 Participants Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Baseline Overall Disease Condition Score for Calculation of Change From Baseline at Days 4, 8, and 15 as Assessed by Participant	2.4 Score on a scale Standard Deviation 0.5	2.4 Score on a scale Standard Deviation 0.5

Adverse Events

Mometasone Furoate Nasal Spray

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Placebo Nasal Spray

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mometasone Furoate Nasal Spray n=101 participants at risk Participants administered mometasone furoate nasal spray 200 mcg QD, as two 50 mcg sprays per nostril, for 14 consecutive days.	Placebo Nasal Spray n=99 participants at risk Participants administered placebo nasal spray QD, as two placebo sprays per nostril, for 14 consecutive days.
Nervous system disorders Headache	13.9% 14/101 • Number of events 19 • Baseline (Day 1) and up to 14 days after study completion/discontinuation for non-serious adverse events and up to an additional 30 days after study completion for serious adverse events (up to 45 days). All participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.	13.1% 13/99 • Number of events 19 • Baseline (Day 1) and up to 14 days after study completion/discontinuation for non-serious adverse events and up to an additional 30 days after study completion for serious adverse events (up to 45 days). All participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The principal investigator and his co-workers agree not to publish or publicly present any results of the study without the prior written consent and approval of the sponsor.
• Publication restrictions are in place

Restriction type: OTHER