Trial Outcomes & Findings for Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013) (NCT NCT03855189)

NCT ID: NCT03855189

Last Updated: 2022-02-09

Results Overview

TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching, as rated in their diary in the morning (AM) and evening (PM). The 4 individual symptom scores rated as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For the 15 day interval, participant individual daily scores were totaled and averaged over interval (AM and PM computed separately then averaged) and used to calculate the overall average change from Baseline. Participant average changes were then used to calculate the mean change for each arm for the interval. Average change from Baseline for Days 1-15 = average post-treatment score (Days 1-15) - Baseline average score (average of the Baseline AM/PM diary scores from 3 consecutive days prior to Baseline visit). Negative changes from baseline indicate a decrease in symptom severity.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 345 participants
• Primary outcome timeframe: Baseline, and Days 1 through 15 (average of 15 days of treatment)
• Results posted on: 2022-02-09

Participant Flow

Participant milestones

Measure	Mometasone Furoate (MF) Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Study STARTED	113	116	116
Overall Study Treated	112	116	116
Overall Study COMPLETED	103	109	110
Overall Study NOT COMPLETED	10	7	6

Reasons for withdrawal

Measure	Mometasone Furoate (MF) Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Overall Study Adverse Event	5	2	4
Overall Study Treatment Failure	1	1	2
Overall Study Noncompliance with Protocol	0	1	0
Overall Study Did Not Return	4	3	0

Baseline Characteristics

Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013)

Baseline characteristics by cohort

Measure	Mometasone Furoate (MF) n=113 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=116 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.	Total n=345 Participants Total of all reporting groups
Age, Continuous	34.8 Years STANDARD_DEVIATION 12.3 • n=5 Participants	34.6 Years STANDARD_DEVIATION 12.1 • n=7 Participants	35.5 Years STANDARD_DEVIATION 11.2 • n=5 Participants	34.9 Years STANDARD_DEVIATION 11.8 • n=4 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	52 Participants n=7 Participants	72 Participants n=5 Participants	176 Participants n=4 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	64 Participants n=7 Participants	44 Participants n=5 Participants	169 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, and Days 1 through 15 (average of 15 days of treatment)

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available diary data.

TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching, as rated in their diary in the morning (AM) and evening (PM). The 4 individual symptom scores rated as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For the 15 day interval, participant individual daily scores were totaled and averaged over interval (AM and PM computed separately then averaged) and used to calculate the overall average change from Baseline. Participant average changes were then used to calculate the mean change for each arm for the interval. Average change from Baseline for Days 1-15 = average post-treatment score (Days 1-15) - Baseline average score (average of the Baseline AM/PM diary scores from 3 consecutive days prior to Baseline visit). Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated) Baseline	7.6 score on a scale Standard Deviation 2.2	7.3 score on a scale Standard Deviation 2.2	7.6 score on a scale Standard Deviation 2.0
Change From Baseline in the Total Nasal Symptom Score (TNSS) (Average of Morning [AM]/Evening [PM] Score) Averaged Over Days 1 to 15 (Participant-Evaluated) Change from Baseline Days 1-15	-2.3 score on a scale Standard Deviation 2.7	-2.8 score on a scale Standard Deviation 2.1	-1.5 score on a scale Standard Deviation 2.1

PRIMARY outcome

Timeframe: Up to 31 Days

Population: All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants with at least one AE was reported for each treatment group.

Outcome measures

Measure	Mometasone Furoate (MF) n=112 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=116 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Number of Participants Who Experienced ≥1 Adverse Event	60 Participants	64 Participants	78 Participants

PRIMARY outcome

Timeframe: Up to 31 Days

Population: All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who discontinued due to an AE was reported for each treatment group.

Outcome measures

Measure	Mometasone Furoate (MF) n=112 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=116 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Number of Participants Who Discontinued Treatment Due to An Adverse Event (AE)	5 Participants	2 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 4

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for TNSS.

TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in the TNSS At Day 4 (Physician-Evaluated) Change From Baseline Day 4	-2.4 scores on a scale Standard Deviation 2.8	-2.7 scores on a scale Standard Deviation 2.2	-1.8 scores on a scale Standard Deviation 2.5
Change From Baseline in the TNSS At Day 4 (Physician-Evaluated) Baseline	8.3 scores on a scale Standard Deviation 1.7	7.9 scores on a scale Standard Deviation 1.7	8.4 scores on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 8

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for TNSS.

TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in the TNSS At Day 8 (Physician-Evaluated) Baseline	8.3 scores on a scale Standard Deviation 1.7	7.9 scores on a scale Standard Deviation 1.7	8.4 scores on a scale Standard Deviation 1.6
Change From Baseline in the TNSS At Day 8 (Physician-Evaluated) Change From Baseline Day 8	-3.3 scores on a scale Standard Deviation 2.9	-3.8 scores on a scale Standard Deviation 2.3	-1.9 scores on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 15

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for TNSS.

TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in the TNSS At Day 15 (Physician-Evaluated) Baseline	8.3 scores on a scale Standard Deviation 1.7	7.9 scores on a scale Standard Deviation 1.7	8.4 scores on a scale Standard Deviation 1.6
Change From Baseline in the TNSS At Day 15 (Physician-Evaluated) Change From Baseline Day 15	-3.3 scores on a scale Standard Deviation 2.9	-3.8 scores on a scale Standard Deviation 2.7	-2.6 scores on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 22

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for TNSS.

TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in the TNSS At Day 22 (Physician-Evaluated) Baseline	8.3 scores on a scale Standard Deviation 1.7	7.9 scores on a scale Standard Deviation 1.7	8.4 scores on a scale Standard Deviation 1.6
Change From Baseline in the TNSS At Day 22 (Physician-Evaluated) Change From Baseline Day 22	-3.9 scores on a scale Standard Deviation 2.9	-4.0 scores on a scale Standard Deviation 2.7	-3.2 scores on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 29

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for TNSS.

TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual symptom scores were rated by the physician at the visit as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual 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 from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in the TNSS At Day 29 (Physician-Evaluated) Baseline	8.3 scores on a scale Standard Deviation 1.7	7.9 scores on a scale Standard Deviation 1.7	8.4 scores on a scale Standard Deviation 1.6
Change From Baseline in the TNSS At Day 29 (Physician-Evaluated) Change From Baseline Day 29	-4.1 scores on a scale Standard Deviation 2.9	-4.6 scores on a scale Standard Deviation 2.6	-3.2 scores on a scale Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 4

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for SAR overall condition (physician-evaluated).

Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated) Baseline	2.3 scores on a scale Standard Deviation 0.5	2.2 scores on a scale Standard Deviation 0.4	2.2 scores on a scale Standard Deviation 0.1
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Physician-Evaluated) Change From Baseline Day 4	-0.6 scores on a scale Standard Deviation 0.7	-0.5 scores on a scale Standard Deviation 0.7	-0.3 scores on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 8

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for SAR overall condition (physician-evaluated).

Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated) Baseline	2.3 scores on a scale Standard Deviation 0.5	2.2 scores on a scale Standard Deviation 0.4	2.2 scores on a scale Standard Deviation 0.1
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Physician-Evaluated) Change From Baseline Day 8	-0.7 scores on a scale Standard Deviation 0.8	-0.8 scores on a scale Standard Deviation 0.7	-0.3 scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 15

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for SAR overall condition (physician-evaluated).

Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated) Baseline	2.3 scores on a scale Standard Deviation 0.5	2.2 scores on a scale Standard Deviation 0.4	2.2 scores on a scale Standard Deviation 0.1
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Physician-Evaluated) Change From Baseline Day 15	-0.7 scores on a scale Standard Deviation 0.8	-0.8 scores on a scale Standard Deviation 0.7	-0.5 scores on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 22

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for SAR overall condition (physician-evaluated).

Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated) Baseline	2.3 scores on a scale Standard Deviation 0.5	2.2 scores on a scale Standard Deviation 0.4	2.2 scores on a scale Standard Deviation 0.1
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Physician-Evaluated) Change From Baseline Day 22	-0.9 scores on a scale Standard Deviation 0.8	-0.8 scores on a scale Standard Deviation 0.7	-0.6 scores on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 29

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for SAR overall condition (physician-evaluated).

Overall condition of seasonal allergic rhinitis was evaluated by the physician during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated) Baseline	2.3 scores on a scale Standard Deviation 0.5	2.2 scores on a scale Standard Deviation 0.4	2.2 scores on a scale Standard Deviation 0.1
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Physician-Evaluated) Change From Baseline Day 29	-0.9 scores on a scale Standard Deviation 0.9	-0.9 scores on a scale Standard Deviation 0.8	-0.6 scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 4

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for SAR overall condition (participant-evaluated).

Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated) Baseline	2.2 scores on a scale Standard Deviation 0.5	2.2 scores on a scale Standard Deviation 0.5	2.3 scores on a scale Standard Deviation 0.5
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 4 (Participant-Evaluated) Change From Baseline Day 4	-0.6 scores on a scale Standard Deviation 0.8	-0.6 scores on a scale Standard Deviation 0.6	-0.4 scores on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 8

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for SAR overall condition (participant-evaluated).

Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated) Baseline	2.2 scores on a scale Standard Deviation 0.5	2.2 scores on a scale Standard Deviation 0.5	2.3 scores on a scale Standard Deviation 0.5
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 8 (Participant-Evaluated) Change From Baseline Day 8	-0.7 scores on a scale Standard Deviation 0.8	-0.8 scores on a scale Standard Deviation 0.7	-0.4 scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 15

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for SAR overall condition (participant-evaluated).

Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated) Baseline	2.2 scores on a scale Standard Deviation 0.5	2.2 scores on a scale Standard Deviation 0.5	2.3 scores on a scale Standard Deviation 0.5
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 15 (Participant-Evaluated) Change From Baseline Day 15	-0.7 scores on a scale Standard Deviation 0.8	-0.8 scores on a scale Standard Deviation 0.8	-0.5 scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 22

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for SAR overall condition (participant-evaluated).

Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated) Baseline	2.2 scores on a scale Standard Deviation 0.5	2.2 scores on a scale Standard Deviation 0.5	2.3 scores on a scale Standard Deviation 0.5
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 22 (Participant-Evaluated) Change From Baseline Day 22	-0.9 scores on a scale Standard Deviation 0.8	-0.9 scores on a scale Standard Deviation 0.8	-0.7 scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline (Day 1), Day 29

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for SAR overall condition (participant-evaluated).

Overall condition of seasonal allergic rhinitis was evaluated by the participant during the visit and scored on a scale from 0 to 3 as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. A higher score indicated more frequent/severe nasal symptoms. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes from baseline indicate a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate (MF) n=111 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated) Baseline	2.2 scores on a scale Standard Deviation 0.5	2.2 scores on a scale Standard Deviation 0.5	2.3 scores on a scale Standard Deviation 0.5
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis At Day 29 (Participant-Evaluated) Change From Baseline Day 29	-0.9 scores on a scale Standard Deviation 0.9	-0.9 scores on a scale Standard Deviation 0.7	-0.6 scores on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Day 4

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for response (physician-evaluated).

Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.

Outcome measures

Measure	Mometasone Furoate (MF) n=110 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Response To Therapy At Day 4 (Physician-Evaluated)	3.3 scores on a scale Standard Deviation 1.2	3.2 scores on a scale Standard Deviation 1.1	3.5 scores on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Day 8

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for response (physician-evaluated).

Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.

Outcome measures

Measure	Mometasone Furoate (MF) n=110 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=113 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Response To Therapy At Day 8 (Physician-Evaluated)	3.0 scores on a scale Standard Deviation 1.2	2.7 scores on a scale Standard Deviation 1.1	3.5 scores on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Day 15

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for response (physician-evaluated).

Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.

Outcome measures

Measure	Mometasone Furoate (MF) n=107 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=111 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=112 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Response To Therapy At Day 15 (Physician-Evaluated)	3.0 scores on a scale Standard Deviation 1.1	2.8 scores on a scale Standard Deviation 1.0	3.3 scores on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Day 22

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for response (physician-evaluated).

Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.

Outcome measures

Measure	Mometasone Furoate (MF) n=105 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=110 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=109 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Response To Therapy At Day 22 (Physician-Evaluated)	2.8 scores on a scale Standard Deviation 1.1	2.7 scores on a scale Standard Deviation 1.1	3.1 scores on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Day 29

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for response (physician-evaluated).

Response to therapy was evaluated by the physician and based upon the participant's status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.

Outcome measures

Measure	Mometasone Furoate (MF) n=100 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=105 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=105 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Response To Therapy At Day 29 (Physician-Evaluated)	2.9 scores on a scale Standard Deviation 1.2	2.5 scores on a scale Standard Deviation 1.2	3.2 scores on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Day 4

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 4 visit data for response (participant-evaluated).

Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.

Outcome measures

Measure	Mometasone Furoate (MF) n=110 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Response To Therapy At Day 4 (Participant-Evaluated)	3.3 scores on a scale Standard Deviation 1.0	3.2 scores on a scale Standard Deviation 0.9	3.6 scores on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Day 8

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 8 visit data for response (participant-evaluated).

Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.

Outcome measures

Measure	Mometasone Furoate (MF) n=110 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=113 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=113 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Response To Therapy At Day 8 (Participant-Evaluated)	3.0 scores on a scale Standard Deviation 1.0	2.7 scores on a scale Standard Deviation 1.0	3.5 scores on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Day 15

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 15 visit data for response (participant-evaluated).

Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.

Outcome measures

Measure	Mometasone Furoate (MF) n=107 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=111 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=112 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Response To Therapy At Day 15 (Participant-Evaluated)	3.0 scores on a scale Standard Deviation 1.1	2.7 scores on a scale Standard Deviation 0.9	3.3 scores on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Day 22

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 22 visit data for response (participant-evaluated).

Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.

Outcome measures

Measure	Mometasone Furoate (MF) n=105 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=110 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=109 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Response To Therapy At Day 22 (Participant-Evaluated)	2.9 scores on a scale Standard Deviation 1.1	2.7 scores on a scale Standard Deviation 1.1	3.1 scores on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Day 29

Population: All randomized participants who met eligibility criteria and evaluability criteria, completed at least one valid post-Baseline visit, and had available Day 29 visit data for response (participant-evaluated).

Response to therapy was evaluated by the participant and based upon their status scored relative to Baseline. Response was scored on a scale from 1 to 5 as follows: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. A higher score indicated a weaker response.

Outcome measures

Measure	Mometasone Furoate (MF) n=100 Participants Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=105 Participants Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=104 Participants Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Response To Therapy At Day 29 (Participant-Evaluated)	2.9 scores on a scale Standard Deviation 1.1	2.6 scores on a scale Standard Deviation 1.1	3.3 scores on a scale Standard Deviation 1.1

Adverse Events

Mometasone Furoate (MF)

Serious events: 0 serious events

Other events: 47 other events

Deaths: 0 deaths

Beclomethasone Dipropionate (BDP)

Serious events: 0 serious events

Other events: 38 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mometasone Furoate (MF) n=112 participants at risk Participants received 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days.	Beclomethasone Dipropionate (BDP) n=116 participants at risk Participants received 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days.	Placebo n=116 participants at risk Participants received nasal placebo in the morning upon awakening and again approximately 12 hours later in the evening for 29 days.
Infections and infestations NASOPHARYNGITIS	3.6% 4/112 • Number of events 4 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	2.6% 3/116 • Number of events 6 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	5.2% 6/116 • Number of events 13 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.
Nervous system disorders HEADACHE	25.9% 29/112 • Number of events 59 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	23.3% 27/116 • Number of events 49 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	25.9% 30/116 • Number of events 66 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.
Nervous system disorders SINUS HEADACHE	9.8% 11/112 • Number of events 14 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	5.2% 6/116 • Number of events 8 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	5.2% 6/116 • Number of events 10 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.
Respiratory, thoracic and mediastinal disorders NASAL DISCOMFORT	3.6% 4/112 • Number of events 8 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	5.2% 6/116 • Number of events 15 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	10.3% 12/116 • Number of events 28 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	6.2% 7/112 • Number of events 14 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	5.2% 6/116 • Number of events 11 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	5.2% 6/116 • Number of events 9 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.
Respiratory, thoracic and mediastinal disorders SNEEZING	0.00% 0/112 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	0.86% 1/116 • Number of events 2 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed for safety.	6.9% 8/116 • Number of events 23 • Up to 31 Days All randomized participants who received at least one dose of study medication and had at least one post-Baseline evaluation were analyzed 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 Sponsor has 30 days prior to submission for publication or presentation to review copies of abstracts or manuscripts for publication (including texts of oral presentations) which report any results of the Protocol study. Sponsor shall have editorial rights with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation with regard to proprietary information and the accuracy of the information contained in the publication.
• Publication restrictions are in place

Restriction type: OTHER