Trial Outcomes & Findings for Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001) (NCT NCT03882047)

NCT ID: NCT03882047

Last Updated: 2022-02-09

Results Overview

Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 313 participants
• Primary outcome timeframe: Baseline and Day 1 through Day 15 (averaged over 15 days)
• Results posted on: 2022-02-09

Participant Flow

Participant milestones

Measure	Mometasone Furoate Nasal Spray Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Study STARTED	104	105	104
Overall Study Treated	104	104	103
Overall Study COMPLETED	98	95	88
Overall Study NOT COMPLETED	6	10	16

Reasons for withdrawal

Measure	Mometasone Furoate Nasal Spray Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Overall Study Adverse Event	0	2	2
Overall Study Treatment Failure	3	3	12
Overall Study Lost to Follow-up	0	1	0
Overall Study Did Not Wish to Continue	1	4	1
Overall Study Noncompliance With Protocol	2	0	0
Overall Study Did Not Meet Eligibility	0	0	1

Baseline Characteristics

Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)

Baseline characteristics by cohort

Measure	Mometasone Furoate Nasal Spray n=104 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=104 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=103 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Total n=311 Participants Total of all reporting groups
Age, Continuous	31.72 Years STANDARD_DEVIATION 10.61 • n=5 Participants	30.88 Years STANDARD_DEVIATION 10.71 • n=7 Participants	31.14 Years STANDARD_DEVIATION 11.62 • n=5 Participants	31.25 Years STANDARD_DEVIATION 10.54 • n=4 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	53 Participants n=7 Participants	39 Participants n=5 Participants	141 Participants n=4 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	51 Participants n=7 Participants	64 Participants n=5 Participants	170 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and Day 1 through Day 15 (averaged over 15 days)

Population: All randomized participants who completed at least one valid post-baseline visit and had available diary data.

Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=104 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=104 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=103 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Change From Baseline in Total Nasal Symptom Score Averaged Over Day 1 Through Day 15 (Based on Participant Diaries)	-2.8 Score on a scale Standard Deviation 2.2	-3.4 Score on a scale Standard Deviation 2.3	-0.9 Score on a scale Standard Deviation 2.3

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 4

Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 4 visit data for Total Nasal Symptom Score.

Change from baseline at Day 4 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=103 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=104 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=103 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Change From Baseline in the Total Nasal Symptom Score at Day 4 (Physician Evaluation)	-3.2 Score on a scale Standard Deviation 2.8	-3.5 Score on a scale Standard Deviation 3.0	-1.8 Score on a scale Standard Deviation 2.9

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 15

Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 15 visit data for Total Nasal Symptom Score.

Change from baseline at Day 15 was calculated for the Total Nasal Symptom Score, as assessed by the physician. The Total Nasal Symptom Score was a composite of the following symptoms: rhinorrhea, nasal stuffiness, nasal itching, and sneezing scores. The physician scored each symptom during the study visit on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. The composite score ranged from 0-12. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=95 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=95 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=88 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Change From Baseline in the Total Nasal Symptom Score at Day 15 (Physician Evaluation)	-4.4 Score on a scale Standard Deviation 2.9	-5.5 Score on a scale Standard Deviation 2.7	-2.7 Score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 4

Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Overall Condition of Seasonal Allergic Rhinitis (physician evaluated).

Change from baseline at Day 4 was calculated for the Overall Condition of Seasonal Allergic Rhinitis, as assessed by the physician. The physician 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 of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=103 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=104 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=103 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Physician Evaluation)	-0.5 Score on a scale Standard Deviation 0.7	-0.7 Score on a scale Standard Deviation 0.8	-0.3 Score on a scale Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 15

Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Overall Condition of Seasonal Allergic Rhinitis (physician evaluated)

Change from baseline at Day 15 was calculated for the overall condition of seasonal allergic rhinitis, as assessed by the physician. The physician 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 of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=95 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=95 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=88 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Physician Evaluation)	-0.9 Score on a scale Standard Deviation 0.8	-1.2 Score on a scale Standard Deviation 0.8	-0.5 Score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 4

Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Overall Condition of Seasonal Allergic Rhinitis (participant evaluation).

The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 4, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=103 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=104 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=103 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 4 (Participant Evaluation)	-0.6 Score on a scale Standard Deviation 0.8	-0.8 Score on a scale Standard Deviation 0.7	-0.3 Score on a scale Standard Deviation 0.8

SECONDARY outcome

Timeframe: Baseline (Day 1) and Day 15

Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Overall Condition of Seasonal Allergic Rhinitis (participant evaluation)

The overall condition of seasonal allergic rhinitis was evaluated by the participant on Day 15, based on the following scale: 0=none, 1=mild, 2=moderate; and 3=severe. A higher value indicated greater severity of symptoms. Change from baseline = visit score - baseline score (Day 1 visit). A negative change from baseline score indicated a decrease in symptom severity.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=95 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=95 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=88 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis at Day 15 (Participant Evaluation)	-1.1 Score on a scale Standard Deviation 0.8	-1.3 Score on a scale Standard Deviation 0.8	-0.5 Score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: Day 4

Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Response to Therapy (physician evaluation).

Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 4. The physician evaluated the participant's response using the following 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 therapy and an improvement in nasal symptoms.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=103 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=104 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=103 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Response to Therapy at Day 4 (Physician Evaluation)	3.2 Score on a scale Standard Deviation 0.9	3.1 Score on a scale Standard Deviation 1.1	3.8 Score on a scale Standard Deviation 1.0

SECONDARY outcome

Timeframe: Day 15

Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Response to Therapy (physician evaluation).

Response to therapy was assessed by evaluating the participant's relief of nasal symptoms at Day 15. The physician evaluated the participant's response using the following 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 therapy and an improvement in nasal symptoms.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=95 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=95 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=88 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Response to Therapy at Day 15 (Physician Evaluation)	2.7 Score on a scale Standard Deviation 1.1	2.4 Score on a scale Standard Deviation 1.1	3.2 Score on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: Day 4

Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 4 data for Response to Therapy (participant evaluation).

Response to therapy was evaluated by participants and based upon their status scored at Day 4. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=103 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=104 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=103 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Response to Therapy at Day 4 (Participant Evaluation)	3.2 Score on a scale Standard Deviation 0.9	3.1 Score on a scale Standard Deviation 1.1	3.7 Score on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Day 15

Population: All randomized participants who completed at least one valid post-baseline visit and had available Day 15 data for Response to Therapy (participant evaluation).

Response to therapy was evaluated by participants and based upon their status scored at Day 15. Participants evaluated their response to therapy using the following 5-point scale: 1 = Complete Relief, 2 = Marked Relief, 3 = Moderate Relief, 4= Slight Relief, and 5 = Treatment Failure. The scores were averaged across each treatment group, with a lower score indicating a greater response to therapy and an improvement in nasal symptoms.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=95 Participants Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=95 Participants Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=88 Participants Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
Response to Therapy at Day 15 (Participant Evaluation)	2.6 Score on a scale Standard Deviation 1.1	2.4 Score on a scale Standard Deviation 1.1	3.4 Score on a scale Standard Deviation 1.3

Adverse Events

Mometasone Furoate Nasal Spray

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Fluticasone Propionate Nasal Spray

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Placebo Nasal Spray

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mometasone Furoate Nasal Spray n=104 participants at risk Participants received 200 mcg of mometasone furoate nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.	Fluticasone Propionate Nasal Spray n=104 participants at risk Participants received 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily for 14 days.	Placebo Nasal Spray n=103 participants at risk Participants receive mometasone furoate placebo matching nasal spray and fluticasone propionate placebo matching nasal spray once daily for 14 days.
General disorders FATIGUE	0.96% 1/104 • Number of events 1 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.	3.8% 4/104 • Number of events 5 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.	5.8% 6/103 • Number of events 13 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.
Nervous system disorders HEADACHE	13.5% 14/104 • Number of events 19 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.	12.5% 13/104 • Number of events 23 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.	17.5% 18/103 • Number of events 28 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.
Respiratory, thoracic and mediastinal disorders COUGH	6.7% 7/104 • Number of events 12 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.	6.7% 7/104 • Number of events 9 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.	3.9% 4/103 • Number of events 6 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.
Respiratory, thoracic and mediastinal disorders NASAL DISCOMFORT	6.7% 7/104 • Number of events 14 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.	5.8% 6/104 • Number of events 16 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.	3.9% 4/103 • Number of events 8 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	5.8% 6/104 • Number of events 9 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.	1.9% 2/104 • Number of events 3 • Up to 45 days All randomized participants who received at least one dose of study treatment and had at least one post-baseline evaluation for safety.	3.9% 4/103 • Number of events 7 • Up to 45 days All randomized 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 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