Trial Outcomes & Findings for Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED) (NCT NCT00358527)

Results Overview

The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12. NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

401 participants

Primary outcome timeframe

Average of the last 7 days of treatment

Results posted on

2022-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	Mometasone Furoate Nasal Spray Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.	Placebo Nasal Spray. Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
Overall Study STARTED	267	134
Overall Study COMPLETED	254	131
Overall Study NOT COMPLETED	13	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Mometasone Furoate Nasal Spray Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.	Placebo Nasal Spray. Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
Overall Study Adverse Event	4	0
Overall Study Withdrawal by Subject	1	1
Overall Study Non-compliance with protocol	6	1
Overall Study Administrative	2	1

Baseline Characteristics

Mometasone Furoate on Sleep Disturbances in Subjects With Seasonal Allergic Rhinitis (Study P04608) (COMPLETED)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mometasone Furoate Nasal Spray n=267 Participants Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.	Placebo Nasal Spray. n=134 Participants Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.	Total n=401 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	259 Participants n=5 Participants	132 Participants n=7 Participants	391 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants
Age, Continuous	36.1 years STANDARD_DEVIATION 12.8 • n=5 Participants	35.1 years STANDARD_DEVIATION 11.8 • n=7 Participants	35.7 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	170 Participants n=5 Participants	85 Participants n=7 Participants	255 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	49 Participants n=7 Participants	146 Participants n=5 Participants

PRIMARY outcome

Timeframe: Average of the last 7 days of treatment

Population: Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.

The TNSS score included the sum of nasal congestion/stuffiness, rhinorrhea/nasal discharge, sneezing, and nasal itching, each scored on a scale of 0 = absent, 1 = mild, 2 = moderate, 3 = severe. The TNSS score could range from 0 to 12. NOTE: Least square means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.

Outcome measures

Outcome measures
Measure	Mometasone Furoate Nasal Spray n=248 Participants Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.	Placebo Nasal Spray. n=131 Participants Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. Change from Baseline in TNSS score	-3.77 Units on a scale Standard Error 0.19	-3.07 Units on a scale Standard Error 0.26
Mean Change of the AM-PRIOR-reflective (Participant's Status Over the Previous 12 Hours) Total Nasal Symptoms Severity Score (TNSS) Averaged Over the Last 7 Days of Treatment From the Baseline Score. Baseline TNSS score	9.10 Units on a scale Standard Error 0.10	9.12 Units on a scale Standard Error 0.14

PRIMARY outcome

Timeframe: 29 days

Population: Modified Intent-to-Treat (MITT) Population: all randomized subjects with any post-baseline data and without concomitant medications that could significantly bias the co-primary endpoints.

Following Visit 2 (Screening), at Baseline, Day 15, and Day 29 visits, participants needed to complete the MOS-SS questionnaire with scores from 1 = all of the time to 6 = none of the time, according to their frequency of occurrence during the previous week. The analysis endpoint MOS-SS Sleep Problems Index II (SLP9) score was derived from MOS-SS questionnaire and scaled from 0 = none of the time to 100 = all of the time. NOTE: Least squares means and standard errors were obtained from an ANCOVA model with the treatment effect and the variable specific Baseline as a covariate.

Outcome measures

Outcome measures
Measure	Mometasone Furoate Nasal Spray n=243 Participants Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.	Placebo Nasal Spray. n=126 Participants Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. Change from baseline in SLP9 score	-26.1 Units on a scale Standard Error 1.38	-25.8 Units on a scale Standard Error 1.90
Mean Change From Baseline (Day 1/Visit 3) in the Sleep Problems Index II (SLP9) Score From the Medical Outcome Study Sleep Scale (MOS-SS) at the Day 29 Visit. Baseline SLP9 Score	68.6 Units on a scale Standard Error 0.86	69.2 Units on a scale Standard Error 1.20

Adverse Events

Mometasone Furoate Nasal Spray

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo Nasal Spray.

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mometasone Furoate Nasal Spray n=267 participants at risk Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.	Placebo Nasal Spray. n=134 participants at risk Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
Immune system disorders Food allergy	0.37% 1/267 • Number of events 1	0.00% 0/134

Other adverse events

Other adverse events
Measure	Mometasone Furoate Nasal Spray n=267 participants at risk Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.	Placebo Nasal Spray. n=134 participants at risk Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
Nervous system disorders Headache	3.7% 10/267 • Number of events 16	5.2% 7/134 • Number of events 8

Additional Information

Senior Vice President, Global Clinical Development

Merck, Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI is not allowed to release any interim results of the Study without prior consent of the sponsor, and must provide 45 days written notice to the sponsor prior to public release to permit the sponsor's review. The PI can use the study results for his/her own teaching, research, and publication purposes only, not for commercial purposes, except as authorized by the sponsor. No publication shall contain any trade secret or proprietary/confidential information of the sponsor.
Publication restrictions are in place

Restriction type: OTHER