Trial Outcomes & Findings for The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726) (NCT NCT00359216)

Results Overview

Apnea-Hypopnea Index (AHI), used to assess severity of sleep apnea based on total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. Determined by the frequency of occurrence of apnea-hypopnea episodes measured during sleep at home by an Embletta device.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

change from baseline (screening) at the end of 28 days of treatment

Results posted on

2024-05-23

Participant Flow

There was a screening period followed by a 7-day run-in period, followed by the treatment period.

Participant milestones

Participant milestones
Measure	Mometasone Furoate Nasal Spray 100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.	Placebo Nasal Spray The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
Overall Study STARTED	20	10
Overall Study COMPLETED	20	9
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mometasone Furoate Nasal Spray n=20 Participants 100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.	Placebo Nasal Spray n=10 Participants The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.	Total n=30 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	20 Participants n=5 Participants	10 Participants n=7 Participants	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.55 years STANDARD_DEVIATION 10.11 • n=5 Participants	33.70 years STANDARD_DEVIATION 8.11 • n=7 Participants	34.27 years STANDARD_DEVIATION 9.36 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	4 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: change from baseline (screening) at the end of 28 days of treatment

Population: Diary data over interval of days was derived using the mean of non-missing entries. No imputation was applied to any other missing data

Apnea-Hypopnea Index (AHI), used to assess severity of sleep apnea based on total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep. Determined by the frequency of occurrence of apnea-hypopnea episodes measured during sleep at home by an Embletta device.

Outcome measures

Outcome measures
Measure	Mometasone Furoate Nasal Spray n=20 Participants 100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.	Placebo Nasal Spray n=9 Participants The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
Apnea-Hypopnea Index	1.0 apnea-hypopnea episodes per hour Standard Deviation 2.1	1.6 apnea-hypopnea episodes per hour Standard Deviation 3.8

Adverse Events

Mometasone Furoate Nasal Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Nasal Spray

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Mometasone Furoate Nasal Spray n=20 participants at risk 100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.	Placebo Nasal Spray n=10 participants at risk The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
Gastrointestinal disorders Toothache	0.00% 0/20	10.0% 1/10 • Number of events 1

Additional Information

Senior Vice President, Global Clinical Development

Merck, Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60