Trial Outcomes & Findings for A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604) (NCT NCT01386125)

Last Updated: 2024-05-21

Results Overview

At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

748 participants

Primary outcome timeframe

Baseline and Weeks 1-4

Results posted on

2024-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Mometasone Furoate Nasal Spray (MFNS) Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks	Placebo Participants receive matching placebo nasal spray BID for 16 weeks
Overall Study STARTED	375	373
Overall Study COMPLETED	350	336
Overall Study NOT COMPLETED	25	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Mometasone Furoate Nasal Spray (MFNS) Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks	Placebo Participants receive matching placebo nasal spray BID for 16 weeks
Overall Study Lost to Follow-up	3	9
Overall Study Physician Decision	0	1
Overall Study Protocol Violation	5	7
Overall Study Disease Progress	1	2
Overall Study Withdrawal by Subject	13	12
Overall Study Adverse Event	2	5
Overall Study Lack of Efficacy	0	1
Overall Study Participant Leaving Country	1	0

Baseline Characteristics

A Study of the Effectiveness and Safety of Mometasone Furoate Nasal Spray (MFNS, SCH 032088) for the Treatment of Nasal Polyps (P05604)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MFNS n=375 Participants Participants receive MFNS 200 mcg BID for 16 weeks	Placebo n=373 Participants Participants receive matching placebo nasal spray BID for 16 weeks	Total n=748 Participants Total of all reporting groups
Age, Continuous	46.8 years STANDARD_DEVIATION 13.49 • n=5 Participants	46.8 years STANDARD_DEVIATION 13.75 • n=7 Participants	46.8 years STANDARD_DEVIATION 13.61 • n=5 Participants
Sex: Female, Male Female	151 Participants n=5 Participants	134 Participants n=7 Participants	285 Participants n=5 Participants
Sex: Female, Male Male	224 Participants n=5 Participants	239 Participants n=7 Participants	463 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Weeks 1-4

Population: The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment.

Outcome measures

Outcome measures
Measure	MFNS n=372 Participants Participants receive MFNS 200 mcg BID for 16 weeks	Placebo n=371 Participants Participants receive matching placebo nasal spray BID for 16 weeks
Change From Baseline in Congestion/Obstruction Score	-0.56 score on a scale Standard Error 0.03	-0.42 score on a scale Standard Error 0.03

PRIMARY outcome

Timeframe: Baseline and Week 16

Population: The FAS population consisted of all randomized participants who received at least one dose of study treatment and who had a baseline and at least one post-baseline efficacy assessment.

An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline.

Outcome measures

Outcome measures
Measure	MFNS n=375 Participants Participants receive MFNS 200 mcg BID for 16 weeks	Placebo n=373 Participants Participants receive matching placebo nasal spray BID for 16 weeks
Change From Baseline in Total Polyp Size Score	-0.76 score on a scale Standard Error 0.05	-0.45 score on a scale Standard Error 0.05

Adverse Events

MFNS

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	MFNS n=375 participants at risk Participants receive MFNS 200 mcg BID for 16 weeks	Placebo n=373 participants at risk Participants receive matching placebo nasal spray BID for 16 weeks
Cardiac disorders Ventricular extrasystoles	0.00% 0/375 • Up to approximately 20 weeks	0.27% 1/373 • Number of events 1 • Up to approximately 20 weeks
Injury, poisoning and procedural complications Fracture	0.00% 0/375 • Up to approximately 20 weeks	0.27% 1/373 • Number of events 1 • Up to approximately 20 weeks
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/375 • Up to approximately 20 weeks	0.27% 1/373 • Number of events 1 • Up to approximately 20 weeks
Respiratory, thoracic and mediastinal disorders Asthma	0.27% 1/375 • Number of events 1 • Up to approximately 20 weeks	0.00% 0/373 • Up to approximately 20 weeks
Surgical and medical procedures Nasal polypectomy	0.27% 1/375 • Number of events 1 • Up to approximately 20 weeks	0.00% 0/373 • Up to approximately 20 weeks

Other adverse events

Adverse event data not reported

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 Investigator agrees to provide to the sponsor 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
Publication restrictions are in place

Restriction type: OTHER