Trial Outcomes & Findings for The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3) (NCT NCT00423176)

Results Overview

The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the subject's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following subject-evaluated symptoms: facial pain/pressure/tenderness, sinus headache, purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion.MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

237 participants

Primary outcome timeframe

29-day Treatment Period and 2-week no-treatment Follow-up Period.

Results posted on

2024-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	Mometasone Furoate Nasal Spray (MFNS) Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).	Placebo Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
Overall Study STARTED	114	123
Overall Study COMPLETED	98	94
Overall Study NOT COMPLETED	16	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Mometasone Furoate Nasal Spray (MFNS) Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).	Placebo Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
Overall Study Adverse Event	4	6
Overall Study Treatment Failure	1	6
Overall Study Lost to Follow-up	4	7
Overall Study Withdrawal by Subject	4	3
Overall Study Protocol Violation	1	3
Overall Study Did not meet protocol eligibility	2	4

Baseline Characteristics

The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mometasone Furoate Nasal Spray (MFNS) n=114 Participants Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).	Placebo n=123 Participants Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).	Total n=237 Participants Total of all reporting groups
Age, Categorical <=18 years	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	106 Participants n=5 Participants	107 Participants n=7 Participants	213 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	39.3 years STANDARD_DEVIATION 13.2 • n=5 Participants	39.0 years STANDARD_DEVIATION 14.9 • n=7 Participants	39.2 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	80 Participants n=5 Participants	72 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	51 Participants n=7 Participants	85 Participants n=5 Participants

PRIMARY outcome

Timeframe: 29-day Treatment Period and 2-week no-treatment Follow-up Period.

Population: Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.

The least squares mean decrease from Baseline in AM/PM PRIOR MSS, excluding sinus headache, averaged over Days 1 to 29. PRIOR is the subject's status over the previous 12 hours (reflective). The MSS was defined as the sum of the following subject-evaluated symptoms: facial pain/pressure/tenderness, sinus headache, purulent rhinorrhea, post-nasal drip, and nasal stuffiness/congestion.MSS scores are as follows: 0=none, 1=mild, 2=moderate, 3=severe for each individual symptom.

Outcome measures

Outcome measures
Measure	Mometasone Furoate Nasal Spray (MFNS) n=99 Participants Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).	Placebo n=103 Participants Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29. Baseline	8.57 Units on a scale Standard Deviation 1.78	8.78 Units on a scale Standard Deviation 2.03
Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29. Days 1-29	-4.9 Units on a scale Standard Deviation 2.69	-4.46 Units on a scale Standard Deviation 2.54
Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29. Days 30-43 (follow-up)	-6.59 Units on a scale Standard Deviation 2.81	-5.77 Units on a scale Standard Deviation 2.98

PRIMARY outcome

Timeframe: 29-day Treatment Period and 2-week no-treatment Follow-up Period.

Population: Not every randomized subject had complete data therefore the number of participants analyzed and the number of participants in the participant flow do not match.

A coronal computerized tomography was obtained to visulaize all nasal sinuses and the ostiomeatal complex. Opacification was measured as a percentage of the area of the sinus that was occupied by either fluid or mucosal thickening. The change in percentage of opacification of one maxillary sinus (the one with the highest percentage of opacification) as compared to antibiotic treatment alone. The percentage of opacification was measured and the change from baseline for that percentage was reported.

Outcome measures

Outcome measures
Measure	Mometasone Furoate Nasal Spray (MFNS) n=99 Participants Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).	Placebo n=103 Participants Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline Baseline	50.7 Percentage of opacification Standard Deviation 30.4	56.8 Percentage of opacification Standard Deviation 31.7
Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline Change from Baseline at Endpoint	-23.7 Percentage of opacification Standard Deviation 35.2	-32.5 Percentage of opacification Standard Deviation 32.0

Adverse Events

Mometasone Furoate Nasal Spray (MFNS)

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Mometasone Furoate Nasal Spray (MFNS) n=114 participants at risk Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).	Placebo n=123 participants at risk Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
Musculoskeletal and connective tissue disorders Neck Pain	0.00% 0/114	0.81% 1/123 • Number of events 1

Other adverse events

Other adverse events
Measure	Mometasone Furoate Nasal Spray (MFNS) n=114 participants at risk Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).	Placebo n=123 participants at risk Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
Gastrointestinal disorders Diarrhoea	14.9% 17/114 • Number of events 19	11.4% 14/123 • Number of events 14
Infections and infestations Fungal Infection	5.3% 6/114 • Number of events 6	2.4% 3/123 • Number of events 4
Nervous system disorders Headache	5.3% 6/114 • Number of events 7	0.81% 1/123 • Number of events 1

Additional Information

Senior Vice Presdient, 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