Trial Outcomes & Findings for A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1) (NCT NCT01165424)

NCT ID: NCT01165424

Last Updated: 2024-05-24

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 80 participants
• Primary outcome timeframe: Baseline to Week 24
• Results posted on: 2024-05-24

Participant Flow

Participant milestones

Measure	MFNS Mometasone furoate nasal spray (MFNS) 50 mcg device. Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks. Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks.
Overall Study STARTED	80
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	MFNS Mometasone furoate nasal spray (MFNS) 50 mcg device. Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks. Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks.
Overall Study Clinical adverse experiences	1
Overall Study Laboratory adverse experiences	1
Overall Study Did not meet entry criteria	1
Overall Study Participant moved (relocated)	1

Baseline Characteristics

A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)

Baseline characteristics by cohort

Measure	MFNS n=80 Participants Mometasone furoate nasal spray (MFNS) 50 mcg device. Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks. Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks.
Age, Continuous	9.2 years STANDARD_DEVIATION 3.4 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	54 Participants n=5 Participants
Region of Enrollment Japan	80 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 24

Population: All treated participants

Outcome measures

Measure	MFNS n=80 Participants Mometasone furoate nasal spray (MFNS) 50 mcg device. Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks. Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks.
Number of Participants With Adverse Events and Adverse Drug Reactions Number with Adverse Events	76 participants
Number of Participants With Adverse Events and Adverse Drug Reactions Number with Adverse Drug Reactions	18 participants

SECONDARY outcome

Timeframe: Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation)

Population: All treated participants

Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.

Outcome measures

Measure	MFNS n=80 Participants Mometasone furoate nasal spray (MFNS) 50 mcg device. Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks. Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks.
Change From Baseline in the Total Nasal Symptom Score Change at Week 2	-3.1 units on a scale Standard Error 0.3
Change From Baseline in the Total Nasal Symptom Score Change at Week 4	-3.9 units on a scale Standard Error 0.3
Change From Baseline in the Total Nasal Symptom Score Change at Week 8	-4.4 units on a scale Standard Error 0.3
Change From Baseline in the Total Nasal Symptom Score Change at Week 12	-4.5 units on a scale Standard Error 0.3
Change From Baseline in the Total Nasal Symptom Score Change at Week 24	-4.8 units on a scale Standard Error 0.3

Adverse Events

MFNS

Serious events: 1 serious events

Other events: 72 other events

Deaths: 0 deaths

Serious adverse events

Measure	MFNS n=80 participants at risk Mometasone furoate nasal spray (MFNS) 50 mcg device. Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks. Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks.
Gastrointestinal disorders Inguinal hernia	1.2% 1/80 • Number of events 1

Other adverse events

Measure	MFNS n=80 participants at risk Mometasone furoate nasal spray (MFNS) 50 mcg device. Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks. Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks.
Gastrointestinal disorders Abdominal pain	7.5% 6/80 • Number of events 9
General disorders Pyrexia	16.2% 13/80 • Number of events 17
Infections and infestations Acute sinusitis	11.2% 9/80 • Number of events 15
Infections and infestations Acute tonsillitis	8.8% 7/80 • Number of events 8
Infections and infestations Bronchitis	12.5% 10/80 • Number of events 17
Infections and infestations Nasopharyngitis	51.2% 41/80 • Number of events 73
Infections and infestations Pharyngitis	13.8% 11/80 • Number of events 12
Infections and infestations Upper respiratory tract infection	6.2% 5/80 • Number of events 6
Investigations Blood cortisol decreased	33.8% 27/80 • Number of events 30
Respiratory, thoracic and mediastinal disorders Cough	10.0% 8/80 • Number of events 12
Respiratory, thoracic and mediastinal disorders Epistaxis	30.0% 24/80 • Number of events 69
Skin and subcutaneous tissue disorders Heat rash	7.5% 6/80 • Number of events 7

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

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, reveiw copies of abstracts or manuscripts for publication that report any results of the trial. The Sponsor shall have the right to reveiw and comment with respect to publications, abstracts, slides, and manuscripts and the right to reveiw and comment on the data analysis and presentation.
• Publication restrictions are in place

Restriction type: OTHER