Trial Outcomes & Findings for Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367) (NCT NCT01098071)

NCT ID: NCT01098071

Last Updated: 2024-05-28

Results Overview

Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms \[best score\] and 5 = worst symptoms \[worst score\]).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 34 participants
• Primary outcome timeframe: Baseline and Week 12
• Results posted on: 2024-05-28

Participant Flow

Participant milestones

Measure	Mometasone Furoate Nasal Spray One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Overall Study STARTED	34
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	15

Reasons for withdrawal

Measure	Mometasone Furoate Nasal Spray One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Overall Study Surgery (adenoidectomy)	2
Overall Study Lost to Follow-up	13

Baseline Characteristics

Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)

Baseline characteristics by cohort

Measure	Mometasone Furoate Nasal Spray n=34 Participants One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Age, Customized	4.84 Years n=93 Participants
Sex: Female, Male Female	15 Participants n=93 Participants
Sex: Female, Male Male	19 Participants n=93 Participants
Region of Enrollment Lebanon	34 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline and Week 12

Clinical score (based on a 5 point grading system) was assessed for each of 5 nasal obstruction symptoms (oral/mouth breathing, snoring, restless sleep, frequent waking-ups during the night, and obstructive breathing during sleep). Each nasal obstruction symptom was estimated by the parent/guardian of the participant and scored on a scale of 0 (best) to 1 (worst). Total clinical score is a score on a scale (0 = no symptoms [best score] and 5 = worst symptoms [worst score]).

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=19 Participants One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score Baseline score	3.89 Score on a scale Interval 2.0 to 5.0
Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score Score at Week 12	1.26 Score on a scale Interval 0.0 to 4.0

PRIMARY outcome

Timeframe: Baseline and Week 12

Population: Only participants that completed the study are included.

The degree of obstruction of the posterior choana was assessed by endoscopy. Endoscopy grading consisted of Grade I (minimum), Grade II and Grade III (maximum). Grade I was defined as <50% obstruction, Grade II was defined as 50-75% obstruction, and Grade III was defined as >75% obstruction.

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=19 Participants One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Degree of Posterior Choana Obstruction at Baseline and Week 12 Baseline score	85 Percent obstruction Interval 70.0 to 90.0
Degree of Posterior Choana Obstruction at Baseline and Week 12 Score at Week 12	61 Percent obstruction Interval 40.0 to 80.0

PRIMARY outcome

Timeframe: Baseline to 12 weeks

Population: Evaluable population (per protocol population, ie, those participants without protocol violation of inclusion or exclusion criteria)

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=19 Participants One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy	2 Participants

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Participants suspected to have allergic rhinitis

Rhinorrhea is a symptom of allergic rhinitis. Rhinorrhea was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=10 Participants One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Severity of Rhinorrhea at Baseline and Week 12 Baseline score	0.95 Score on a scale Interval 0.0 to 3.0
Severity of Rhinorrhea at Baseline and Week 12 Score at Week 12	0.37 Score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Participants suspected to have allergic rhinitis

Nasal congestion is a symptom of allergic rhinitis. Nasal congestion was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=10 Participants One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Severity of Nasal Congestion at Baseline and Week 12 Baseline score	0.79 Score on a scale Interval 0.0 to 3.0
Severity of Nasal Congestion at Baseline and Week 12 Score at Week 12	0.32 Score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Participants suspected to have allergic rhinitis

Nasal itching is a symptom of allergic rhinitis. Nasal itching was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=10 Participants One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Severity of Nasal Itching at Baseline and Week 12 Baseline score	0.74 Score on a scale Interval 0.0 to 3.0
Severity of Nasal Itching at Baseline and Week 12 Score at Week 12	0.37 Score on a scale Interval 0.0 to 1.0

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Participants suspected to have allergic rhinitis

Sneezing is a symptom of allergic rhinitis. Sneezing was assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=10 Participants One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Severity of Sneezing at Baseline and Week 12 Baseline score	0.89 Score on a scale Interval 0.0 to 3.0
Severity of Sneezing at Baseline and Week 12 Score at Week 12	0.37 Score on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: Baseline and Week 12

Population: Participants suspected to have allergic rhinitis

Eye symptoms are a symptom of allergic rhinitis. Eye symptoms were assessed using a 3-point scale (0 = no symptoms [best score] and 3 = symptom interferes with daily life activity [worst score]).

Outcome measures

Measure	Mometasone Furoate Nasal Spray n=10 Participants One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Severity of Eye Symptoms at Baseline and Week 12 Baseline score	0.68 Score on a scale Interval 0.0 to 3.0
Severity of Eye Symptoms at Baseline and Week 12 Score at Week 12	0.16 Score on a scale Interval 0.0 to 1.0

Adverse Events

Mometasone Furoate Nasal Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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 principal investigator and his co-workers agree not to publish or publicly present any results of the study without the prior written consent and approval of the sponsor.
• Publication restrictions are in place

Restriction type: OTHER