Phase 4 N=34 Treatment

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

Adenoids

Bottom Line

View on ClinicalTrials.gov: NCT01098071 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2011

Primary outcome: Primary: Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score — 3.89; 1.26 Score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: mometasone furoate nasal spray (Drug)
Age: Pediatric · 2+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Sep 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score	3.89; 1.26	—
PRIMARY Degree of Posterior Choana Obstruction at Baseline and Week 12	85; 61	—
PRIMARY Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy	2	—
SECONDARY Severity of Rhinorrhea at Baseline and Week 12	0.95; 0.37	—
SECONDARY Severity of Nasal Congestion at Baseline and Week 12	0.79; 0.32	—
SECONDARY Severity of Nasal Itching at Baseline and Week 12	0.74; 0.37	—
SECONDARY Severity of Sneezing at Baseline and Week 12	0.89; 0.37	—
SECONDARY Severity of Eye Symptoms at Baseline and Week 12	0.68; 0.16	—

Summary

To document the short term & long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of the posterior choanae).

Eligibility Criteria

Inclusion Criteria

2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of posterior choanae.

Exclusion Criteria

adenoids hypertrophy < 50% of posterior choanae

recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic otitis media, cystic fibrosis, acute infection.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01098071). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.