Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 34
- Primary Endpoint
- Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
Study Overview
Brief 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
mometasone furoate nasal spray
Intervention: mometasone furoate nasal spray (Drug)
Outcomes
Primary Outcomes
Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
Time Frame: Baseline to 12 weeks
Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score
Time Frame: 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 \[worst score\]).
Degree of Posterior Choana Obstruction at Baseline and Week 12
Time Frame: Baseline and Week 12
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.
Secondary Outcomes
- Severity of Rhinorrhea at Baseline and Week 12(Baseline and Week 12)
- Severity of Eye Symptoms at Baseline and Week 12(Baseline and Week 12)
- Severity of Nasal Congestion at Baseline and Week 12(Baseline and Week 12)
- Severity of Nasal Itching at Baseline and Week 12(Baseline and Week 12)
- Severity of Sneezing at Baseline and Week 12(Baseline and Week 12)