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

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).

Official Title
-----------------
Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children

Conditions
-----------------
Adenoids

Intervention / Treatment
-----------------
* Drug: mometasone furoate nasal spray


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mometasone furoate nasal spray<br> | Drug: mometasone furoate nasal spray<br>* One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months<br>* Other names: Nasonex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score | 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]). | Baseline and Week 12 | 
| Degree of Posterior Choana Obstruction at 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. | Baseline and Week 12 | 
| Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy |  | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of Rhinorrhea at Baseline and Week 12 | 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]). | Baseline and Week 12 | 
| Severity of Nasal Congestion at Baseline and Week 12 | 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]). | Baseline and Week 12 | 
| Severity of Nasal Itching at Baseline and Week 12 | 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]). | Baseline and Week 12 | 
| Severity of Sneezing at Baseline and Week 12 | 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]). | Baseline and Week 12 | 
| Severity of Eye Symptoms at Baseline and Week 12 | 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]). | Baseline and Week 12 |