Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)
- Registration Number
- NCT01098071
- Lead Sponsor
- Organon and Co
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
- 2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of posterior choanae.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description mometasone furoate nasal spray mometasone furoate nasal spray -
- Primary Outcome Measures
Name Time Method Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy Baseline to 12 weeks Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score 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 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 Outcome Measures
Name Time Method Severity of Rhinorrhea at Baseline and Week 12 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 \[worst score\]).
Severity of Eye Symptoms at Baseline and Week 12 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 \[worst score\]).
Severity of Nasal Congestion at Baseline and Week 12 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 \[worst score\]).
Severity of Nasal Itching at Baseline and Week 12 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 \[worst score\]).
Severity of Sneezing at Baseline and Week 12 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 \[worst score\]).