Adenoids Clinical Trial
— NAHChOfficial title:
Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
| Verified date | February 2022 |
| Source | Organon and Co |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 34 |
| Est. completion date | September 1, 2009 |
| Est. primary completion date | September 1, 2009 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 11 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Organon and Co |
Bitar MA, Mahfoud L, Nassar J, Dana R. Exploring the characteristics of children with obstructive adenoid responding to mometasone fuorate monohydrate: preliminary results. Eur Arch Otorhinolaryngol. 2013 Mar;270(3):931-7. doi: 10.1007/s00405-012-2155-8. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy | Baseline to 12 weeks | ||
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |