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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mometasone furoate nasal spray | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mometasone furoate nasal spray | Drug | One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23010795 | Result | 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. Epub 2012 Aug 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone Furoate Nasal Spray | One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone Furoate Nasal Spray | One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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]). | Posted | Mean | Full Range | Score on a scale | Baseline and Week 12 |
|
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In this study, symptoms of allergic rhinitis (rhinorrhea, nasal congestion, nasal itching, sneezing, and eye symptoms) were not reported as adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mometasone Furoate Nasal Spray | One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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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 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Only participants that completed the study are included. | Posted | Mean | Full Range | Percent obstruction | Baseline and Week 12 |
|
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| Primary | Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy | Evaluable population (per protocol population, ie, those participants without protocol violation of inclusion or exclusion criteria) | Posted | Number | Participants | 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]). | Participants suspected to have allergic rhinitis | Posted | Mean | Full Range | Score on a scale | Baseline and Week 12 |
|
|
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| 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]). | Participants suspected to have allergic rhinitis | Posted | Mean | Full Range | Score on a scale | 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]). | Participants suspected to have allergic rhinitis | Posted | Mean | Full Range | Score on a scale | Baseline and Week 12 |
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| 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]). | Participants suspected to have allergic rhinitis | Posted | Mean | Full Range | Score on a scale | Baseline and Week 12 |
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| 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]). | Participants suspected to have allergic rhinitis | Posted | Mean | Full Range | Score on a scale | Baseline and Week 12 |
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| 0 |
| 34 |
| 0 |
| 34 |
The principal investigator and his co-workers agree not to publish or publicly present any results of the study without the prior written consent and approval of the sponsor.
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |