A Phase 4 interventional study of mometasone furoate nasal spray in Adenoids, sponsored by Organon and Co. Completed. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2024-05-28.
Sponsored by Organon and Co · Phase 4, Interventional, and Treatment
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).
Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
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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.
Drug: mometasone furoate nasal spray
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Also known as: SCH 32088, Nasonex
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 \[worst score\]).
Time frame: 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.
Time frame: Baseline and Week 12
Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
Time frame: Baseline to 12 weeks
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 \[worst score\]).
Time frame: 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 \[worst score\]).
Time frame: 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 \[worst score\]).
Time frame: 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 \[worst score\]).
Time frame: 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 \[worst score\]).
Time frame: Baseline and Week 12
| Milestone | Mometasone Furoate Nasal Spray |
|---|---|
| Started | 34 |
| Completed | 19 |
| Not completed | 15 |
| Withdrew: Surgery (adenoidectomy) | 2 |
| Withdrew: Lost to follow-up | 13 |
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 \[worst score\]).
| Score on a scale | Mometasone Furoate Nasal Spray |
|---|---|
| Baseline score | 3.89 (2 to 5) |
| Score at Week 12 | 1.26 (0 to 4) |
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.
| Percent obstruction | Mometasone Furoate Nasal Spray |
|---|---|
| Baseline score | 85 (70 to 90) |
| Score at Week 12 | 61 (40 to 80) |
| Participants | Mometasone Furoate Nasal Spray |
|---|---|
| Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy | 2 |
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 \[worst score\]).
| Score on a scale | Mometasone Furoate Nasal Spray |
|---|---|
| Baseline score | 0.95 (0 to 3) |
| Score at Week 12 | 0.37 (0 to 2) |
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 \[worst score\]).
| Score on a scale | Mometasone Furoate Nasal Spray |
|---|---|
| Baseline score | 0.79 (0 to 3) |
| Score at Week 12 | 0.32 (0 to 3) |
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 \[worst score\]).
| Score on a scale | Mometasone Furoate Nasal Spray |
|---|---|
| Baseline score | 0.74 (0 to 3) |
| Score at Week 12 | 0.37 (0 to 1) |
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 \[worst score\]).
| Score on a scale | Mometasone Furoate Nasal Spray |
|---|---|
| Baseline score | 0.89 (0 to 3) |
| Score at Week 12 | 0.37 (0 to 2) |
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 \[worst score\]).
| Score on a scale | Mometasone Furoate Nasal Spray |
|---|---|
| Baseline score | 0.68 (0 to 3) |
| Score at Week 12 | 0.16 (0 to 1) |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | — | 0/34 (0%) | 0/34 (0%) |
| Age, Customized(Years) | Mometasone Furoate Nasal Spray |
|---|---|
| Mean | 4.84 (0.5 to 9.25) |
| Sex: Female, Male(Participants) | Mometasone Furoate Nasal Spray |
|---|---|
| Female | 15 |
| Male | 19 |
| Region of Enrollment(participants) | Mometasone Furoate Nasal Spray |
|---|---|
| Lebanon | 34 |
No study locations are listed for this record.
Plan to share: No
Ran from Aug 2008 to primary completion in Sep 2009, 13 months.
Results were first posted in Nov 2011, 2 years 2 months after primary completion.
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This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mometasone Furoate