Adenoids
Conditions
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).
Interventions
DRUGmometasone furoate nasal spray
One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
Sponsors
Organon and Co
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy | Baseline to 12 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 \[worst score\]). |
| 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 \[worst score\]). |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mometasone Furoate Nasal Spray One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months | 34 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 13 |
| Overall Study | Surgery (adenoidectomy) | 2 |
Baseline characteristics
| Characteristic | Mometasone Furoate Nasal Spray |
|---|---|
| Age, Customized | 4.84 Years |
| Region of Enrollment Lebanon | 34 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 34 |
| serious Total, serious adverse events | 0 / 34 |
Outcome results
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.
Time frame: Baseline and Week 12
Population: Only participants that completed the study are included.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Degree of Posterior Choana Obstruction at Baseline and Week 12 | Baseline score | 85 Percent obstruction |
| Mometasone Furoate Nasal Spray | Degree of Posterior Choana Obstruction at Baseline and Week 12 | Score at Week 12 | 61 Percent obstruction |
Primary
Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
Time frame: Baseline to 12 weeks
Population: Evaluable population (per protocol population, ie, those participants without protocol violation of inclusion or exclusion criteria)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mometasone Furoate Nasal Spray | Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy | 2 Participants |
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 \[worst score\]).
Time frame: Baseline and Week 12
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score | Baseline score | 3.89 Score on a scale |
| Mometasone Furoate Nasal Spray | Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical Score | Score at Week 12 | 1.26 Score on a scale |
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 \[worst score\]).
Time frame: Baseline and Week 12
Population: Participants suspected to have allergic rhinitis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Severity of Eye Symptoms at Baseline and Week 12 | Score at Week 12 | 0.16 Score on a scale |
| Mometasone Furoate Nasal Spray | Severity of Eye Symptoms at Baseline and Week 12 | Baseline score | 0.68 Score on a scale |
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 \[worst score\]).
Time frame: Baseline and Week 12
Population: Participants suspected to have allergic rhinitis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Severity of Nasal Congestion at Baseline and Week 12 | Baseline score | 0.79 Score on a scale |
| Mometasone Furoate Nasal Spray | Severity of Nasal Congestion at Baseline and Week 12 | Score at Week 12 | 0.32 Score on a scale |
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 \[worst score\]).
Time frame: Baseline and Week 12
Population: Participants suspected to have allergic rhinitis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Severity of Nasal Itching at Baseline and Week 12 | Baseline score | 0.74 Score on a scale |
| Mometasone Furoate Nasal Spray | Severity of Nasal Itching at Baseline and Week 12 | Score at Week 12 | 0.37 Score on a scale |
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 \[worst score\]).
Time frame: Baseline and Week 12
Population: Participants suspected to have allergic rhinitis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Severity of Rhinorrhea at Baseline and Week 12 | Baseline score | 0.95 Score on a scale |
| Mometasone Furoate Nasal Spray | Severity of Rhinorrhea at Baseline and Week 12 | Score at Week 12 | 0.37 Score on a scale |
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 \[worst score\]).
Time frame: Baseline and Week 12
Population: Participants suspected to have allergic rhinitis
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray | Severity of Sneezing at Baseline and Week 12 | Baseline score | 0.89 Score on a scale |
| Mometasone Furoate Nasal Spray | Severity of Sneezing at Baseline and Week 12 | Score at Week 12 | 0.37 Score on a scale |