Trial Outcomes & Findings for Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155) (NCT NCT00552032)
NCT ID: NCT00552032
Last Updated: 2024-05-20
Results Overview
Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size.
COMPLETED
PHASE3
132 participants
Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)
2024-05-20
Participant Flow
135 participants were screened, a total of 132 participants were randomized to receive either Mometasone furoate nasal spray (MFNS) (n=66) or placebo nasal spray (n=66).
Participant milestones
| Measure |
Mometasone Furoate Nasal Spray
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
|
Overall Study
COMPLETED
|
49
|
47
|
|
Overall Study
NOT COMPLETED
|
17
|
19
|
Reasons for withdrawal
| Measure |
Mometasone Furoate Nasal Spray
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Protocol Violation
|
7
|
12
|
|
Overall Study
Lost to Follow-up
|
8
|
5
|
Baseline Characteristics
Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155)
Baseline characteristics by cohort
| Measure |
Mometasone Furoate Nasal Spray
n=66 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
5.56 years
STANDARD_DEVIATION 2.27 • n=5 Participants
|
5.36 years
STANDARD_DEVIATION 2.50 • n=7 Participants
|
5.46 years
STANDARD_DEVIATION 2.38 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)Population: A total of 132 participants were included in the intent-to-treat (ITT) population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data are summarized in terms of the number of participants providing data at the relevant time point.
Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=66 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Change From Baseline in Adenoid/Choana (A/C) Index Grade
Change at Visit 3 (n=65 MFNS, n=63 Placebo)
|
0.3 Score on a Scale
Standard Deviation 0.6
|
0.2 Score on a Scale
Standard Deviation 0.5
|
|
Change From Baseline in Adenoid/Choana (A/C) Index Grade
Change at Visit 4 (n=61 MFNS, n=58 Placebo)
|
0.4 Score on a Scale
Standard Deviation 0.7
|
0.3 Score on a Scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.
Symptoms were assessed by whole-number linear scale to grade their severity. Scores were recorded AM \& PM (a difference of 12 hours) \& were based on severity within 12 hours of prior recording. The following symptoms were evaluated: Snoring; Nasal obstruction \& discharge; Breathing difficulty; Oral respiration; Ear pain. Severity was graded according to the following scale: 0=absent; 1=mild; 2=moderate; 3=severe. Severity was scored individually and summed to obtain the Total Symptom Severity Score. The maximum total score possible was 36 daily; 18 for both AM (6 symptoms times max severity of 3)and PM.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=66 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Total Severity Symptom Scores: Morning and Evening (AM & PM)
Visit 2 AM (n=66 MFNS, n=66 Placebo)
|
9.4 Score on a scale
Standard Deviation 2.5
|
9.9 Score on a scale
Standard Deviation 3.3
|
|
Total Severity Symptom Scores: Morning and Evening (AM & PM)
Visit 3 AM (n=64 MFNS, n=65 Placebo)
|
5.4 Score on a scale
Standard Deviation 3.8
|
6.4 Score on a scale
Standard Deviation 3.7
|
|
Total Severity Symptom Scores: Morning and Evening (AM & PM)
Visit 4 AM (n=62 MFNS, n=60 Placebo)
|
4.2 Score on a scale
Standard Deviation 3.6
|
5.5 Score on a scale
Standard Deviation 3.5
|
|
Total Severity Symptom Scores: Morning and Evening (AM & PM)
Visit 2 PM (n=66 MFNS, n=66 Placebo)
|
9.9 Score on a scale
Standard Deviation 3.2
|
10.2 Score on a scale
Standard Deviation 2.8
|
|
Total Severity Symptom Scores: Morning and Evening (AM & PM)
Visit 3 PM (n=64 MFNS, n=65 Placebo)
|
6.3 Score on a scale
Standard Deviation 3.7
|
7.0 Score on a scale
Standard Deviation 3.6
|
|
Total Severity Symptom Scores: Morning and Evening (AM & PM)
Visit 4 PM (n=62 MFNS, n=60 Placebo)
|
4.8 Score on a scale
Standard Deviation 3.8
|
5.7 Score on a scale
Standard Deviation 3.8
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.
Symptoms were assessed by whole-number linear scale to grade their frequency. Scores were recorded AM \& PM (a difference of 12 hours) \& were based on frequency within 12 hours of prior recording. The following signs/symptoms were evaluated: Snoring; Nasal obstruction; and nasal discharge; Breathing difficulty; Oral respiration; Ear pain. Frequency was graded according to the following scale: 0=absent; 1=intermittent; 2=persistent. The frequency of symptoms was scored individually and summed to obtain the Total Frequency Symptom Score. The maximum total score possible was 24 daily; 12 for both AM (6 symptoms times max frequency of 2) and PM.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=66 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Total Frequency Symptom Scores: AM & PM
Visit 2 AM (n=66 MFNS, n=66 Placebo)
|
7.3 Score on a scale
Standard Deviation 1.9
|
7.3 Score on a scale
Standard Deviation 2.4
|
|
Total Frequency Symptom Scores: AM & PM
Visit 3 AM (n=64 MFNS, n=65 Placebo)
|
4.4 Score on a scale
Standard Deviation 2.7
|
5.4 Score on a scale
Standard Deviation 2.6
|
|
Total Frequency Symptom Scores: AM & PM
Visit 4 AM (n=62 MFNS, n=60 Placebo)
|
3.7 Score on a scale
Standard Deviation 2.8
|
4.4 Score on a scale
Standard Deviation 2.5
|
|
Total Frequency Symptom Scores: AM & PM
Visit 2 PM (n=66 MFNS, n=66 Placebo)
|
7.6 Score on a scale
Standard Deviation 2.2
|
8.0 Score on a scale
Standard Deviation 2.1
|
|
Total Frequency Symptom Scores: AM & PM
Visit 3 PM (n=64 MFNS, n=65 Placebo)
|
5.3 Score on a scale
Standard Deviation 2.8
|
5.7 Score on a scale
Standard Deviation 2.6
|
|
Total Frequency Symptom Scores: AM & PM
Visit 4 PM (n=62 MFNS, n=60 Placebo)
|
4.1 Score on a scale
Standard Deviation 2.9
|
4.6 Score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.
Tympanometry was performed in children ages 2-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (normal pressure in the middle ear with normal mobility of the eardrum and the conduction bones) , abnormal (abnormal pressure in the middle ear and/or abnormal mobility of the eardrum and the conduction bones), or tympanometry was not done (evaluation not completed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=66 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
Visit 2- Normal (n=66 MFNS, n=66 Placebo)
|
35 Participants
|
39 Participants
|
|
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
Visit 2- Abnormal (n=66 MFNS, n=66 Placebo)
|
25 Participants
|
22 Participants
|
|
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
Visit 2- Not Done (n=66 MFNS, n=66 Placebo)
|
6 Participants
|
5 Participants
|
|
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
Visit 3- Normal (n=65 MFNS, n=65 Placebo)
|
44 Participants
|
33 Participants
|
|
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
Visit 3- Abnormal (n=65 MFNS, n=65 Placebo)
|
14 Participants
|
22 Participants
|
|
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
Visit 3- Not Done (n=65 MFNS, n=65 Placebo)
|
7 Participants
|
10 Participants
|
|
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
Visit 4- Normal (n=62 MFNS, n=60 Placebo)
|
45 Participants
|
39 Participants
|
|
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
Visit 4- Abnormal (n=62 MFNS, n=60 Placebo)
|
16 Participants
|
19 Participants
|
|
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
Visit 4- Not Done (n=62 MFNS, n=60 Placebo)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.
Otoscopic examination was performed of the right and left ear canals at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on audiologist's assessment as either being normal (ear canal structures appear normal) or abnormal (ear canal structures appear abnormal).
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=66 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Left Otoscopy Visit 3- Normal (n=65, n=65)
|
51 Participants
|
55 Participants
|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Right Otoscopy: Visit 2- Abnormal (n=66, n=66)
|
16 Participants
|
15 Participants
|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Right Otoscopy Visit 3- Normal (n=65, n=65)
|
54 Participants
|
53 Participants
|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Right Otoscopy Visit 3- Abnormal (n=65, n=65)
|
11 Participants
|
12 Participants
|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Right Otoscopy Visit 4- Normal (n=62, n=60)
|
49 Participants
|
52 Participants
|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Right Otoscopy Visit 4- Abnormal (n=62, n=60)
|
13 Participants
|
8 Participants
|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Left Otoscopy Visit 3- Abnormal (n=65, n=65)
|
14 Participants
|
10 Participants
|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Left Otoscopy Visit 4- Normal (n=62, n=60)
|
48 Participants
|
52 Participants
|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Left Otoscopy Visit 4- Abnormal (n=62, n=60)
|
14 Participants
|
8 Participants
|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Right Otoscopy: Visit 2- Normal (n=66, n=66)
|
50 Participants
|
51 Participants
|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Left Otoscopy: Visit 2- Normal (n=66, n=66)
|
49 Participants
|
52 Participants
|
|
Number of Participants With Otoscopic Results of: Normal or Abnormal
Left Otoscopy: Visit 2- Abnormal (n=66, n=66)
|
17 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.
Rhinoscopic examination of the septum was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being aligned (septum is aligned), non-obstructive (septum is not aligned but the deviation is non-obstructive), or obstructive (septum is deviated and obstructive) deviation.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=66 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
Visit 2 Aligned (n= 66, n=66)
|
65 Participants
|
63 Participants
|
|
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
Visit 2 Non-obstructive Deviation (n= 66, n=66)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
Vist 2 Obstructive Deviation (n=66, n=66)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
Visit 3 Aligned (n=65, n=65)
|
64 Participants
|
62 Participants
|
|
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
Visit 4 Non-obstructive Deviation (n=62, n=60)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
Visit 4 -Obstructive Deviation (n=62, n=60)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
Visit 3 Non-obstructive Deviation (n=65, n=65)
|
1 Participants
|
3 Participants
|
|
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
Visit 3 Obstructive Deviation (n=65, n=65)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
Visit 4 Aligned (n=62, n=60)
|
61 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.
Rhinoscopic examination of the inferior turbinates was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment as either being normal appearance (normal size) , hypertrophic (swollen/normal size increased), or hypotrophic (normal size diminished).
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=66 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
Visit 2- Normal Appearance (n=66, n=66)
|
50 Participants
|
46 Participants
|
|
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
Vist 2 Hypotrophic (n=66, n=66)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
Visit 3 Normal Appearance (n=65, n=65)
|
46 Participants
|
48 Participants
|
|
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
Visit 3 Hypertrophic (n=65, n=65)
|
19 Participants
|
17 Participants
|
|
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
Visit 4 Hypotrophic (n=62, n=60)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
Visit 2 Hypertrophic (n=66, n=66)
|
16 Participants
|
20 Participants
|
|
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
Visit 3 Hypotrophic (n=65, n=65)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
Visit 4 Normal Appearance (n=62, n=60)
|
45 Participants
|
42 Participants
|
|
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
Visit 4 Hypertrophic (n=62, n=60)
|
17 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.
Rhinoscopic examination of the middle meatus was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4). Results were categorized based on investigator's assessment into 3 categories: patent (easily observed), partial obstruction (partially blocked from view), or total obstruction (completely blocked from view).
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=66 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
Visit 3- Partial Obstruction (n=65, n=65)
|
4 Participants
|
2 Participants
|
|
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
Visit 4- Patent (n=62, n=60)
|
56 Participants
|
53 Participants
|
|
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
Visit 2- Patent (n=66, n=66)
|
62 Participants
|
60 Participants
|
|
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
Visit 2- Partial Obstruction (n=66, n=66)
|
3 Participants
|
5 Participants
|
|
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
Visit 2- Total Obstruction (n=66, n=66)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
Visit 3- Patent (n=65, n=65)
|
61 Participants
|
61 Participants
|
|
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
Visit 3- Total Obstruction (n=65, n=65)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
Visit 4- Partial Obstruction (n= 62, n=60)
|
6 Participants
|
4 Participants
|
|
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
Visit 4- Total Obstruction (n=62, n=60)
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: This analysis was only performed in a cohort of the ITT in participants aged 7-11 years old (MFSN=19, Placebo=20).
Rhinomanometry examination of the left \& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years. Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate inspiratory nasal airway resistance reported in Pascal/centimeter\^3/second (Pa/cm\^3/sec).
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=19 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=20 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance
Visit 2- Left Nasal Fossa (n=19, n=20)
|
2.111 Pa/cm^3/sec
Standard Deviation 4.372
|
3.280 Pa/cm^3/sec
Standard Deviation 7.852
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance
Visit 4- Left Nasal Fossa (n=19, n=19)
|
31.074 Pa/cm^3/sec
Standard Deviation 131.718
|
54.724 Pa/cm^3/sec
Standard Deviation 229.437
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance
Visit 4- Right Nasal Fossa (n=19, n=19)
|
2.560 Pa/cm^3/sec
Standard Deviation 6.918
|
43.621 Pa/cm^3/sec
Standard Deviation 174.535
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance
Visit 3- Left Nasal Fossa (n=18, n=18)
|
6.341 Pa/cm^3/sec
Standard Deviation 22.759
|
1.934 Pa/cm^3/sec
Standard Deviation 2.234
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance
Visit 2- Right Nasal Fossa (n=19, n=20)
|
2.985 Pa/cm^3/sec
Standard Deviation 8.527
|
6.535 Pa/cm^3/sec
Standard Deviation 24.836
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance
Visit 3- Right Nasal Fossa (n=18, n=18)
|
1.823 Pa/cm^3/sec
Standard Deviation 4.454
|
3.026 Pa/cm^3/sec
Standard Deviation 8.258
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).
Rhinomanometry examination of the left \& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years. Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. These findings were used to calculate expiratory nasal airway resistance reported in Pascal/centimeter\^3/second (Pa/cm\^3/sec).
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=19 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=20 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance
Visit 2- Left Nasal Fossa (n=19, n=20)
|
1.771 Pa/cm^3/sec
Standard Deviation 2.764
|
3.994 Pa/cm^3/sec
Standard Deviation 9.416
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance
Visit 3- Left Nasal Fossa (n=18, n=18)
|
2.937 Pa/cm^3/sec
Standard Deviation 8.196
|
1.478 Pa/cm^3/sec
Standard Deviation 1.647
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance
Visit 4- Left Nasal Fossa (n=19, n=19)
|
13.488 Pa/cm^3/sec
Standard Deviation 32.344
|
4.148 Pa/cm^3/sec
Standard Deviation 13.999
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance
Visit 2- Right Nasal Fossa (n=19, n=20)
|
2.625 Pa/cm^3/sec
Standard Deviation 6.868
|
1.083 Pa/cm^3/sec
Standard Deviation 1.109
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance
Visit 3- Right Nasal Fossa (n=18, n=18)
|
2.189 Pa/cm^3/sec
Standard Deviation 4.678
|
3.646 Pa/cm^3/sec
Standard Deviation 8.313
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance
Visit 4- Right Nasal Fossa (n=19, n=19)
|
0.961 Pa/cm^3/sec
Standard Deviation 0.758
|
2.792 Pa/cm^3/sec
Standard Deviation 6.318
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).
Rhinomanometry examination of the left \& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years. Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Inspiration flow was calculated at 75 Pa.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=19 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=20 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa
Visit 2- Left Nasal Fossa (n=19, n=20)
|
200.530 cm^3/sec
Standard Deviation 140.492
|
178.933 cm^3/sec
Standard Deviation 129.272
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa
Visit 3- Left Nasal Fossa (n=18, n=18)
|
222.152 cm^3/sec
Standard Deviation 141.740
|
151.268 cm^3/sec
Standard Deviation 130.115
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa
Visit 4- Left Nasal Fossa (n=19, n=19)
|
194.208 cm^3/sec
Standard Deviation 100.746
|
172.346 cm^3/sec
Standard Deviation 102.607
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa
Visit 2- Right Nasal Fossa (n=19, n=20)
|
183.562 cm^3/sec
Standard Deviation 121.780
|
161.958 cm^3/sec
Standard Deviation 138.673
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa
Visit 3- Right Nasal Fossa (n=18, n=18)
|
228.661 cm^3/sec
Standard Deviation 149.318
|
197.266 cm^3/sec
Standard Deviation 123.763
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa
Visit 4- Right Nasal Fossa (n=19, n=19)
|
215.400 cm^3/sec
Standard Deviation 157.794
|
183.368 cm^3/sec
Standard Deviation 117.677
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).
Rhinomanometry examination of the left \& right Nasal Fossa was performed at baseline (visit 2) and each visit throughout treatment (visit 3 and visit 4) in participants ages 7-11 years. Rhinomanometry is a test of nasal function that measures air pressure and the rate of airflow in the nasal airway during respiration by means of equipment. Expiratory flow was calculated at 75 Pa.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=19 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=20 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa
Visit 4- Right Nasal Fossa (n=19, n=19)
|
195.108 cm^3/sec
Standard Deviation 163.411
|
176.587 cm^3/sec
Standard Deviation 111.421
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa
Visit 2- Left Nasal Fossa (n=19, n=20)
|
190.024 cm^3/sec
Standard Deviation 146.067
|
166.930 cm^3/sec
Standard Deviation 116.802
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa
Visit 3- Left Nasal Fossa (n=18, n=18)
|
225.911 cm^3/sec
Standard Deviation 154.830
|
173.139 cm^3/sec
Standard Deviation 151.783
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa
Visit 4- Left Nasal Fossa (n=19, n=19)
|
181.026 cm^3/sec
Standard Deviation 119.728
|
192.374 cm^3/sec
Standard Deviation 134.337
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa
Visit 2- Right Nasal Fossa (n=19, n=20)
|
160.531 cm^3/sec
Standard Deviation 117.988
|
166.302 cm^3/sec
Standard Deviation 132.754
|
|
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa
Visit 3- Right Nasal Fossa (n=18, n=18)
|
209.676 cm^3/sec
Standard Deviation 157.215
|
209.787 cm^3/sec
Standard Deviation 151.298
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).
Pure-tone audiometry was performed in children ages 7-11 by certified audiologists. Results were categorized based on audiologist's assessment as either being normal (within normal limits), abnormal (outside normal limits), or audiometry was not done (not performed). Results were assessed at baseline, Week 4 (Visit 3), and endpoint Week 8 (end of treatment).
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=19 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=20 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
Visit 2- Normal (n=19 MFNS, n=21 Placebo)
|
13 Participants
|
18 Participants
|
|
Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
Visit 4- Normal (n=19 MFNS, n=20 Placebo)
|
15 Participants
|
18 Participants
|
|
Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
Visit 4- Abnormal (n=19 MFNS, n=20 Placebo)
|
2 Participants
|
2 Participants
|
|
Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
Visit 2- Abnormal (n=19 MFNS, n=21 Placebo)
|
5 Participants
|
2 Participants
|
|
Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
Visit 2- Not Done (n=19 MFNS, n= 21 Placebo)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
Visit 3- Normal (n=20 MFNS, n=21 Placebo)
|
15 Participants
|
20 Participants
|
|
Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
Visit 3- Abnormal (n=20 MFNS, n=21 Placebo)
|
4 Participants
|
1 Participants
|
|
Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
Visit 3- Not Done (n=20 MFNS, n=21 Placebo)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
Visit 4- Not Done (n=19 MFNS, n=20 Placebo)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).
Acoustic rhinometry examination of the left \& right Nasal Fossa was performed by principal investigators at baseline \& each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities. Measurements were taken for each side of the nose (nasopharyngeal minimum cross-sectional area) \& were reported in cm\^3.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=19 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=20 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa
Visit 2- Left Nasal Fossa (n=19, n=20)
|
0.599 cm^3
Standard Deviation 0.567
|
0.491 cm^3
Standard Deviation 0.265
|
|
Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa
Visit 3- Left Nasal Fossa (n=18, n=18)
|
0.608 cm^3
Standard Deviation 0.485
|
0.594 cm^3
Standard Deviation 0.403
|
|
Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa
Visit 4- Left Nasal Fossa (n=19, n=19)
|
0.662 cm^3
Standard Deviation 0.444
|
0.661 cm^3
Standard Deviation 0.444
|
|
Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa
Visit 2- Right Nasal Fossa (n=19, n=20)
|
0.532 cm^3
Standard Deviation 0.467
|
0.577 cm^3
Standard Deviation 0.381
|
|
Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa
Visit 3- Right Nasal Fossa (n=18, n=18)
|
0.581 cm^3
Standard Deviation 0.405
|
0.596 cm^3
Standard Deviation 0.383
|
|
Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa
Visit 4- Right Nasal Fossa (n=19, n=19)
|
0.734 cm^3
Standard Deviation 0.599
|
0.814 cm^3
Standard Deviation 0.675
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: This analysis was only performed in a cohort of the ITT in participants ages 7-11 years old (MFSN=19, Placebo=20).
Acoustic rhinometry examination of the left \& right Nasal Fossa was performed by principal investigators at baseline \& each visit throughout treatment in participants ages 7-11 years. Acoustic rhinometry is a technique intended for assessment of the geometry of the nasal cavity and nasopharynx and for evaluating nasal obstruction. The technique is based on an analysis of sound waves reflected from the nasal cavities.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=19 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=20 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa
Visit 4- Right Nasal Fossa (n=19, n=19)
|
3.774 cm^3
Standard Deviation 1.240
|
3.275 cm^3
Standard Deviation 1.083
|
|
Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa
Visit 2- Left Nasal Fossa (n=19, n=20)
|
4.245 cm^3
Standard Deviation 1.954
|
4.117 cm^3
Standard Deviation 3.554
|
|
Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa
Visit 3- Left Nasal Fossa (n=18, n=18)
|
3.725 cm^3
Standard Deviation 1.944
|
3.489 cm^3
Standard Deviation 1.589
|
|
Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa
Visit 4- Left Nasal Fossa (n=19, n=19)
|
3.631 cm^3
Standard Deviation 0.905
|
3.084 cm^3
Standard Deviation 1.724
|
|
Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa
Visit 2- Right Nasal Fossa (n=19, n=20)
|
3.566 cm^3
Standard Deviation 1.629
|
4.489 cm^3
Standard Deviation 2.941
|
|
Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa
Visit 3- Right Nasal Fossa (n=19, n=18)
|
4.183 cm^3
Standard Deviation 1.341
|
4.884 cm^3
Standard Deviation 3.591
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: A total of 132 participants were included in the ITT population. The ITT population included all randomized participants who received at least one dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point.
PSQ consists of 90 variables divided into 3 different factors:snoring, somnolence, and behavior. All positive Snoring and Somnolence answers scored with Yes=1 and No=0, and scores averaged to obtain a total score between 0.00 and 1.00. Behavior factor scored between 1-3, and scores averaged for total score of 1 to 3. Increased scores indicate increasing abnormality of sleep. Based on determined cut-offs, participants were categorized as having mild, moderate, or severe discomfort due to interference of sleep.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=66 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=65 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
Visit 2- Moderate (n=66 MFNS, n=65 Placebo)
|
17 Participants
|
26 Participants
|
|
Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
Visit 2- Severe (n=66 MFNS, n=65 Placebo)
|
16 Participants
|
9 Participants
|
|
Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
Visit 3- Mild (n=65 MFNS, n=65 Placebo)
|
50 Participants
|
45 Participants
|
|
Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
Visit 3- Moderate (n=65 MFNS, n=Placebo)
|
11 Participants
|
17 Participants
|
|
Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
Visit 3- Severe (n=65 MFNS, n=65 Placebo)
|
4 Participants
|
3 Participants
|
|
Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
Visit 4- Mild (n=62 MFNS, n=59 Placebo)
|
49 Participants
|
47 Participants
|
|
Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
Visit 4- Moderate (n=62 MFNS, n=59 Placebo)
|
13 Participants
|
10 Participants
|
|
Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
Visit 2- Mild (n=66 MFNS, n=65 Placebo)
|
33 Participants
|
30 Participants
|
|
Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
Visit 4- Severe (n=62 MFNS, n= 59 Placebo)
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: The ITT population included all randomized participants who received \>= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 2 and 4 years old, 23 participants in MFNS \& 29 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.
The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered \& answered by participants' parents. This modular instrument consists of 21 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \& school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=23 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=29 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)
Visit 2 (n= 23 MFNS, n=29 Placebo)
|
78.442 Score on a scale
Standard Deviation 13.114
|
78.017 Score on a scale
Standard Deviation 14.769
|
|
Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)
Visit 3 (n=22 MFNS, n= 28 Placebo)
|
80.438 Score on a scale
Standard Deviation 15.827
|
78.486 Score on a scale
Standard Deviation 15.707
|
|
Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)
Visit 4 (n=18 MFNS, n=25 Placebo)
|
80.137 Score on a scale
Standard Deviation 15.161
|
82.701 Score on a scale
Standard Deviation 11.911
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: The ITT population included all randomized participants who received \>= 1 dose after commencement of treatment. At baseline (visit 2), 52 randomized participants were between 5 and 7 years old, 28 participants in MFNS \& 24 subjects in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.
The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered \& answered by participants' parents. Questionnaire consists of 23 items using a 3-point scale: from 0 (not at all), 2 (sometimes), 4 (a lot). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \& school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=28 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=24 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)
Visit 4 (n=28 MFNS, n=22 Placebo)
|
83.54 Score on a scale
Standard Deviation 13.63
|
82.71 Score on a scale
Standard Deviation 13.52
|
|
Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)
Visit 2 (n= 28 MFNS, n=24 Placebo)
|
78.14 Score on a scale
Standard Deviation 15.74
|
79.03 Score on a scale
Standard Deviation 11.35
|
|
Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)
Visit 3 (n=28 MFNS, n= 23 Placebo)
|
81.56 Score on a scale
Standard Deviation 13.64
|
84.07 Score on a scale
Standard Deviation 12.26
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: The ITT population included all randomized participants who received \>= 1 dose after commencement of treatment. At baseline (visit 2), 28 randomized participants were between 8-12 years old, 15 participants in MFNS \& 13 participants in Placebo group. Questionnaire was answered in accordance with the actual age of each participant at each visit.
The impact on quality of life (QOL) was measured by a general pediatric health questionnaire. Versions were self-administered \& answered by participants' parents. This modular instrument consists of 23 items using a 5-point scale: from 0 (never) to 4 (almost always). Items are reversed scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, 4=0. 4 dimensions (physical, emotional, social, \& school functioning) are scored. Total score is sum of all the items over the number of items answered on all the scales. Higher scores indicate a better health related QOL.
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=15 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=18 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)
Visit 2 (n= 15 MFNS, n=13 Placebo)
|
76.014 Score on a scale
Standard Deviation 10.266
|
76.839 Score on a scale
Standard Deviation 10.828
|
|
Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)
Visit 3 (n=15 MFNS, n= 14 Placebo)
|
82.971 Score on a scale
Standard Deviation 15.054
|
84.006 Score on a scale
Standard Deviation 14.033
|
|
Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)
Visit 4 (n=15 MFNS, n=13 Placebo)
|
85.725 Score on a scale
Standard Deviation 12.033
|
83.946 Score on a scale
Standard Deviation 10.023
|
SECONDARY outcome
Timeframe: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)Population: A total of 132 subjects were included in the ITT population. The ITT population included all randomized participants who received \>=1 dose after commencement of treatment. Data summarized in terms of the number of participants providing data at the relevant time point. 1 participant in Placebo group did not answer this questionnaire at baseline.
18 items of the survey were graded on a 7-point ordinal scale. Caregivers were asked to describe how often in the last 4 weeks had the child exhibited specific symptoms according to the following scale: 1: none of the time; 2: hardly any of the time; 3: a little of the time; 4: some of the time; 5: a good bit of the time; 6: most of the time; 7: all of the time. All scores were summed (total score: 18-126). Grading was as follows: * Scores \< 60 suggest a slight impact on health related quality of life (HRQL) * Scores 60-80 suggest a moderate impact * Scores over 80 suggest a great impact
Outcome measures
| Measure |
Mometasone Furoate Nasal Spray (MFNS)
n=66 Participants
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 Participants
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score
Visit 2 (n=66 MFNS, n=65 Placebo)
|
62.742 Score on a scale
Standard Deviation 19.951
|
60.169 Score on a scale
Standard Deviation 19.123
|
|
Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score
Visit 3 (n=65 MFNS, n= 65 Placebo)
|
47.138 Score on a scale
Standard Deviation 18.806
|
48.769 Score on a scale
Standard Deviation 18.748
|
|
Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score
Visit 4 (n=62 MFNS, n= 59 Placebo)
|
42.742 Score on a scale
Standard Deviation 17.880
|
43.068 Score on a scale
Standard Deviation 18.870
|
Adverse Events
Mometasone Furoate Nasal Spray
Placebo Nasal Spray
Serious adverse events
| Measure |
Mometasone Furoate Nasal Spray
n=66 participants at risk
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 participants at risk
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
Infections and infestations
Appendicitis
|
1.5%
1/66 • Number of events 1 • Up to Week 24
|
0.00%
0/66 • Up to Week 24
|
|
Infections and infestations
Orchitis
|
0.00%
0/66 • Up to Week 24
|
1.5%
1/66 • Number of events 1 • Up to Week 24
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/66 • Up to Week 24
|
1.5%
1/66 • Number of events 1 • Up to Week 24
|
|
Infections and infestations
Pneumonia
|
0.00%
0/66 • Up to Week 24
|
1.5%
1/66 • Number of events 1 • Up to Week 24
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
1.5%
1/66 • Number of events 1 • Up to Week 24
|
0.00%
0/66 • Up to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/66 • Up to Week 24
|
1.5%
1/66 • Number of events 1 • Up to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/66 • Up to Week 24
|
1.5%
1/66 • Number of events 1 • Up to Week 24
|
Other adverse events
| Measure |
Mometasone Furoate Nasal Spray
n=66 participants at risk
1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
Placebo Nasal Spray
n=66 participants at risk
1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
|
|---|---|---|
|
General disorders
Pyrexia
|
7.6%
5/66 • Number of events 10 • Up to Week 24
|
6.1%
4/66 • Number of events 5 • Up to Week 24
|
|
Infections and infestations
Nasopharyngitis
|
4.5%
3/66 • Number of events 3 • Up to Week 24
|
6.1%
4/66 • Number of events 4 • Up to Week 24
|
|
Infections and infestations
Pharyngitis
|
6.1%
4/66 • Number of events 7 • Up to Week 24
|
4.5%
3/66 • Number of events 4 • Up to Week 24
|
|
Infections and infestations
Pharyngotonsillitis
|
3.0%
2/66 • Number of events 2 • Up to Week 24
|
6.1%
4/66 • Number of events 6 • Up to Week 24
|
|
Infections and infestations
Sinusitis
|
6.1%
4/66 • Number of events 5 • Up to Week 24
|
3.0%
2/66 • Number of events 2 • Up to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.5%
1/66 • Number of events 1 • Up to Week 24
|
6.1%
4/66 • Number of events 4 • Up to Week 24
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
3/66 • Number of events 4 • Up to Week 24
|
6.1%
4/66 • Number of events 14 • Up to Week 24
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator agrees not to publish or publicly present any interim results of the Study without prior written consent of the SPONSOR. The Principal Investigator further agrees to provide thirty (30) days written notice to the SPONSOR prior to submission for publication or presentation to permit the SPONSOR to review copies of abstracts or manuscripts for publication which report any results of the Study.
- Publication restrictions are in place
Restriction type: OTHER