Adults 2 to 11, any sex, with Adenoids Hypertrophy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Change From Baseline in Adenoid/Choana (A/C) Index GradePrimary· Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)
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.
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
Visit 2 AM (n=66 MFNS, n=66 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
9.4
± 2.5
Placebo Nasal Spray
9.9
± 3.3
Visit 3 AM (n=64 MFNS, n=65 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
5.4
± 3.8
Placebo Nasal Spray
6.4
± 3.7
Visit 4 AM (n=62 MFNS, n=60 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
4.2
± 3.6
Placebo Nasal Spray
5.5
± 3.5
Visit 2 PM (n=66 MFNS, n=66 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
9.9
± 3.2
Placebo Nasal Spray
10.2
± 2.8
Visit 3 PM (n=64 MFNS, n=65 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
6.3
± 3.7
Placebo Nasal Spray
7.0
± 3.6
Visit 4 PM (n=62 MFNS, n=60 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
4.8
± 3.8
Placebo Nasal Spray
5.7
± 3.8
Total Frequency Symptom Scores: AM & PMSecondary· Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
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 bot
Visit 2 AM (n=66 MFNS, n=66 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
7.3
± 1.9
Placebo Nasal Spray
7.3
± 2.4
Visit 3 AM (n=64 MFNS, n=65 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
4.4
± 2.7
Placebo Nasal Spray
5.4
± 2.6
Visit 4 AM (n=62 MFNS, n=60 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
3.7
± 2.8
Placebo Nasal Spray
4.4
± 2.5
Visit 2 PM (n=66 MFNS, n=66 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
7.6
± 2.2
Placebo Nasal Spray
8.0
± 2.1
Visit 3 PM (n=64 MFNS, n=65 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
5.3
± 2.8
Placebo Nasal Spray
5.7
± 2.6
Visit 4 PM (n=62 MFNS, n=60 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
4.1
± 2.9
Placebo Nasal Spray
4.6
± 2.7
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not DoneSecondary· Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
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).
Visit 2- Normal (n=66 MFNS, n=66 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
35
Placebo Nasal Spray
39
Visit 2- Abnormal (n=66 MFNS, n=66 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
25
Placebo Nasal Spray
22
Visit 2- Not Done (n=66 MFNS, n=66 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
6
Placebo Nasal Spray
5
Visit 3- Normal (n=65 MFNS, n=65 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
44
Placebo Nasal Spray
33
Visit 3- Abnormal (n=65 MFNS, n=65 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
14
Placebo Nasal Spray
22
Visit 3- Not Done (n=65 MFNS, n=65 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
7
Placebo Nasal Spray
10
Visit 4- Normal (n=62 MFNS, n=60 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
45
Placebo Nasal Spray
39
Visit 4- Abnormal (n=62 MFNS, n=60 Placebo)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
16
Placebo Nasal Spray
19
Number of Participants With Otoscopic Results of: Normal or AbnormalSecondary· Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
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).
Right Otoscopy: Visit 2- Normal (n=66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
50
Placebo Nasal Spray
51
Right Otoscopy: Visit 2- Abnormal (n=66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
16
Placebo Nasal Spray
15
Right Otoscopy Visit 3- Normal (n=65, n=65)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
54
Placebo Nasal Spray
53
Right Otoscopy Visit 3- Abnormal (n=65, n=65)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
11
Placebo Nasal Spray
12
Right Otoscopy Visit 4- Normal (n=62, n=60)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
49
Placebo Nasal Spray
52
Right Otoscopy Visit 4- Abnormal (n=62, n=60)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
13
Placebo Nasal Spray
8
Left Otoscopy: Visit 2- Normal (n=66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
49
Placebo Nasal Spray
52
Left Otoscopy: Visit 2- Abnormal (n=66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
17
Placebo Nasal Spray
14
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive DeviationSecondary· Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
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.
Visit 2 Aligned (n= 66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
65
Placebo Nasal Spray
63
Visit 2 Non-obstructive Deviation (n= 66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
1
Placebo Nasal Spray
3
Vist 2 Obstructive Deviation (n=66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
0
Placebo Nasal Spray
0
Visit 3 Aligned (n=65, n=65)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
64
Placebo Nasal Spray
62
Visit 3 Non-obstructive Deviation (n=65, n=65)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
1
Placebo Nasal Spray
3
Visit 3 Obstructive Deviation (n=65, n=65)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
0
Placebo Nasal Spray
0
Visit 4 Aligned (n=62, n=60)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
61
Placebo Nasal Spray
57
Visit 4 Non-obstructive Deviation (n=62, n=60)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
1
Placebo Nasal Spray
3
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and HypotrophicSecondary· Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
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).
Visit 2- Normal Appearance (n=66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
50
Placebo Nasal Spray
46
Visit 2 Hypertrophic (n=66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
16
Placebo Nasal Spray
20
Vist 2 Hypotrophic (n=66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
0
Placebo Nasal Spray
0
Visit 3 Normal Appearance (n=65, n=65)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
46
Placebo Nasal Spray
48
Visit 3 Hypertrophic (n=65, n=65)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
19
Placebo Nasal Spray
17
Visit 3 Hypotrophic (n=65, n=65)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
0
Placebo Nasal Spray
0
Visit 4 Normal Appearance (n=62, n=60)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
45
Placebo Nasal Spray
42
Visit 4 Hypertrophic (n=62, n=60)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
17
Placebo Nasal Spray
18
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total ObstructionSecondary· Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
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).
Visit 2- Patent (n=66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
62
Placebo Nasal Spray
60
Visit 2- Partial Obstruction (n=66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
3
Placebo Nasal Spray
5
Visit 2- Total Obstruction (n=66, n=66)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
1
Placebo Nasal Spray
1
Visit 3- Patent (n=65, n=65)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
61
Placebo Nasal Spray
61
Visit 3- Partial Obstruction (n=65, n=65)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
4
Placebo Nasal Spray
2
Visit 3- Total Obstruction (n=65, n=65)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
0
Placebo Nasal Spray
2
Visit 4- Patent (n=62, n=60)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
56
Placebo Nasal Spray
53
Visit 4- Partial Obstruction (n= 62, n=60)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
6
Placebo Nasal Spray
4
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory ResistanceSecondary· Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
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).
Visit 2- Left Nasal Fossa (n=19, n=20)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
2.111
± 4.372
Placebo Nasal Spray
3.280
± 7.852
Visit 3- Left Nasal Fossa (n=18, n=18)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
6.341
± 22.759
Placebo Nasal Spray
1.934
± 2.234
Visit 4- Left Nasal Fossa (n=19, n=19)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
31.074
± 131.718
Placebo Nasal Spray
54.724
± 229.437
Visit 2- Right Nasal Fossa (n=19, n=20)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
2.985
± 8.527
Placebo Nasal Spray
6.535
± 24.836
Visit 3- Right Nasal Fossa (n=18, n=18)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
1.823
± 4.454
Placebo Nasal Spray
3.026
± 8.258
Visit 4- Right Nasal Fossa (n=19, n=19)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
2.560
± 6.918
Placebo Nasal Spray
43.621
± 174.535
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory ResistanceSecondary· Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
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).
Visit 2- Left Nasal Fossa (n=19, n=20)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
1.771
± 2.764
Placebo Nasal Spray
3.994
± 9.416
Visit 3- Left Nasal Fossa (n=18, n=18)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
2.937
± 8.196
Placebo Nasal Spray
1.478
± 1.647
Visit 4- Left Nasal Fossa (n=19, n=19)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
13.488
± 32.344
Placebo Nasal Spray
4.148
± 13.999
Visit 2- Right Nasal Fossa (n=19, n=20)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
2.625
± 6.868
Placebo Nasal Spray
1.083
± 1.109
Visit 3- Right Nasal Fossa (n=18, n=18)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
2.189
± 4.678
Placebo Nasal Spray
3.646
± 8.313
Visit 4- Right Nasal Fossa (n=19, n=19)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
0.961
± 0.758
Placebo Nasal Spray
2.792
± 6.318
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 PaSecondary· Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
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.
Visit 2- Left Nasal Fossa (n=19, n=20)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
200.530
± 140.492
Placebo Nasal Spray
178.933
± 129.272
Visit 3- Left Nasal Fossa (n=18, n=18)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
222.152
± 141.740
Placebo Nasal Spray
151.268
± 130.115
Visit 4- Left Nasal Fossa (n=19, n=19)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
194.208
± 100.746
Placebo Nasal Spray
172.346
± 102.607
Visit 2- Right Nasal Fossa (n=19, n=20)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
183.562
± 121.780
Placebo Nasal Spray
161.958
± 138.673
Visit 3- Right Nasal Fossa (n=18, n=18)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
228.661
± 149.318
Placebo Nasal Spray
197.266
± 123.763
Visit 4- Right Nasal Fossa (n=19, n=19)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
215.400
± 157.794
Placebo Nasal Spray
183.368
± 117.677
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 PaSecondary· Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
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.
Visit 2- Left Nasal Fossa (n=19, n=20)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
190.024
± 146.067
Placebo Nasal Spray
166.930
± 116.802
Visit 3- Left Nasal Fossa (n=18, n=18)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
225.911
± 154.830
Placebo Nasal Spray
173.139
± 151.783
Visit 4- Left Nasal Fossa (n=19, n=19)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
181.026
± 119.728
Placebo Nasal Spray
192.374
± 134.337
Visit 2- Right Nasal Fossa (n=19, n=20)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
160.531
± 117.988
Placebo Nasal Spray
166.302
± 132.754
Visit 3- Right Nasal Fossa (n=18, n=18)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
209.676
± 157.215
Placebo Nasal Spray
209.787
± 151.298
Visit 4- Right Nasal Fossa (n=19, n=19)
Group
Value
95% CI
Mometasone Furoate Nasal Spray (MFNS)
195.108
± 163.411
Placebo Nasal Spray
176.587
± 111.421
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Week 24.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to determine whether 8 weeks treatment with mometasone furoate nasal spray (MFNS), twice daily, is safe and effective in treating adenoid hypertrophy in children.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 20 May 2024
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