Adenoids Hypertrophy
Conditions
Brief summary
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.
Interventions
DRUGMometasone Furoate nasal spray
Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
DRUGPlacebo
Placebo nasal spray 1 puff per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Participants and their parents must demonstrate willingness to participate and comply with study procedures. Parents must sign a written informed consent * Participants and their parents must understand and be able to adhere to dosing and visit schedules, and agree to record symptom severity scores, medication times, and concomitant medications accurately and consistently in a daily diary * Children with a history of adenoid hypertrophy for at least 3 months with no response to previous medical treatment * Baseline adenoid tissue size must have been graded by nasopharyngoscopy examination as Grade III or IV on the Adenoid/Choana (A/C) Index (between 50% and 100% obstruction) * Baseline Total Severity Symptoms Score must be ≥ 8 points (AM or PM) * For inclusion in endpoints relating to otitis media with effusion (OME), participant must have persistent middle ear effusion for the past 3 months or more documented by otoscopic examination, middle ear pressure less than -150 mm H2O, Jerger type B flat tympanogram, and mild-moderate conductive hearing loss in audiometry supporting the diagnosis of OME
Exclusion criteria
* Participants with previous surgery of hypertrophic adenoids with or without tympanostomy tube placement * Participants treated with inhaled or systemic corticosteroids within the past 1 month * Participants with Morbid Obesity (Body Mass Index \>95 percentile of charts from the Centers for Disease Control) * Participants who have not accomplished the designated washout periods for any of the prohibited medications * Participants who have used any investigational products within the last 30 days * Participants who have used any antibodies for allergies in the past 90 days * Participants who have any abnormal physical examination results that may affect study evaluations or participant safety in the investigator's judgment * Participants who are allergic or have an idiosyncratic reaction to corticosteroids * Participants with signs and symptoms of acute or chronic bacterial rhinosinusitis * Participants has had an upper or lower respiratory tract or sinus infection that required antibiotic therapy with the last dose later than 14 days prior to screening, or who has had a viral upper or lower respiratory infection within 7 days prior to screening * Participants with a documented immunodeficiency condition * Participants with nasal structural abnormalities, including large nasal polyps and marked septum deviation that significantly interferes with nasal airflow * Participants with any clinically significant metabolic, cardiovascular, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease (other than asthma), or any other disorder which, in the judgment of the Investigator, may interfere with the study evaluations or affect participant safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Adenoid/Choana (A/C) Index Grade | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Frequency Symptom Scores: AM & PM | 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 both AM (6 symptoms times max frequency of 2) and PM. |
| Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | 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). |
| Number of Participants With Otoscopic Results of: Normal or Abnormal | 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). |
| Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | 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. |
| Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | 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). |
| Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | 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). |
| Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance | 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). |
| Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance | 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). |
| Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa | 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. |
| Total Severity Symptom Scores: Morning and Evening (AM & PM) | Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) | 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. |
| Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done | Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) | 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). |
| Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa | Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) | 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. |
| Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa | Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) | 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. |
| Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe | Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) | 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. |
| Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4) | Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) | 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. |
| Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7) | Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) | 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. |
| Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12) | Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) | 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. |
| Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score | Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4) | 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 |
| Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa | 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. |
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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). | 66 |
| 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). | 66 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 8 | 5 |
| Overall Study | Protocol Violation | 7 | 12 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Mometasone Furoate Nasal Spray | Placebo Nasal Spray | Total |
|---|---|---|---|
| Age, Continuous | 5.56 years STANDARD_DEVIATION 2.27 | 5.36 years STANDARD_DEVIATION 2.5 | 5.46 years STANDARD_DEVIATION 2.38 |
| Sex: Female, Male Female | 32 Participants | 23 Participants | 55 Participants |
| Sex: Female, Male Male | 34 Participants | 43 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 66 | 17 / 66 |
| serious Total, serious adverse events | 2 / 66 | 3 / 66 |
Outcome results
Primary
Change From Baseline in Adenoid/Choana (A/C) Index Grade
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Change From Baseline in Adenoid/Choana (A/C) Index Grade | Change at Visit 3 (n=65 MFNS, n=63 Placebo) | 0.2 Score on a Scale | Standard Deviation 0.5 |
| Placebo Nasal Spray | Change From Baseline in Adenoid/Choana (A/C) Index Grade | Change at Visit 4 (n=61 MFNS, n=58 Placebo) | 0.3 Score on a Scale | Standard Deviation 0.7 |
Secondary
Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa | Visit 3- Right Nasal Fossa (n=18, n=18) | 0.596 cm^3 | Standard Deviation 0.383 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa | Visit 2- Left Nasal Fossa (n=19, n=20) | 0.491 cm^3 | Standard Deviation 0.265 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa | Visit 2- Right Nasal Fossa (n=19, n=20) | 0.577 cm^3 | Standard Deviation 0.381 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa | Visit 3- Left Nasal Fossa (n=18, n=18) | 0.594 cm^3 | Standard Deviation 0.403 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa | Visit 4- Right Nasal Fossa (n=19, n=19) | 0.814 cm^3 | Standard Deviation 0.675 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Minimal Cross-Sectional Area: Left and Right Nasal Fossa | Visit 4- Left Nasal Fossa (n=19, n=19) | 0.661 cm^3 | Standard Deviation 0.444 |
Secondary
Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 1.24 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa | Visit 2- Right Nasal Fossa (n=19, n=20) | 4.489 cm^3 | Standard Deviation 2.941 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa | Visit 2- Left Nasal Fossa (n=19, n=20) | 4.117 cm^3 | Standard Deviation 3.554 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa | Visit 3- Left Nasal Fossa (n=18, n=18) | 3.489 cm^3 | Standard Deviation 1.589 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa | Visit 4- Left Nasal Fossa (n=19, n=19) | 3.084 cm^3 | Standard Deviation 1.724 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa | Visit 3- Right Nasal Fossa (n=19, n=18) | 4.884 cm^3 | Standard Deviation 3.591 |
| Placebo Nasal Spray | Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa | Visit 4- Right Nasal Fossa (n=19, n=19) | 3.275 cm^3 | Standard Deviation 1.083 |
Secondary
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 3- Abnormal (n=65 MFNS, n=65 Placebo) | 14 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 4- Normal (n=62 MFNS, n=60 Placebo) | 45 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 2- Abnormal (n=66 MFNS, n=66 Placebo) | 25 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 4- Abnormal (n=62 MFNS, n=60 Placebo) | 16 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 3- Normal (n=65 MFNS, n=65 Placebo) | 44 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 2- Normal (n=66 MFNS, n=66 Placebo) | 35 Participants |
| Placebo Nasal Spray | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 4- Not Done (n=62 MFNS, n=60 Placebo) | 2 Participants |
| Placebo Nasal Spray | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 2- Normal (n=66 MFNS, n=66 Placebo) | 39 Participants |
| Placebo Nasal Spray | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 2- Abnormal (n=66 MFNS, n=66 Placebo) | 22 Participants |
| Placebo Nasal Spray | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 2- Not Done (n=66 MFNS, n=66 Placebo) | 5 Participants |
| Placebo Nasal Spray | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 3- Normal (n=65 MFNS, n=65 Placebo) | 33 Participants |
| Placebo Nasal Spray | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 3- Not Done (n=65 MFNS, n=65 Placebo) | 10 Participants |
| Placebo Nasal Spray | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 4- Normal (n=62 MFNS, n=60 Placebo) | 39 Participants |
| Placebo Nasal Spray | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 4- Abnormal (n=62 MFNS, n=60 Placebo) | 19 Participants |
| Placebo Nasal Spray | Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done | Visit 3- Abnormal (n=65 MFNS, n=65 Placebo) | 22 Participants |
Secondary
Number of Participants With Otoscopic Results of: Normal or Abnormal
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy: Visit 2- Normal (n=66, n=66) | 50 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy: Visit 2- Abnormal (n=66, n=66) | 16 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy Visit 3- Normal (n=65, n=65) | 54 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy Visit 3- Abnormal (n=65, n=65) | 11 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy Visit 4- Normal (n=62, n=60) | 49 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy Visit 4- Abnormal (n=62, n=60) | 13 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy: Visit 2- Normal (n=66, n=66) | 49 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy: Visit 2- Abnormal (n=66, n=66) | 17 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy Visit 3- Normal (n=65, n=65) | 51 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy Visit 3- Abnormal (n=65, n=65) | 14 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy Visit 4- Normal (n=62, n=60) | 48 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy Visit 4- Abnormal (n=62, n=60) | 14 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy Visit 4- Normal (n=62, n=60) | 52 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy: Visit 2- Normal (n=66, n=66) | 51 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy: Visit 2- Normal (n=66, n=66) | 52 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy: Visit 2- Abnormal (n=66, n=66) | 15 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy Visit 3- Abnormal (n=65, n=65) | 10 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy Visit 3- Normal (n=65, n=65) | 53 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy: Visit 2- Abnormal (n=66, n=66) | 14 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy Visit 3- Abnormal (n=65, n=65) | 12 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy Visit 4- Abnormal (n=62, n=60) | 8 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy Visit 4- Normal (n=62, n=60) | 52 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Left Otoscopy Visit 3- Normal (n=65, n=65) | 55 Participants |
| Placebo Nasal Spray | Number of Participants With Otoscopic Results of: Normal or Abnormal | Right Otoscopy Visit 4- Abnormal (n=62, n=60) | 8 Participants |
Secondary
Number of Participants With Pediatric Sleep Questionnaire (PSQ)- Impact on Health-Related Quality of Life (HRQL) Results of: Mild, Moderate, or Severe
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | 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) | 2 Participants |
| Placebo Nasal Spray | 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) | 30 Participants |
| Placebo Nasal Spray | 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) | 26 Participants |
| Placebo Nasal Spray | 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) | 9 Participants |
| Placebo Nasal Spray | 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) | 45 Participants |
| Placebo Nasal Spray | 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) | 17 Participants |
| Placebo Nasal Spray | 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) | 3 Participants |
| Placebo Nasal Spray | 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) | 47 Participants |
| Placebo Nasal Spray | 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) | 10 Participants |
Secondary
Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done
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).
Time frame: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done | Visit 4- Not Done (n=19 MFNS, n=20 Placebo) | 0 Participants |
| Placebo Nasal Spray | Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done | Visit 2- Normal (n=19 MFNS, n=21 Placebo) | 18 Participants |
| Placebo Nasal Spray | Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done | Visit 2- Abnormal (n=19 MFNS, n=21 Placebo) | 2 Participants |
| Placebo Nasal Spray | 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 |
| Placebo Nasal Spray | Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done | Visit 3- Normal (n=20 MFNS, n=21 Placebo) | 20 Participants |
| Placebo Nasal Spray | Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done | Visit 3- Abnormal (n=20 MFNS, n=21 Placebo) | 1 Participants |
| Placebo Nasal Spray | Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done | Visit 3- Not Done (n=20 MFNS, n=21 Placebo) | 0 Participants |
| Placebo Nasal Spray | Number of Participants With Pure-Tone Audiometric Results of: Normal, Abnormal, or Not Done | Visit 4- Normal (n=19 MFNS, n=20 Placebo) | 18 Participants |
| Placebo Nasal Spray | 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 |
Secondary
Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 2 Hypertrophic (n=66, n=66) | 16 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 3 Hypotrophic (n=65, n=65) | 0 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 3 Normal Appearance (n=65, n=65) | 46 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 4 Normal Appearance (n=62, n=60) | 45 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Vist 2 Hypotrophic (n=66, n=66) | 0 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 4 Hypertrophic (n=62, n=60) | 17 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 3 Hypertrophic (n=65, n=65) | 19 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 4 Hypotrophic (n=62, n=60) | 0 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 2- Normal Appearance (n=66, n=66) | 50 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 4 Hypotrophic (n=62, n=60) | 0 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 2- Normal Appearance (n=66, n=66) | 46 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 2 Hypertrophic (n=66, n=66) | 20 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Vist 2 Hypotrophic (n=66, n=66) | 0 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 3 Normal Appearance (n=65, n=65) | 48 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 3 Hypertrophic (n=65, n=65) | 17 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 3 Hypotrophic (n=65, n=65) | 0 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 4 Normal Appearance (n=62, n=60) | 42 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic | Visit 4 Hypertrophic (n=62, n=60) | 18 Participants |
Secondary
Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction
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).
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | Visit 3- Patent (n=65, n=65) | 61 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | Visit 4- Patent (n=62, n=60) | 56 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | Visit 2- Patent (n=66, n=66) | 62 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | Visit 4- Total Obstruction (n=62, n=60) | 3 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | Visit 2- Patent (n=66, n=66) | 60 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | Visit 2- Partial Obstruction (n=66, n=66) | 5 Participants |
| Placebo Nasal Spray | 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 |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | Visit 3- Patent (n=65, n=65) | 61 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | Visit 3- Partial Obstruction (n=65, n=65) | 2 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | Visit 3- Total Obstruction (n=65, n=65) | 2 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | Visit 4- Patent (n=62, n=60) | 53 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Middle Meatus Results of: Patent, Partial Obstruction or Total Obstruction | Visit 4- Partial Obstruction (n= 62, n=60) | 4 Participants |
Secondary
Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 3 Obstructive Deviation (n=65, n=65) | 0 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 3 Aligned (n=65, n=65) | 64 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 4 Aligned (n=62, n=60) | 61 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Vist 2 Obstructive Deviation (n=66, n=66) | 0 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 4 -Obstructive Deviation (n=62, n=60) | 0 Participants |
| Mometasone Furoate Nasal Spray (MFNS) | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 2 Aligned (n= 66, n=66) | 65 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 4 -Obstructive Deviation (n=62, n=60) | 0 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 2 Aligned (n= 66, n=66) | 63 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 2 Non-obstructive Deviation (n= 66, n=66) | 3 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Vist 2 Obstructive Deviation (n=66, n=66) | 0 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 3 Aligned (n=65, n=65) | 62 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 3 Non-obstructive Deviation (n=65, n=65) | 3 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 3 Obstructive Deviation (n=65, n=65) | 0 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 4 Aligned (n=62, n=60) | 57 Participants |
| Placebo Nasal Spray | Number of Participants With Rhinoscopic- Septum Results of: Aligned, Non-Obstructive, or Obstructive Deviation | Visit 4 Non-obstructive Deviation (n=62, n=60) | 3 Participants |
Secondary
Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score
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
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 17.88 |
| Placebo Nasal Spray | Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score | Visit 2 (n=66 MFNS, n=65 Placebo) | 60.169 Score on a scale | Standard Deviation 19.123 |
| Placebo Nasal Spray | Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score | Visit 3 (n=65 MFNS, n= 65 Placebo) | 48.769 Score on a scale | Standard Deviation 18.748 |
| Placebo Nasal Spray | Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score | Visit 4 (n=62 MFNS, n= 59 Placebo) | 43.068 Score on a scale | Standard Deviation 18.87 |
Secondary
Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4) | Visit 2 (n= 23 MFNS, n=29 Placebo) | 78.017 Score on a scale | Standard Deviation 14.769 |
| Placebo Nasal Spray | Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4) | Visit 3 (n=22 MFNS, n= 28 Placebo) | 78.486 Score on a scale | Standard Deviation 15.707 |
| Placebo Nasal Spray | Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4) | Visit 4 (n=18 MFNS, n=25 Placebo) | 82.701 Score on a scale | Standard Deviation 11.911 |
Secondary
Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7) | Visit 2 (n= 28 MFNS, n=24 Placebo) | 79.03 Score on a scale | Standard Deviation 11.35 |
| Placebo Nasal Spray | Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7) | Visit 3 (n=28 MFNS, n= 23 Placebo) | 84.07 Score on a scale | Standard Deviation 12.26 |
| Placebo Nasal Spray | Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7) | Visit 4 (n=28 MFNS, n=22 Placebo) | 82.71 Score on a scale | Standard Deviation 13.52 |
Secondary
Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12) | Visit 2 (n= 15 MFNS, n=13 Placebo) | 76.839 Score on a scale | Standard Deviation 10.828 |
| Placebo Nasal Spray | Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12) | Visit 3 (n=15 MFNS, n= 14 Placebo) | 84.006 Score on a scale | Standard Deviation 14.033 |
| Placebo Nasal Spray | Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12) | Visit 4 (n=15 MFNS, n=13 Placebo) | 83.946 Score on a scale | Standard Deviation 10.023 |
Secondary
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 154.83 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa | Visit 3- Right Nasal Fossa (n=18, n=18) | 209.787 cm^3/sec | Standard Deviation 151.298 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa | Visit 2- Left Nasal Fossa (n=19, n=20) | 166.930 cm^3/sec | Standard Deviation 116.802 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa | Visit 2- Right Nasal Fossa (n=19, n=20) | 166.302 cm^3/sec | Standard Deviation 132.754 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa | Visit 3- Left Nasal Fossa (n=18, n=18) | 173.139 cm^3/sec | Standard Deviation 151.783 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa | Visit 4- Right Nasal Fossa (n=19, n=19) | 176.587 cm^3/sec | Standard Deviation 111.421 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa | Visit 4- Left Nasal Fossa (n=19, n=19) | 192.374 cm^3/sec | Standard Deviation 134.337 |
Secondary
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance | Visit 3- Right Nasal Fossa (n=18, n=18) | 3.646 Pa/cm^3/sec | Standard Deviation 8.313 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance | Visit 2- Left Nasal Fossa (n=19, n=20) | 3.994 Pa/cm^3/sec | Standard Deviation 9.416 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance | Visit 2- Right Nasal Fossa (n=19, n=20) | 1.083 Pa/cm^3/sec | Standard Deviation 1.109 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance | Visit 3- Left Nasal Fossa (n=18, n=18) | 1.478 Pa/cm^3/sec | Standard Deviation 1.647 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance | Visit 4- Right Nasal Fossa (n=19, n=19) | 2.792 Pa/cm^3/sec | Standard Deviation 6.318 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance | Visit 4- Left Nasal Fossa (n=19, n=19) | 4.148 Pa/cm^3/sec | Standard Deviation 13.999 |
Secondary
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa
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.
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 141.74 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 121.78 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa | Visit 3- Right Nasal Fossa (n=18, n=18) | 197.266 cm^3/sec | Standard Deviation 123.763 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa | Visit 2- Left Nasal Fossa (n=19, n=20) | 178.933 cm^3/sec | Standard Deviation 129.272 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa | Visit 2- Right Nasal Fossa (n=19, n=20) | 161.958 cm^3/sec | Standard Deviation 138.673 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa | Visit 3- Left Nasal Fossa (n=18, n=18) | 151.268 cm^3/sec | Standard Deviation 130.115 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa | Visit 4- Right Nasal Fossa (n=19, n=19) | 183.368 cm^3/sec | Standard Deviation 117.677 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa | Visit 4- Left Nasal Fossa (n=19, n=19) | 172.346 cm^3/sec | Standard Deviation 102.607 |
Secondary
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance | Visit 3- Right Nasal Fossa (n=18, n=18) | 3.026 Pa/cm^3/sec | Standard Deviation 8.258 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance | Visit 2- Left Nasal Fossa (n=19, n=20) | 3.280 Pa/cm^3/sec | Standard Deviation 7.852 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance | Visit 2- Right Nasal Fossa (n=19, n=20) | 6.535 Pa/cm^3/sec | Standard Deviation 24.836 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance | Visit 3- Left Nasal Fossa (n=18, n=18) | 1.934 Pa/cm^3/sec | Standard Deviation 2.234 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance | Visit 4- Right Nasal Fossa (n=19, n=19) | 43.621 Pa/cm^3/sec | Standard Deviation 174.535 |
| Placebo Nasal Spray | Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance | Visit 4- Left Nasal Fossa (n=19, n=19) | 54.724 Pa/cm^3/sec | Standard Deviation 229.437 |
Secondary
Total Frequency Symptom Scores: AM & PM
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Total Frequency Symptom Scores: AM & PM | Visit 3 PM (n=64 MFNS, n=65 Placebo) | 5.7 Score on a scale | Standard Deviation 2.6 |
| Placebo Nasal Spray | Total Frequency Symptom Scores: AM & PM | Visit 2 AM (n=66 MFNS, n=66 Placebo) | 7.3 Score on a scale | Standard Deviation 2.4 |
| Placebo Nasal Spray | Total Frequency Symptom Scores: AM & PM | Visit 2 PM (n=66 MFNS, n=66 Placebo) | 8.0 Score on a scale | Standard Deviation 2.1 |
| Placebo Nasal Spray | Total Frequency Symptom Scores: AM & PM | Visit 3 AM (n=64 MFNS, n=65 Placebo) | 5.4 Score on a scale | Standard Deviation 2.6 |
| Placebo Nasal Spray | Total Frequency Symptom Scores: AM & PM | Visit 4 PM (n=62 MFNS, n=60 Placebo) | 4.6 Score on a scale | Standard Deviation 2.7 |
| Placebo Nasal Spray | Total Frequency Symptom Scores: AM & PM | Visit 4 AM (n=62 MFNS, n=60 Placebo) | 4.4 Score on a scale | Standard Deviation 2.5 |
Secondary
Total Severity Symptom Scores: Morning and Evening (AM & PM)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Mometasone Furoate Nasal Spray (MFNS) | 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 |
| Placebo Nasal Spray | Total Severity Symptom Scores: Morning and Evening (AM & PM) | Visit 3 PM (n=64 MFNS, n=65 Placebo) | 7.0 Score on a scale | Standard Deviation 3.6 |
| Placebo Nasal Spray | Total Severity Symptom Scores: Morning and Evening (AM & PM) | Visit 2 AM (n=66 MFNS, n=66 Placebo) | 9.9 Score on a scale | Standard Deviation 3.3 |
| Placebo Nasal Spray | Total Severity Symptom Scores: Morning and Evening (AM & PM) | Visit 2 PM (n=66 MFNS, n=66 Placebo) | 10.2 Score on a scale | Standard Deviation 2.8 |
| Placebo Nasal Spray | Total Severity Symptom Scores: Morning and Evening (AM & PM) | Visit 3 AM (n=64 MFNS, n=65 Placebo) | 6.4 Score on a scale | Standard Deviation 3.7 |
| Placebo Nasal Spray | Total Severity Symptom Scores: Morning and Evening (AM & PM) | Visit 4 PM (n=62 MFNS, n=60 Placebo) | 5.7 Score on a scale | Standard Deviation 3.8 |
| Placebo Nasal Spray | Total Severity Symptom Scores: Morning and Evening (AM & PM) | Visit 4 AM (n=62 MFNS, n=60 Placebo) | 5.5 Score on a scale | Standard Deviation 3.5 |