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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
132
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).
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).
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)
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)
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)