Adenoids HypertrophyPhase 3SNORENCT00552032
Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy. SNORE Study (P05155)
A Phase 3 study testing Mometasone Furoate nasal spray in people with Adenoids Hypertrophy, run by Organon and Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 11 years
- Conditions the study is for
- Adenoids Hypertrophy
- What is being tested?
- Mometasone Furoate nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2007to 1 Jan 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
About this study
Official title: A Double-blind Placebo-controlled, Randomized, Parallel-group, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy SNORE Study
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.
- Conditions
- Adenoids Hypertrophy
- Being tested
- Mometasone Furoate nasal spray, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mometasone Furoate nasal sprayDrug
Also called SCH 032088
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).
PlaceboDrug
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).
| Study group | Role | What they receive |
|---|---|---|
| Mometasone Furoate nasal spray | Experimental | Not described Receives: Drug: Mometasone Furoate nasal spray |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)
Secondary outcomes (19)
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.
Measured: 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.
Measured: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2007 (estimated)
- Study start1 Aug 2007
- Primary completion1 Jan 2010
- Study completion1 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenoids HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00552032
- Sponsor's protocol ID
- P05155
- Acronym
- SNORE
- Status last verified
- Feb 2022
- First submitted
- 31 Oct 2007
- Last updated
- 20 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Placebo-controlled, Randomized, Parallel-group, Multicenter Clinical Trial to Evaluate Efficacy and Safety of Mometasone Furoate Nasal Spray in Children With Adenoid Hypertrophy SNORE Study
- ClinicalTrials.gov ID
- NCT00552032
- Acronym / sponsor ID
- SNORE / P05155
- Conditions
- Adenoids Hypertrophy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2007 (actual)
- Primary completion
- 1 Jan 2010 (actual)
- Study completion
- 1 Jan 2010 (actual)
- First posted
- 1 Nov 2007 (estimated)
- Results
- Posted 31 Jan 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mometasone Furoate nasal spray | Experimental | Drug: Mometasone Furoate nasal spray |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 2 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mometasone Furoate nasal sprayAlso: SCH 032088Mometasone 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). | Drug | Mometasone Furoate nasal spray |
| PlaceboPlacebo 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). | Drug | Placebo |
Primary outcome
Change From Baseline in Adenoid/Choana (A/C) Index Grade
Time frame: 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.
19 secondary outcomes
Total Severity Symptom Scores: Morning and Evening (AM & PM)
Time frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Total Frequency Symptom Scores: AM & PM
Time frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done
Time frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Number of Participants With Otoscopic Results of: Normal or 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
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
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
Time frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance
Time frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance
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
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
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
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
Time frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Acoustic Rhinometry Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa
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
Time frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)
Time frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)
Time frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)
Time frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score
Time frame: Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mometasone Furoate nasal spray in people with Adenoids Hypertrophy, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Adenoid/Choana (A/C) Index Grade (time frame: Baseline (visit 2), Weeks 4 (visit 3), Week 8 (visit 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.