NCT00552032已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 132
- 主要终点
- Change From Baseline in Adenoid/Choana (A/C) Index Grade
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mometasone Furoate nasal spray
Experimental
干预措施: Mometasone Furoate nasal spray (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Adenoid/Choana (A/C) Index Grade
时间窗: 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.
次要结局
- Number of Participants With Bilateral Tympanogram Results of: Normal, Abnormal, or Not Done(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Flow at 75 Pa(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(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Number of Participants With Rhinoscopic-Inferior Turbinates Results of: Normal, Hypertrophic, and Hypotrophic(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Rhinomanometry Results- Left and Right Nasal Fossa: Inspiratory Resistance(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(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Total Severity Symptom Scores: Morning and Evening (AM & PM)(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Total Frequency Symptom Scores: AM & PM(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Rhinomanometry Results- Left and Right Nasal Fossa: Inspiration Flow at 75 Pa(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- 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 Results- Nasopharyngeal Volume (NPV): Left and Right Nasal Fossa(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Number of Participants With Otoscopic Results of: Normal or Abnormal(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(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Rhinomanometry Results- Left and Right Nasal Fossa: Expiratory Resistance(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(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Quality of Life Questionnaire (PedsQL) Total Score (Ages 8-12)(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Quality of Life Questionnaire (PedsQL) Total Score (Ages 2-4)(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Quality of Life Questionnaire (PedsQL) Total Score (Ages 5-7)(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
- Obstructive Sleep Apnea-18 (OSA-18) Questionnaire Total Score(Baseline (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4))
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