A 24-Week Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 μg of OPN-375 Twice a Day (BID) in Subjects With Chronic Rhinosinusitis With or Without the Presence of Nasal Polyps
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 332
- 试验地点
- 92
- 主要终点
- Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4
研究概览
简要总结
This is a 24-week randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of intranasal administration of 186 and 372 μg twice daily (BID) of OPN-375 in subjects with chronic rhinosinusitis (CS) with or without nasal polyps.
详细描述
The primary objective of this study is to compare the efficacy of intranasal administration of twice-daily doses of 186 and 372 µg of OPN-375 (fluticasone propionate) with placebo in subjects with chronic rhinosinusitis using the following co-primary endpoints:
- A change from baseline in symptoms as measured by a composite score of nasal congestion, facial pain or pressure sensation, and nasal discharge (anterior and/or posterior) at the end of Week 4.
- A change from baseline to Week 24/Early Termination (ET) in the average percent of the volume opacified in the ethmoid and maxillary sinuses.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
OPN-375 186 μg BID
OPN-375 186 μg BID x 24 Weeks
干预措施: OPN-375 (Drug)
OPN-375 372 μg BID
OPN-375 372 μg BID x 24 Weeks
干预措施: OPN-375 (Drug)
Placebo
Matching Placebo BID x 24 Weeks
干预措施: OPN-375 (Drug)
结局指标
主要结局
Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior) at the End of Week 4
时间窗: 4 Weeks
Change from baseline to the end of Week 4 in average total instantaneous AM scores (evaluation of symptom severity immediately preceding the time of scoring) for each symptom: nasal congestion, nasal discharge (anterior and/or posterior), facial pain/pressure sensation. Baseline scores are the averaged total instantaneous AM scores over the last 7 days of the single blind run in period, and the end of Week 4, scores are averaged over the 7 days from the subject diary. Range of scores for each nasal symptom is 0= none, 1 = mild, 2 = moderate, 3 = severe. Composite score is a sum of the 3 symptom scores and will range from 0 to 9.
Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses
时间窗: Baseline, Week 24
Change from baseline to Week 24/ET in the average percent of ethmoid and maxillary sinus volume opacified as measured by CT. Percent volume opacified can range from 0% to 100%. Outcome measure is the percentage change from percent opacification at baseline to percent opacification at Week 24; therefore, change in opacification volume can range from -100% to 100%. For example, if Baseline opacification was 68.22% and Week 24 opacification was 66.11%, then the change would be reported as -2.11%.
次要结局
- Change From Baseline to Defined Timepoint - Subject Symptoms and Functioning as Measured by the Sinonasal Outcome Test - 22-item (SNOT-22) Total Score and Sub Domains(Week 24)
- Change From Baseline in Symptoms as Measured by a Composite Score for Each Symptom of Nasal Congestion, Facial Pain or Pressure Sensation, and Nasal Discharge (Anterior and/or Posterior)(Week 12)
- Comparison of Health Economic Measures- Percentage of Subjects Who Meet the Minimal Objective Criteria for Surgical Intervention(Baseline, Week 24)
- Change in Sense of Smell Scores Measured by AM and PM Diary Symptom Scores(12 Weeks)
- Change From Baseline in Nasal Discharge (Anterior and/or Posterior) Measured by AM and PM Diary Symptom Scores(12 Weeks)
- Change From Baseline in Nasal Congestion Measured by AM and PM Diary Symptom Scores(12 Weeks)
- Change in Facial Pain or Pressure Sensation Measured by AM and PM Diary Symptom Scores(12 Weeks)
- Change From Baseline to Week 24/Early Termination (ET) in the Average Percent of the Volume Opacified in the Ethmoid and Maxillary Sinuses Among Patient Populations(24 Weeks)
- Change From Baseline to Week 24/ET in the Lund-Mackay Staging System Total Score(Baseline, Week 24)
- Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Ethmoids and Maxillary Sinuses Combined(24 Weeks)
- Change From Baseline to Week24/ET in the Lund-Mackay Staging System Total Scores for Sinus Pairs(Week 24)
- Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Ethmoid Sinus as Measured by CT Scan Assessment(Baseline, Week 24)
- Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Sinus Between the Maxillary and Ethmoid Sinuses as Measured by CT Scan Assessment Among Patient Populations(24 Weeks)
- Comparison of Health Economic Measures- Percentage of Subjects Approved for Surgery Who no Longer Elect to Undergo a Surgery(Week 24)
- Change From Baseline to Week 24/ET in Average Percent of Sinus Volume Occupied by Disease in the Worst Maxillary Sinus as Measured by CT Scan Assessment(Baseline, Week 24)
- Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System Total Score(Baseline, Week 24)
- Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for Ethmoids and Maxillary Sinuses Combined(Baseline, Week 24)
- Change in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index (PSQI)(12 Weeks, 24 Weeks)
- Change in Overall Health From Baseline to Week 4 and Week 24/ET as Measured by the Percent of Subjects Improved as Indicated by the Patient Global Impression of Change (PGIC)(Week 4, Week 24)
- Change in the 36-Item Short Form Health Survey Version 2 (SF-36v2) Mental Composite Score (MCS)(24 Weeks)
- Change in Baseline to Week 24/ET as Measured by the Short-Form 36 Health Survey, Version 2 (SF-36v2)(24 Weeks)
- Change in Baseline to Week 24/ET as Measured by the Euroqol 5-dimension (EQ-5D) Instrument Visual Analogue Scale (VAS)(24 Weeks)
- Change in Baseline to Week 24/ET as Measured by the Short-Form 6-Dimension (SF-6D) Instrument(24 Weeks)
- Comparison of Health Economic Measures- Percentage of Subjects Indicating That They Are Willing to Consider Sinus Surgery(Baseline, Week 24)
- Change in Work Productivity From Baseline to Week 24/ET as Measured by the Health and Work Performance Questionnaire (HPQ).(24 Weeks)
- Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Sinus Pairs(Baseline, Week 24)
- Change From Baseline to Week 24/ET in the Zeinrich Modification of Lund-Mackay Staging System for the Worst Sinus Between Maxillary and Ethmoid Sinuses Among Patient Populations(Baseline, Week 24)
- Time Comparison to First Acute Exacerbation of Chronic Sinusitis(24 Weeks)
- Percentage of Subjects Requiring Rescue Medication After Week 4(8 Weeks)
- Severity of Depression at Week 24 as Measured by the Quick Inventory of Depression Symptomatology (QIDS)(Week 24)
- Change in the SF-36v2 Physical Composite Score (PCS)(24 Weeks)
- Change in Depressive Symptoms From Baseline to Week 24/ET as Measured by Change in the Severity of Depression as Measured by the Quick Inventory of Depression Symptomatology (QIDS)(24 Weeks)
- Change in Olfactory Impairment From Baseline to Week 24/ET as Measured by the Smell Identification Test (SIT)™(24 Weeks)