NCT03591068已完成3 期
A 24-Week Open-Label Study Evaluating the Efficacy and Safety of OPN-375 186 μg Twice a Day (BID) in Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video
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
- 11
- 试验地点
- 2
- 主要终点
- Change From Visit 1 at End of Study in Bilateral Nasal Polyp Grade Using Endoscopic Video
研究概览
简要总结
This is a 24-week, open-label, multi-center study designed to assess the efficacy and safety of OPN-375 186 μg twice a day in subjects with nasal polyps using Nasoendoscopic video. The total planned number of subjects is approximately 10, with each subject receiving OPN-375 186 μg twice a day.
详细描述
The primary objective of this study is to evaluate the efficacy and safety of OPN-375 186 μg twice a day in adults with Bilateral Nasal Polyps using Nasoendoscopic video. The secondary objectives of this study are to evaluate the safety of OPN-375 via adverse event reports, vital signs, and nasal examination. In addition, to measure any change in subject symptoms and functioning from Baseline to 12 and 24 weeks during the study, using the Sinonasal Outcome Test -22 (SNOT-22), Patient's Global Impression of Change (PGIC), and measurement of nasal polyps by independent, blinded reader, and any changes throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Men or women aged 18 years and older at Visit 1 (Baseline/Day1)
- •Women of child bearing potential must be abstinent, or if sexually active,
- •be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [e.g., condoms, diaphragm, or cervical cap with spermicidal foam, cream, or gel], or male partner sterilization) before entry and throughout the study, or
- •be surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), or
- •be postmenopausal (amenorrhea for at least 1 year).
- •Women of child-bearing potential must have a negative urine pregnancy test at Visit 1 (Day 1/Baseline)
- •Must have bilateral nasal polyposis with a grade of 2 or 3 in at least one side of the nasal cavity as determined by a nasal polyp grading scale score measured by nasoendoscopy at Visit 1 (Day 1/Baseline)
- •Must have a SNOT-22 score of ≥20 at Visit 1(Baseline/Day 1)
- •Must have been on an adequate dose of an intranasal corticosteroid (e.g. fluticasone propionate, fluticasone furoate, mometasone, triamcinolone, ciclosenide, budesonide, budesonide respules, beclomethasone) for at least 1 month, in the previous 3 months prior to Visit 1 (Day 1/Baseline)
- •Subjects with comorbid asthma or chronic obstructive pulmonary disease (COPD) must be stable with no exacerbations (e.g., no emergency room visits, hospitalization, or oral or parenteral steroid use) within the 3 months before the screening visit. Inhaled corticosteroid use must be limited to stable doses of no more than 1,000 μg/day of beclomethasone (or equivalent) for at least 3 months before screening with plans to continue use throughout the study
- •Must be able to cease treatment with oral steroids, intranasal steroids, inhaled corticosteroids (except permitted doses listed above for asthma and COPD) at Visit 1 (Day 1/Baseline)
- •Must demonstrate correct use of the demo EDS
- •Ability to read and speak English
- •Must be capable, in the opinion of the investigator, of providing informed consent to participate in the study. Subjects must sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
排除标准
- •Women who are pregnant or lactating
- •Inability to have each nasal cavity examined for any reason, including nasal septum deviation
- •Have used XHANCE™ (fluticasone propionate) nasal spray within the past 2 months
- •Nasal septum perforation
- •Has had more than 1 episode of epistaxis with frank bleeding in the month before Visit 1 (Day 1/Baseline)
- •Have evidence of significant mucosal injury or ulceration (e.g. exposed cartilage) on Visit 1 (Day 1/Baseline) nasal examination/nasoendoscopy
- •History of sinus or nasal surgery within 3 months before Visit 1 (Day 1/Baseline). If >3 months subject should be fully recovered from surgery
- •Current, ongoing rhinitis medicamentosa (rebound rhinitis)
- •Have significant oral structural abnormalities, e.g., a cleft palate
- •Diagnosis of cystic fibrosis
- •History of Churg-Strauss syndrome or dyskinetic ciliary syndromes
- •Purulent nasal infection, acute sinusitis, or upper respiratory tract infection within 2 weeks before Visit 1 (Day 1/Baseline). Potential subjects presenting with any of these infections may be rescreened 4 weeks after symptom resolution
- •Planned sinonasal surgery during the period of the study
- •Allergy, hypersensitivity, or contraindication to corticosteroids, steroids, or to any excipients in OPN-375
- •Exposure to any glucocorticoid treatment with potential for systemic effects (e.g., oral, parenteral, intra-articular, or epidural steroids, high dose topical steroids) within 1 month before Visit 1 (Day 1/Baseline); except as noted in inclusion criteria for subjects with comorbid asthma or COPD
- •Have nasal candidiasis at Visit 1 (Day 1/Baseline)
- •History or current diagnosis of any form of glaucoma, ocular hypertension, or intraocular pressure elevation on any form of steroid therapy
- •History or current diagnosis of the presence (in either eye) of a sub-capsular cataract
- •Any serious or unstable concurrent disease, psychiatric disorder, or any significant condition that, in the opinion of the investigator could confound the results of the study or could interfere with the subject's participation or compliance in the study
- •Recent (within 1 year of Visit 1 (Day 1/Baseline)) history of drug or alcohol abuse, or dependence that, in the opinion of the investigator could interfere with the subject's participation or compliance in the study
- •Have participated in an investigational drug clinical trial within 30 days of Visit 1 (Day 1/Baseline)
- •Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
研究组 & 干预措施
OPN-375 186 mcg BID
Experimental
干预措施: Fluticasone Propionate (Drug)
结局指标
主要结局
Change From Visit 1 at End of Study in Bilateral Nasal Polyp Grade Using Endoscopic Video
时间窗: Week 24
: Polyp grading of each nasal cavity was determined by a nasal polyp grading scale score measured by nasoendoscopy. 0: No polyps 1. Mild polyposis: polyps not reaching below the inferior border of the middle turbinate 2. Moderate polyposis: polyps reaching below the inferior border of the middle concha, but not the inferior border of the inferior turbinate 3. Severe polyposis large polyps reaching below the lower inferior border of the inferior turbinate
次要结局
- Assessment for Safety by Recording Adverse Events and Adverse Events of Special Interests(24 Weeks, up to 30 days after last dose)
- Assessment for Safety Through Nasal Examination(24 Weeks, up to 30 days after last dose)
- Assessment for Safety From Recording Vital Sign - Blood Pressure(Baseline, Week 12, Week 24)
- Assessment for Safety From Recording Vital Sign - Pulse(Baseline, Week 12, Week 24)
- Number of Subjects With a Change of Greater Than or Equal to 1 Point in Bilateral Polyp Grade(Week 24)
- Number of Subjects With a Polyp Grade of 0 on at Least One Side of the Nose at Each Visit(Week 24)
- Sinonasal Outcome Test 22 (SNOT-22) Total Score(Week 24)
- Total Polyp Grading Score (Sum of Scores From Both Nasal Cavities)(Week 24)
- Sniffin' Sticks N-butanol Test(Week 24)
- Number of Participants With a PGIC Score of Minimally/Much/Very Much Improved(Week 24)
- Assessment for Safety From the Collection of Information for Concomitant Medications Usage(24 Weeks, up to 30 days after last dose)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney DiseaseChronic Hepatitis CHepatitis C VirusCompensated CirrhosisSevere Renal ImpairmentEnd-stage Renal DiseaseNCT02207088AbbVie68
Unknown
4 期
Combined Therapy With Peginterferon Alfa-2a With NA in NA-treated HBeAg Positive PatientsChronic Hepatitis BNCT02474316Ruijin Hospital366
撤回
不适用
Oxulumis®, Suprachoroidal Drug Administration of Triesence® in Diabetic Macular EdemaDiabetic Macular EdemaNCT05172401Oxular Limited
已完成
3 期
Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients With Dyslipidemia (OCEANS)HypercholesterolemiaNCT00080275Kos Pharmaceuticals600
撤回
3 期
Efficacy and Safety of Obatoclax Mesylate in Combination With Carboplatin and Etoposide Compared With Carboplatin and Etoposide Alone in Chemotherapy-Naive Patients With Extensive-Stage Small Cell Lung CancerExtensive-stage Small Cell Lung CancerNCT01563601Cephalon