NL-OMON48040尚未招募2 期
Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study with Inhaled RVT-1601 for the Treatment of Persistent Cough in Patients with Idiopathic Pulmonary Fibrosis (IPF): SCENIC Trial - RVT1601-CC-04 SCENIC Trial
Respivant Sciences GmBH0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Male or female subjects age 40 through 89 years, inclusive
- •2. Confirmed diagnosis of IPF with clinical features consistent with the
- •current clinical practice guidelines for IPF
- •3. Presence of persistent cough for at least 8 weeks that is primarily due to
- •IPF and not responsive to antitussive therapy
- •4. Daytime cough severity score of >=40 mm on a 100-mm VAS at the Screening
- •5. 24-hour average cough count of at least 10 coughs per hour using an
- •objective cough count monitor during Screening
- •6. Forced Vital Capacity (FVC) >= 45% predicted value within 4 weeks of the
- •Screening Visit
- •7. Life expectancy of at least 12 months
- •8. Willing and able to follow the study required visits and assessments.
- •9. Willing and able to use the cough monitor for 24-hour periods at select
- •study visits
- •11. Willing and able to provide written informed consent prior to study-related
排除标准
- •1. Current or recent history of clinically significant medical condition,
- •laboratory abnormality, or illness that could place the subject at risk or
- •compromise the quality of the study data as determined by the investigator
- •2. Significant coronary artery disease (i.e., myocardial infarction within 6
- •months or unstable angina within 1 month of the Screening Visit)
- •3. An upper or lower respiratory tract infection within 4 weeks of the
- •Screening Visit
- •4. Acute exacerbation of IPF within 6 months of the Screening Visit (Collard et
- •al., 2016)
- •5. Lung transplantation expected within 12 months
- •6. Requiring supplemental O2 >= 4 litres/min to maintain peripheral arterial O2
- •saturation (SpO2) >= 88% at rest
- •7. History of malignancy likely to result in significant disability or likely
- •to require significant medical or surgical intervention within the next 2
- •years. This does not include minor surgical procedures for localized cancer
- •(e.g., basal cell carcinoma, squamous cell, prostate carcinoma or cervical
- •carcinoma in situ)
- •8. Current smoker (i.e., use of tobacco products within the last 3 months)
- •9. Current or recent history of drug or alcohol abuse within 12 months of the
- •Screening Visit
- •10. Participation in any other investigational drug study within 4 weeks of the
- •Screening Visit or within 5 times the elimination half-life of an
- •investigational drug
- •11. Use of the following drugs for cough management within 4 weeks of the
- •Screening Visit: prednisone, opiates, baclofen, gabapentin, pregabalin,
- •thalidomide, amitriptyline, inhaled corticosteroids, or inhaled bronchodilators
- •12. Use of ACE inhibitors or cromolyn sodium within 4 weeks of the Screening
- •13. Females who are pregnant or breastfeeding, or if of child-bearing potential
- •unwilling to practice acceptable means of birth control during the study (e.g.,
- •abstinence, combination barrier and spermicide, hormonal, or male partner
- •sterilization)
- •14. History of hypersensitivity or intolerance to cromolyn sodium or its
- •inactive ingredients
研究者
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