CTRI/2020/05/025374已完成3 期
A Prospective, Interventional, Double-blind, Randomized, Placebo-Controlled Parallel Group Clinical Study to evaluate the safety and efficacy of Serracor-NK® and Serra Rx260 on improving symptoms and quality of life in patients with idiopathic pulmonary fibrosis
Advanced Enzyme Technologies Ltd10 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年1月6日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 10
- 主要终点
- 2 Symptoms of IPF, as assessed by change in score for “Symptom†domain of St. George Respiratory Questionnaire
研究概览
简要总结
AProspective, Interventional, Double-blind, Randomized, Placebo-ControlledParallel Group Clinical Study to evaluate the safety and efficacy ofSerracor-NK® and Serra Rx260 on improving symptoms andquality of life in patients with idiopathic pulmonary fibrosis.
Durationof the study for the subject will be 176 days (Approximately 6 month)
| Total of 100 subjects will be enrolled in the study. |
- Test (n=50 randomized)
- Placebo (n=50 randomized
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Clinical diagnosis of Idiopathic pulmonary fibrosis (IPF) within the last 3 years from screening based upon the American Thoracic Society/ European Respiratory Society Consensus Statement.
- •2 Male or female patients aged more than 18 years at screening.
- •3 Forced vital capacity (FVC) more than 50% of predicted normal.
排除标准
- •1 Patients with HRCT Pattern of Probable / Indeterminate for UIP 2 Patients currently on Extracorporeal Membrane Oxygenation 3 Patients with acute IPF exacerbation or any respiratory tract infection within the four weeks prior to the screening period; 4 Alanine transaminase (ALT), Aspartate aminotransferase (AST) more than 1.5-fold upper limit of normal (ULN) 5 Total bilirubin more than 1.5-fold ULN 6 Relevant airways obstruction pre-bronchodilator Forced expiratory volume in 1 second / Forced vital capacity less than 0.70 7 History of Acute Coronary Syndrome 8 Subjects on herbal or mineral preparations for the treatment of IPF.
- •9 Pneumonia diagnoses by High-resolution computed tomography (HRCT) will be performed at the time of screening.
- •10 Planned major surgery during the trial participation, including lung transplantation, major abdominal or major intestinal surgery; 11 A disease or condition which in the opinion of the investigator may interfere with testing procedures or put the patient at risk when participating in this trial; 12 Alcohol or drug abuse which in the opinion of the treating physician would interfere with the treatment and would affect patient’s ability to participate in this trial; 13 Patients not able to understand and follow any study procedures such as but not limited to home spirometry, including completion of self-administered questionnaires without help; 14 Women who are pregnant, nursing, who plan to become pregnant while in the trial; 15 Women of childbearing potential not willing or able to use highly effective methods of birth control.
- •16 Patients who are or have been participating in another trial with investigational drugs within one month prior to screening.
结局指标
主要结局
2 Symptoms of IPF, as assessed by change in score for “Symptom†domain of St. George Respiratory Questionnaire
时间窗: From day 1 to day 176
1. To evaluate the effects of Serracor-NK® and Serra Rx260 on pulmonary fibrosis symptoms using UCSD shortness-of-breath (UCSD-SOB) questionnaire
时间窗: From day 1 to day 176
3 To assess the quality of life of patients as perceived by overall wellbeing and mental wellbeing in patients with IPF using
时间窗: From day 1 to day 176
a)UCSD-SOB
时间窗: From day 1 to day 176
b)SGRQ
时间窗: From day 1 to day 176
c)WHO (Five) Well-Being Index (WHO-WBI)
时间窗: From day 1 to day 176
次要结局
- 1. To evaluate the effect of Serracor-NK® and Serra Rx260 as assessed by rate of decline in “Forced Vital Capacity (FVC)†in spirometry(2 Monitoring of AE and SAE)
研究者
研究点 (10)
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