A Randomised, Open Label, Interventional Study Evaluating the Efficacy & Safety of Dry Powder Ivy Extract (Syrup Prospan) Versus NAC Among COPD Patients (SyProNAC Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact.
研究概览
简要总结
As the third global leading cause of death, Chronic Obstructive Pulmonary Disease (COPD) affects more than 300 million people worldwide. These patients suffer from 0.5-3.5 exacerbations per year on average. Each exacerbations dampened their health status as well as quality of life, not to mention a great burden to our healthcare system. Those partially treated or prolonged exacerbations would subsequently lead to unfavorable disease progression. Hence a holistic approach in managing each exacerbations is very crucial.
Mucus hypersecretion in COPD patients plays a pivotal role in acute exacerbations and associated with unfavorable outcomes. These exacerbations comes with sputum increment as much as its purulence. Mucolytics are believed to to ease patient to expectorate and benefits them from tip into an exacerbations or even the consequent hospitalisation.
Mucolytics work by reducing sputum viscosity hence improved its expectoration. N-acetylcysteine (NAC) is a mucolytic with antioxidant and anti-inflammatory properties, commonly used in practice among COPD patients. Meanwhile, Syrup Prospan is ivy leaf preparations, obtained as extracts from leaves of the plant Hedera helix L. It is widely used over-the-counter cough remedy containing saponins which are believed to have expectorant properties. Studies show evidence of antispasmodic, bonchodilating, anti-inflammatory and antitussive properties and its usage is authorised by the European Medicines Agency .
详细描述
Hypothesis
- Syrup Prospan is non inferior to NAC - no significant difference of cough symptoms and its impact on daily activities, health related quality of life, as well as lung function test at 30 days of treatment
- Patients received Syrup Prospan has higher satisfaction score compared to N-Acetylcysteine
This is a randomised, open label, interventional study evaluating the efficacy and safety of dry powder Ivy Extract (Syrup Prospan) versus NAC among COPD patients. Randomization 1:1 to received either N.Acetylcysteine 600 mg BD or Syrup Prospan 7.5mls BD (Block randomization)
The study will be conducted from April 2024 to November 2026 This is a prospective interventional study conducted on COPD patients under the Respiratory Unit, Department of Internal Medicine in HCTM, who qualified both the inclusion and exclusion criteria. Patients will be briefed about this study.
Subsequently, consent will be obtained from those who are agree to participate from the patient him/herself.
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with documented post bronchodilator FEV1/FVC < 70 or <LLN
- •Age 40 years and above
- •Able to perform spirometry
- •Participant with Stable COPD based on GOLD 2023 strategy
排除标准
- •Diagnosis of other chronic lung diseases: Asthma, Asthma-COPD Overlap, Interstitial Lung Disease, Bronchiectasis, Lung Cancer
- •Participants with contraindication for spirometry: recent cardiac complications, major surgery, severe advanced respiratory disease, or those with cognitively or neurologically impairment
- •Hypersensitivity to acetylcysteine or any component of the formulation
- •Hypersensitivity to dry powder ivy extract
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG (human Chorionic Gonadotropin) laboratory test
- •Participant on pre-existing regular mucolytics (at least 1 month prior)
- •Illiterate participants
研究组 & 干预措施
Participant with stable COPD who received Syrup prospan
Participant who fulfiled inclusion criteria with stable COPD and received Syrup prospan for 1 month
干预措施: Syrup Prospan (Drug)
Participant with stable COPD who received N-Acetylcysteine
Participant who fulfiled inclusion criteria with stable COPD and received SN-Acetylcysteine for 1 month
干预措施: N-Acetylcysteine (Drug)
结局指标
主要结局
To assess cough symptoms and its impact on daily activities using Cough and Sputum Assessment Questionnaire (CASA-Q); scores for each domain range from 0 to 100, with higher scores indicating fewer/less severe symptoms and less impact.
时间窗: From the time of randomization to the time of the end of study up to 30 days post randomization
Participants with COPD who received either Syrup Prospan or N-Acetylcysteine
次要结局
- to determine change of Quality of Life using McGill COPD Quality of Life Questionnaire, scores ranged from 0 to 100, with higher scores indicating a better quality of life.(From the time of randomization to the time of the end of study up to 30 days post randomization)
- to determine change of Forced Expiratory Volume at 1second (FEV1); in litres/minute using spirometry(From the time of randomization to the time of the end of study up to 30 days post randomization)
- to determine change of Forced Vital Capacity in litres/minute using spirometry(From the time of randomization to the time of the end of study up to 30 days post randomization)
- to determine adverse effects of Syrup Prospan (in %)(From the time of randomization to the time of the end of study up to 30 days post randomization)
- to determine adverse effects of N-Acetylcysteine (in %)(From the time of randomization to the time of the end of study up to 30 days post randomization)
- To assess satisfaction of treatment using the 5 point Likert Scale (1- Not Satisfied, 5 - Most Satisfied)(From the time of randomization to the time of the end of study up to 30 days post randomization)