Comparing the Efficacy of Triple Therapy and Dual Therapy in COPD Patients using Surfactant Protein-D as a Biomarker : A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- To assess changes in forced expiratory volume in 1 second (FEV1) from baseline, and to explore the relationship between these changes and levels of Surfactant Protein D (SP-D) as a biomarker of lung inflammation.
研究概览
简要总结
Despite the widespread use of these therapies, there is ongoing debate about the timing and benefits of transitioning patients from dual to triple therapy, particularly as their disease progresses from mild to more
severe stages.
This study seeks to address this gap by randomizing patients who are transitioning from mild to moderate or severe COPD into two treatment groups: those receiving dual therapy and those receiving triple therapy.
Through this randomized controlled trial, we aim to evaluate and compare the efficacy of these therapeutic approaches in preventing exacerbations, improving lung function, and enhancing quality of life, while also exploring
Surfactant Protein-D (SP-D) as a biomarker of disease activity and treatment response. This study holds particular significance in countries like India, where COPD presents a growing public health challenge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Post bronchodilator FEV1/FVC ration less than 0.70 History of at least 1 moderate or severe exacerbation in the past 12 months Eosinophil count more than 100 cells per microliter CAT score more than 10 or mMRC dyspnea score more than or equal to 2.
排除标准
- •Diagnosis of asthma or other significant respiratory diseases (e.g., pulmonary fibrosis, lung cancer).
- •History of severe cardiovascular diseases (e.g., myocardial infarction, unstable angina, heart failure).
- •Patients with severe cognitive or psychiatric disorders that may impair study participation.
- •History of hypersensitivity to any of the study medications.
- •Active infections requiring antibiotics or systemic steroids at the time of enrollment.
- •Women who are pregnant, and breastfeeding.
结局指标
主要结局
To assess changes in forced expiratory volume in 1 second (FEV1) from baseline, and to explore the relationship between these changes and levels of Surfactant Protein D (SP-D) as a biomarker of lung inflammation.
时间窗: To assess changes in forced expiratory volume in 1 second (FEV1) from baseline,12 and 24 weeks and to explore the relationship between these changes and levels of Surfactant Protein D (SP-D) as a biomarker of lung inflammation.
次要结局
- To assess the impact of BGF triple therapy compared to dual therapy on symptom relief, using the COPD Assessment Test (CAT) & Modified Medical Research Council (mMRC) Dyspnea Scale.(To evaluate changes in quality of life (QoL) between treatment groups, measured by the St. George’s Respiratory Questionnaire (SGRQ).)
研究者
Anusha
SRM college of Pharmacy, SRMIST