CTRI/2018/03/012417已完成未知
A Prospective, Open label, Single arm, Single Centre Study for Assessment of Efficacy, Safety and Cost analysis of add-on Pidotimod 800mg in maintenance therapy for exacerbation of Chronic Obstructive Pulmonary Disease (COPD) - COPD
Dr Ashish Omprakash Goyal0 个研究点目标入组 119 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 119
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
入选标准
- •1.Adult Patients (>= 18 years and <= 55years) of either sex who are diagnosed with COPD according to GOLD criteria.
- •2.Patient who had two or more exacerbation of COPD that required antibiotics for therapy OR One or more exacerbation requiring hospitalization in last 12 months.
- •3.Patients with FEV1 <= 80% and >= 30%.
- •4.Patients who are clinically stable (No episode of exacerbation) during one month prior to enrolment into study.
- •5.Patients who understand the nature of the study and are willing to provide written informed consent
排除标准
- •1.Patients with known allergic / hypersensitivity reaction to study medication.
- •2.Patients who had received antibiotics or a course of systemic steroids (defined as equivalent to >10 mg of prednisone a day for more than 1 week) within month prior to enrolment in the study.
- •3.Patients suffering from asthma, defined as episodic symptoms of airflow obstruction which is reversible with bronchodilators, assessed with lung function testing.
- •4.Patients known to be suffering from primary immunodeficiency / acquired immunodeficiency viz. HIV
- •5.Patients suffering from comorbid conditions that can affect the immune response viz. diabetes, Anaemia, Hypoalbuminemia.
- •6.Patients suffering from other respiratory disorders viz. tuberculosis
- •7.Patients suffering from such cardiovascular disorders viz. Uncontrolled hypertension, CVD; that may potentially complicate and pose risk to health of the patients
- •8.Patients with co-morbidities requiring medicines that can adversely interact with or interfere with evaluation of study medication.
- •9.Patients suffering from any renal, hepatic or neoplastic disorders
- •10.Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study.
- •11.Female subjects who are pregnant or are currently breast-feeding.
- •12.Subject who had participated in any clinical trials in past 2 months.
- •13.A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.
研究者
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