A study to evaluate the efficacy and safety profile of inhaled corticosteroid/long acting beta agonist combination among COPD patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Spirometric indices (FEV1,FVC and FEV1/FVC) of COPD patients on Budesonide/formoterol combination versus Fluticasone /salmeterol combination.
研究概览
简要总结
This is a prospective, open randomized parallel group comparative study to evaluate the efficacy and safety profile of Budesonide Formoterol Combination versus Fluticasone Salmeterol Combination in Chronic Obstructive Pulmonary Disease patients. The study will be conducted for a duration of one and half year from date of approval from Ethics Committe of Govt. Medical College, Patiala. The study includes 80 patients, 40 patients in each group (group I and group II) coming to Department of Pulmonary Medicine, Government Tb Hospital attached to Government Medical College, Patiala. Patients from each group (BFC and FSC), diagnosed by GOLD criteria, fulfilling the inclusion criteria and having none of exclusion criteria, will be enrolled in the study after obtaining the written informed consent. In group I, patients will receive Budesonide Formoterol combination (BFC) 200/6 or 400/6 microgm 2 puffs OD. In group II, patients will receive Fluticasone Salmeterol combination (FSC ) 250/50 microgm 2 puffs OD. The therapeutic efficacy of drugs will be evaluated by spirometric indices (FEV1,FVC and FEV1/FVC). Adverse drug reactions will be monitored in patients. Effectiveness of the drugs will be evaluated by change in spirometric indices (FEV1,FVC and FEV1/FVC). All the observations thus made, will be statistically analyzed using appropriate tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Open Label
入排标准
- 年龄范围
- 40.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient age more than 40 years.
- •At least 1 inpatient visit with a primary diagnosis for COPD (Spirometry: post bronchodilator- FEV1/FVC < 0.70).
- •At least 1 ED visit with a COPD diagnosis (either primary or secondary).
- •Patient on inhalational therapy – 2-3 weeks.
排除标准
- •Patient diagnosed with asthma or other non-COPD respiratory disorder.
- •Any previous lung volume reduction surgery AND/OR lung transplantation.
- •3.A requirement for oxygen therapy for at least 12 hours per day.
- •Any exclusionary co-morbid medical condition (cystic fibrosis, bronchiectasis, respiratory cancer, pulmonary fibrosis, pneumoconiosis, sarcoidosis, or any other condition likely to cause death within 3 years.
- •Current use of oral/injectable corticosteroid therapy.
- •Patients (diagnosed with cancer) who received ≥ 180 days of oral corticosteroids (OCS) in the 12-month pre-index period.
- •Patients who initiated both study medications on the same date.
- •Immuno-compromised (HIV +ve) patients.
结局指标
主要结局
Change in Spirometric indices (FEV1,FVC and FEV1/FVC) of COPD patients on Budesonide/formoterol combination versus Fluticasone /salmeterol combination.
时间窗: Baseline and 4 weeks
次要结局
- To monitor the side effects of both Budesonide/formoterol combination and Fluticasone/salmeterol combination.(4 weeks)