A study to evaluate the real world effectiveness of Inhaled corticosteroid/Long acting beta agonist combination and assessment of Health related quality of life among COPD patients on this therapy
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
- Comparison in exacerbation rate and SGRQ score in patients of COPD on Budesonide/Formoterol combination versus Fluticasone/Salmeterol combination.
研究概览
简要总结
A prospective, open-label, randomized parallel group comparative study to evaluate the real-world effectiveness of Inhaled Corticosteroid/Long Acting Beta Agonist combination and assess the Health-related Quality of life, in Chronic Obstructive Pulmonary Disease patients.
The study is to be conducted for a duration of one year from the date of approval of plan of thesis from Ethics Committee of BFUHS, Faridkot and Government Medical College, Patiala. It includes total of 80 patients, 40 patients in group I and 40 patients in group II. Patients coming to the Dept. of Pulmonary Medicine, Government TB Hospital, Patiala (GMC, Patiala) 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. Study samples will be balanced on age, gender, and pre-index characteristics including COPD-related inpatient hospitalizations and Emergency Department visits.
In group I, patients will receive inhaled Budesonide/Formoterol combination (BFC- 200/6 microgram or 400/6 microgram) 1-2 puff OD. In group II, patients will receive inhaled Fluticasone/Salmeterol combination (FSC - 250/50 microgram) 1-2 puff OD. The effectiveness of drugs will be evaluated by observing change in exacerbation rate. Adverse drug reactions will be monitored in patients. Health related quality of life will be evaluated by administering St. George’s Respiratory Questionnaire (SGRQ). Effectiveness of the drugs will be calculated in terms of improvement in breathlessness Modified Medical Research Council (mMRC) scale.
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
- •Male and female patients of age 40 years or more.
- •Patient with at least 1 Inpatient Department visit with primary diagnosis for COPD (Spirometry: post bronchodilator- FEV1/FVC < 0.70).
- •Patient with at least 1 Emergency Department visit with COPD diagnosis.
- •Patient not having an exacerbation for one month prior to study entry.
- •Patient on inhalational therapy for 2-3 weeks.
排除标准
- •Patient diagnosed with asthma or other non-COPD respiratory disorder.
- •Patient with history of any previous lung volume reduction surgery and/or lung transplantation.
- •Patient who requires 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.
- •Immuno-compromised (HIV +ve) patients
- •Patients who are not willing to give written informed consent.
结局指标
主要结局
Comparison in exacerbation rate and SGRQ score in patients of COPD on Budesonide/Formoterol combination versus Fluticasone/Salmeterol combination.
时间窗: 2 week and 4 weeks
次要结局
- To manage the side effects of both Budesonide/Formoterol combination and Fluticasone/Salmeterol combination in COPD patients.(2 week and 4 weeks)