CTRI/2009/091/000111已完成3 期
An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination of Formoterol fumarate & Mometasone furoate Dry Powder Inhaler DPI and fixed-dose combination of Formoterol fumarate & Budesonide Dry Powder Inhaler (DPI) for the treatment of bronchial asthma and or COPD.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 5
- 主要终点
- The degree of improvement in PEFR at each visit and at the end of the study as compared to baseline
研究概览
简要总结
This study is an open label, comparative, multicentric study comparing the safety and efficacy of fixed-dose combination of Formoterol fumarate & Mometasone furoate Dry Powder Inhaler (DPI) and fixed-dose combination of Formoterol fumarate & Budesonide Dry Powder Inhaler (DPI) two respicaps twice daily each in 200 patients with bronchial asthma and/or chronic obstructive pulmonary disease (COPD) that will be conducted in India. The primary outcome measures will be degree of improvement in PEFR at each visit and at the end of the study as compared to baseline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients between 18-65 years of age 2.Patients with an established diagnosis of bronchial asthma and/or chronic obstructive pulmonary disease (COPD) requiring a combination of long acting beta 2-agonists and inhalation corticosteroids 3.Informed consent of the patient/relative.
排除标准
- •1.Pregnancy and/or lactation2.Patients with severe or recently unstable bronchial asthma or status asthmaticus3.Patients requiring nebulized therapy or oral corticosteroids4.Patients with active or quiescent tuberculosis infection, glaucoma, untreated systemic fungal, bacterial, viral or parasitic infections or ocular herpes simplex5.Patients with a clinically relevant respiratory tract infection in the four weeks prior to enrolment6.Patients with any significant disease of any other organ system (renal, hepatic, cardiovascular, neurologic etc.) that could interfere with the study or require treatment which might interfere with the study7.Patients with history of known hypersensitivity to formoterol fumarate or mometasone furoate or budesonide or salbutamol or any component of the formulations8.Patients with any other serious concurrent illness or malignancy9.Patients with continuing history of alcohol and/or drug abuse10.Participation in another clinical trial in the past 3 months.
结局指标
主要结局
The degree of improvement in PEFR at each visit and at the end of the study as compared to baseline
时间窗: 1-4 weeks
次要结局
- The degree of improvement in the day-time and the night-time asthma symptoms (cough, wheeze, chest tightness, and shortness of breath) score as assessed on a 4-point scale as mentioned above at each visit and at the end of the study as compared to baseline(1-4 weeks)
研究者
研究点 (5)
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