CTRI/2025/10/096147招募中不适用
Assessment of patient satisfaction ease of training and clinical effectiveness of ICS-LABA combinations delivered through Ciphaler A real world observational study in patients with asthma CONTROL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Cipla Ltd
- 入组人数
- 2,500
- 试验地点
- 3
- 主要终点
- Patient satisfaction
研究概览
简要总结
Drugs administered through the inhaled route have become very important for the treatment of respiratory diseases like asthma. This is a real-world, observational study to assess patient satisfaction, ease of training and clinical effectiveness of ICS-LABA combinations delivered through Ciphaler® in patients with asthma.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Either gender, of age 18 years or above, with documented diagnosis of Asthma (as per GINA 2025) 2 Prescribed treatment with ICS-LABA delivered through the Ciphaler® based on investigator discretion 3 Willing for follow-up at scheduled visit as per protocol 4 A voluntarily given written, signed, dated informed consent from participants and/or legally acceptable representative.
排除标准
- •1 Hypersensitivity to the study drug or any of its components 2 Life-threatening or unstable respiratory disease, including lower respiratory tract infection, within the past 4 weeks from screening 3 Acute episodes of asthma requiring systemic corticosteroids, emergency care or hospitalization in the 30 days prior to Baseline visit 4 Chronic pulmonary diseases other than asthma such as COPD, post-tuberculosis lung disease, pulmonary fibrotic disease, or pulmonary arterial hypertension 5 Severe asthma patients receiving biologicals.
结局指标
主要结局
Patient satisfaction
时间窗: 8 weeks
次要结局
- 1. Ease of training with Ciphaler®
- 2. Change in ACQ-5 score(Baseline)
- 3. Change in ACQ-5 score categories as well controlled (ACQ-5 less than 0.75), partially controlled (ACQ-5 more than 0.75 to less than 1.5), and uncontrolled (ACQ-5 more than 1.5)(Baseline)
- 4. Adverse Event(Through Study)
研究者
Dr Sundeep Salvi
Chest Research and Training Private Limited
研究点 (3)
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