CTRI/2024/08/073060已完成Unknown
A Multi-Centric, Active Post Marketing Surveillance Study to Assess the Safety and Efficacy of Fluticasone Furoate and Vilanterol Powder for Inhalation for the Treatment of Patients with Asthma
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 19
- 主要终点
- 1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This will be a multi-centric, active post marketing surveillance to assess the safety and efficacy of Fluticasone Furoate and Vilanterol Powder for Inhalation (200 mcg/ 25 mcg) for the Treatment of Patients with Asthma in adults and adolescents. Approximately, 325 patients will be enrolled in the surveillance from various parts of India. Treatment will be administered for 12 weeks as per treating physician’s discretion based on prescribing information. Surveillance duration of all patients will be 24 weeks and surveillance data on safety and efficacy will be collected for a duration of 24 weeks.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 84.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender, aged between greater than or equal to 12 to lesser than or equal to 84 years
- •Patients with confirmed diagnosis of asthma at least 12 weeks prior to enrollment of the surveillance
- •Patients with asthma where use of a combination medicinal product [long-acting beta2-agonist (LABA) and inhaled corticosteroid (ICS)] is appropriate in opinion of treating physician based on prescribing information (PI) and inadequately controlled on combination of low to medium dose ICS and LABA
- •Patients/Legally acceptable representatives (LAR) are willing to provide informed consent (and assent for patients aged greater than or equal to 12 years and lesser than 18 years) to collect the surveillance data.
排除标准
- •Exclusion of patients from surveillance will be done as per below listed criteria and prescribing information:
- •Patients with history of intolerance or hypersensitivity to any of the components of Fluticasone Furoate and Vilanterol Powder for Inhalation
- •Patient with history of moderate to severe hepatic impairment, cardiac arrhythmias, pulmonary tuberculosis, and ocular disorder (such as cataract, glaucoma etc.)
- •Patient with any clinically significant disorder that, in the opinion of the treating physician would result in jeopardizing patient safety or his/ her inability to understand and comply with the requirements of the surveillance
- •Pregnant women and nursing mothers.
结局指标
主要结局
1. Proportion of patients with Treatment Emergent Adverse Events (TEAEs)
时间窗: Throughout the study period
次要结局
- 1. Change from Baseline in forced expiratory volume in 1 second (FEV1)(Baseline, Weeks 4, 8 and 12)
- 2. Change from Baseline in forced vital capacity (FVC)(Baseline, Weeks 4, 8 and 12)
研究者
Dr Pravin Ghadge
Sun Pharma Laboratories Limited
研究点 (19)
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