CTRI/2026/04/107503尚未招募Unknown
Randomized, Open-label, Comparative Study to Evaluate the Efficacy and Safety of Once-Daily Vilanterol / FluticaSone Furoate (Vi/FF) versus TWIce-Daily FormoTerol/Budesonide (For/Bud) MART in Patients with UnControlled AstHma: V-SWITCH study
Glenmark Pharmaceuticals Ltd.6 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年4月15日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 6
研究概览
简要总结
This will be a randomized, open-label, comparative study to evaluate the Efficacy and Safety of Vilanterol/ Fluticasone versus Formoterol/ Budesonide (For/Bud) in Patients with Uncontrolled Asthma. Patients aged greater than equal to 12 years will be enrolled in the study. They would be randomized in a 1 is to 1 ratio to receive either study drug or comparator. Study duration for each subject will be 24 weeks. Physical examination, Vitals, Spirometry, ACQ-5, AE, SAE assessments will be performed at all study visits. Concomitant medications will also be recorded at all visits.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged greater than or equal to 12 years with documented diagnosis of asthma and uncontrolled on low dose of For/Bud (200 µg BD MART).
- •Pre-bronchodilator FEV1 of 40-90% predicted normal.
- •ACQ-5 score greater than or equal to 1.5 at baseline.
- •Patient or parent guardian willing to give a written informed consent/parental consent or assent form.
- •Able to or Willing to strictly adhere to investigator’s prescription.
排除标准
- •Current hospitalization with life threatening condition or patients with acute exacerbation of asthma (acute condition).
- •Patients who have used medium dose Formoterol/Budesonide (6/400 µg DPI) (MART) in the past.
- •Patients already on high dose For/Bud (greater than 800 µg)
- •Patients with COPD
- •Women of childbearing potential are not restricted in this study, however it is expected that the investigator will assess the risks and benefits of the assigned treatment as per the product label(s) and discuss this with any women of childbearing potential prior to providing the patient with the prescription for the assigned treatment.
- •Patients who have participated in any clinical trial within 30 days prior to enrolment and would not be participating in clinical study during the period of study participation
- •History of known hypersensitivity to any individual study drug of the study drug combination or to any of the excipient present in the dosage form.
研究者
Dr Sumit Bhushan
Glenmark Pharmaceuticals ltd.
研究点 (6)
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