CTRI/2025/03/083342招募中4 期
A Phase IV study to evaluate safety and efficacy of FDC of Indacaterol 150 mcg + Glycopyrronium 50 mcg + Mometasone Furoate IP 160 mcg powder for inhalation in patients with Asthma
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Cipla Ltd
- 入组人数
- 164
- 试验地点
- 11
- 主要终点
- Adverse events including Serious adverse events (SAEs) and Treatment emergent adverse events (TEAE).
研究概览
简要总结
All patients willing to participate in the study will be required to give a written informed consent in the language understood by him/her. Patients will require a confirmed documented diagnosis of Asthma through spirometry.Patients not adequately controlled with a maintenance combination of long-acting beta 2 agonist and a high dose of an inhaled corticosteroid with history of one or more asthma exacerbations in last one year will be enrolled. Assessments of safety (adverse events), Spirometry (trough FEV1), asthma control questionnaire and quality of life, will be conducted at screening, baseline, week 6 and week 12
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients Greater than 18 years of age with a diagnosis of asthma, GINA 2024 for a period of at least 1 year prior to Screening.
- •Patients not adequately controlled with a maintenance combination of long acting beta 2 agonist and a high dose of an inhaled corticosteroid.
- •[High dose of ICS: Beclomethasone greater than 400mcg, Budesonide greater than 800mcg, fluticasone furoate greater than 200mcg, fluticasone propionate greater than 500mcg, mometasone furoate greater than 400mcg].
- •Patient should be on high dose of ICS for at least one month prior to screening.
- •ACQ-5 score greater than or equal to 1.5 at screening.
- •History of one or more asthma exacerbations in last one year.
- •Patients with pre-bronchodilator FEV1 less than 80% of the predicted normal value at screening.
- •An increase in FEV1 of greater than or equal to 12% and 200 mL within 15 to 30 minutes after administration of 400 mcg salbutamol or 200mcg of levosalbutamol.
排除标准
- •Patients with acute exacerbation of asthma (acute condition) within past 3 months.
- •Patients who smoked or inhaled tobacco products within 6 months prior to screening or who had a smoking history of greater than 10 pack-years.
- •Received treatment with Triple therapy i.e. ICS/LABA/LAMA within past 6 months.
- •Patients with history of uncontrolled diabetes and/or uncontrolled glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention.
- •Patients with a history of myocardial infarction (confirmed clinically by the investigator) within the previous 12 months.
- •Patients who have had a respiratory tract infection or asthma worsening.
结局指标
主要结局
Adverse events including Serious adverse events (SAEs) and Treatment emergent adverse events (TEAE).
时间窗: Baseline | Week 6 | week 12
次要结局
- Proportion of patients achieving a minimal clinically important difference (MCID) of a 0.5 units reduction in ACQ-5 from baseline at week 6 & week 12.(Week 6)
- Mean change in trough FEV1 at week 6 & week 12 from baseline(Week 6)
- Mean change in pre-dose morning & evening PEFR at week 6 & 12 from baseline(week 6)
- Mean change in Mini AQLQ at week 12 from baseline.(Week 12)
- Percentage of days without rescue medication usage(Week 12)
- Mean change in ACQ-5 score at week 6 & 12 from baseline.(Week 6)
- Proportion of patients with uncontrolled, partly controlled & well controlled asthma as per ACQ-5 at week 6 & week 12(Week 6)
- Proportion of patients achieving a MCID of 0.5 units increase in Mini AQLQ from baseline at week 6 & week 12.(Week 6)
研究者
研究点 (11)
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