CTRI/2025/02/080495已完成3 期
A prospective, randomized, double-blind, parallel, active-controlled, multicentre, phase III clinical trial to assess the efficacy and safety of Vilanterol, Umeclidinium and Fluticasone furoate inhalation as compared to Vilanterol and Fluticasone furoate inhalation in patients with uncontrolled asthma.
Zydus Healthcare Limited,10 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2025年2月24日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 376
- 试验地点
- 10
- 主要终点
- Change from baseline in trough FEV1 at the end of the study
研究概览
简要总结
In this study, the efficacy and safety of our investigational triple drug FDC of VI/UMEC/FF MDI (Test drug) will be evaluated and compared with FDC of VI/FF MDI (Reference drug) in the patients with asthma who are inadequately controlled on medium-to-high dose ICS/LABA. This will help in evaluating the efficacy & safety of addition of a LAMA, Umeclidinium in patients who are already receiving ICS/LABA combination therapy for management of asthma. Both the dose strengths of the reference drug have already been approved by the Central Licensing Authority for the management of asthma. Clinical trial duration of up to 12 weeks (~3 months) is considered appropriate to demonstrate the long-term efficacy and safety of FDC of ICS/LABA/LAMA; therefore, 12 weeks treatment duration is proposed in this study. As per the recommended dosage, both the study drugs are intended for once daily (OD) dosing. Enrolled patients will be instructed to administer 2 actuations of the allocated study drug in morning. This will be a double-blind study and MDIs containing either the test drug or the reference drug will have identical physical characteristics and will be indistinguishable from each other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender between 18-65 years of age (both inclusive).
- •Patients diagnosed with asthma for at least 12 months prior to screening.
- •Pre-bronchodilator FEV1 of 30% to 80% of the predicted normal value at screening.
- •Patients with bronchodilator reversibility i.e., increase in FEV1 of more than 12% and more than 200 ml after salbutamol inhalation at screening.
- •Patients receiving ICS/LABA combination for asthma for at least 3 months with stable dose of medium or high dose of ICS/LABA combination for more than 6 weeks prior to screening.
- •Patients who are symptomatic at screening defined as Asthma Control Test (ACT) score less than equal to
- •Patients with a history of at least one severe asthma exacerbation within past 12 months prior to screening.
- •Patients willing to provide written informed consent and comply with the protocol requirements.
- •Patients literate enough to fill the diary card.
排除标准
- •Known hypersensitivity to any beta2 agonist, sympathomimetic drug, anti-muscarinic agent or any inhaled, intranasal or systemic corticosteroid 2)History of life-threatening asthma within past 5 years prior to screening.
- •Asthma exacerbation requiring systemic corticosteroids or that resulted in hospitalization or emergency room visit within 6 weeks prior to screening 4)Patients treated with a long acting muscarinic antagonist within 3 months prior to screening 5)Patients with known diagnosis of narrow angle glaucoma, prostatic hyperplasia, bladder neck obstruction or urinary retention 6)Suspected or confirmed bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear within 4 weeks prior to screening.
- •Patients with concurrent respiratory disorder other than asthma such as but not limited to pneumonia, pulmonary tuberculosis, chronic bronchitis, chronic obstructive pulmonary disease, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pneumothorax, atelectasis, bronchopulmonary dysplasia, interstitial lung disease, cystic fibrosis 8)Clinical evidence of oropharyngeal candidiasis at screening 9)Patients with clinically significant uncontrolled systemic diseases such as cardiovascular, renal, neurological, psychiatric, endocrine, immunological or hematological disorders or malignancy 10)Patients with hepatic dysfunction (serum transaminases greater than equal to 3 x Upper Normal Limit) or renal dysfunction (blood bilirubin or serum creatinine greater than equal to 1.5 x Upper Normal Limit) at screening 11)Patients who have used prohibited medications 12)Pregnant or Lactating females; or female patients of childbearing potential unwilling to use effective contraception 13)Current smokers or ex-smokers who have stopped smoking within 6 months prior to screening or have a smoking history of at least 10 pack-years 14)Patients with continuing history of alcohol and/or drug abuse 15)Participation in another clinical trial within 3 months prior to screening 16)Any other reason for which the investigator feels that the patient should not participate.
结局指标
主要结局
Change from baseline in trough FEV1 at the end of the study
时间窗: Baseline to end of study
次要结局
- Change from baseline in trough FEV1 at week 4(Baseline to week 4)
- Change from baseline in trough FVC(Baseline , week 4 and end of study)
- Change from baseline in post-bronchodilator FEV1 and FVC(Baseline , week 4 and end of study)
- Change from baseline in the ACT score(Baseline to week 4, week 8 and end of study)
- Use of rescue medication during the treatment period(Day 0 to end of study)
- Asthma exacerbations reported during the study(Day 0 to end of study)
- Global impression of change in the disease condition by the patients(end of study)
- Global assessment of efficacy by the investigator(End of study)
研究者
Dr Deven V Parmar
Zydus Research Centre
研究点 (10)
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