CTRI/2018/09/015862暂停不适用
An open-label, multicenter, randomized, comparative study to evaluate efficacy and safety of Respiforb® inhalation powder, pre-dispensed 320+9 μg/dose (Sava Healthcare Limited, India) and Symbicort® Turbuhaler®, inhalation powder, pre-dispensed 320+9 μg/dose (AstraZeneca AB, Sweden) in patients with partly controlled asthma’
PSK Pharma LLC2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2018年2月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in FEV1
研究概览
简要总结
The planned study is an open-label, multicenter, randomized, comparative study to evaluate efficacy and safety of Respiforb®, inhalation powder, pre-dispensed 320+9 μg/dose (Sava Healthcare Limited, India) and Symbicort® Turbuhaler®, inhalation powder, pre-dispensed 320+9 μg/dose (AstraZeneca AB, Sweden) in patients with partly controlled asthma.
Total duration of the study for each patient will not exceed 102 days
The 1st group of patients will receive Respiforb® – 1 inhalation (320+9 mcg/dose) twice daily for not more than 88 days (up to Visit 4 inclusive).
The 2nd group of patients will receive Symbicort® Turbuhaler® – 1 inhalation (320+9 mcg/dose) twice daily for not more than 88 days (up to Visit 4 inclusive).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Availability of a signed copy of the Informed Consent Form of the Patient Information Leaflet.
- •Male and female patients 18 to 70 years of age (inclusive) at the moment of signing the Informed Consent Forms (ICF).
- •Diagnosis of persistent asthma established according to the GINA guidelines (2017) not less than 6 months prior to the screening visit.
- •Asthma that is inadequately controlled by inhaled corticosteroids (ICS) inhaled corticosteroids and short-acting beta-agonists (SABA) as on-demand therapy.
- •Need to use bronchodilatory therapy with a combination of ICS and long-acting beta agonists (LABA).
- •ACQ-5 score ≥0.75 and <1.5.
排除标准
- •Patients who need the selection of initial maintenance therapy for asthma.
- •Contraindications for use of ICS, hypersensitivity to budesonide, formoterol, salbutamol, inhaled lactose or to any other component of the study drugs.
- •Lactose intolerance, lactase deficiency, or glucose.
- •galactose malabsorption.
- •A diagnosis of chronic obstructive pulmonary disease (COPD) established according to the 2017 version of the GOLD guidelines.
- •Excessive requirement of SABA
- •Use of oral or parenteral corticosteroids within 2 months prior to the screening visit (3 months for extended-release parenteral ICS).
- •The use of immunosuppressive agents (e.g., cyclosporine, methotrexate, tumor necrosis factor (TNF) inhibitors or anti-TNF-antibodies, gold salts, azathioprine) within 4 weeks prior to the screening visit.
- •Conditions that require the use of systemic therapy with corticosteroids at the time of the screening visit.
- •Unexpected progressive deterioration of asthma symptom control.
- •A history of a nearly fatal asthma attack (e.g., unstable asthma, hospitalization due to asthma exacerbation to ICU with the use of intubation).
- •Pulmonary tuberculosis (active or inactive form).
- •Fungal, viral, or bacterial respiratory tract infections, or systemic viral infection, Herpes simplex-related eye disease at the moment of the screening visit.
- •Lower respiratory tract infection within 1 month prior to the screening visit.
- •Cystic fibrosis, bronchiectasis, pneumoconiosis.
- •Restrictive ventilatory defects.
- •Uncontrolled hypokalemia, hypocalcaemia.
- •Thyrotoxicosis.
- •Osteoporosis.
- •Glaucoma, cataract.
结局指标
主要结局
Change in FEV1
时间窗: At Visits 1 and 4
次要结局
- FEV1 changes(assessed 2 hours after inhalation of the test drug/reference drug.)
- PEF changes(by Visits 2, 3, and 4.)
- ACQ-5 score(changes over time.)
- Percentage of patients who developed exacerbation(by Visits 2, 3, and 4.)
- SF-36 (quality of life questionnaire) score(changes over time.)
- Percentage of patients achieving asthma control(by Visit 4.)
- Weekly average daily SABA requirement (salbutamol)(at Week 1, 4, 8, and 12.)
研究者
研究点 (2)
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