NCT05322707已完成3 期
Multicenter Randomized Parallel-Group 6-Week Treatment Clinical Study to Assess BE of Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg Inhalation Product in Comparison With Reference Product, Symbicort® in Adult Asthma Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Cipla Ltd.
- 入组人数
- 1,485
- 试验地点
- 1
- 主要终点
- Change in FEV1 from baseline
研究概览
简要总结
The purpose of the study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in adult patient with Asthma
详细描述
This study is to demonstrate the Pharmacodynamic bioequivalence of the test product to the reference product in terms of FEV1 measures at different timepoints in adult patient with Asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients who are 18-70 years of age
- •Has moderate-to-severe asthma with a pre-bronchodilator FEV1 of ≥45% and <80% of the predicted normal value for the patient after withholding bronchodilators
- •Has ≥15% and ≥0.20 L reversibility of FEV1 within 30 minutes following administration of 360 μg of albuterol (pMDI)
- •Is stable on current chronic asthma treatment (documented asthma diagnosis and/or prescription for asthma medications) for at least 4 weeks prior to screening visit (Visit 1).
- •Has been diagnosed with asthma as defined by the National Asthma Education and Prevention Program (NAEPP 2007) at least 6 months prior to screening
- •Adult male or female patients of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control
排除标准
- •Has history of life-threatening asthma defined as an asthma episode(s) that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures, asthma related syncopal episode(s), within past 1 year or during run-in period
- •Has history of any asthma-related hospitalizations within the past one year prior to screening visit (Visit 1) or during the run-in period
- •Has history of any pulmonary disorder other than asthma, including but not limited to: diagnosis of chronic obstructive pulmonary disease (COPD), interstitial lung disease, cystic fibrosis, bronchiectasis, chronic bronchitis, pulmonary hypertension, active pulmonary tuberculosis, or pulmonary carcinoma.
- •Has current evidence of bronchopulmonary dysplasia or pulmonary fibrosis
- •Has recent respiratory tract infection that is not resolved within 4 weeks of screening and is considered significant in the opinion of the investigator
- •Patients who, in the opinion of the investigator, significantly abuse alcohol or drugs, will be excluded.
- •Is taking any immunosuppressive medications within 4 weeks prior to the screening and during the study
- •Use of systemic or oral corticosteroids within 2 months or intramuscular depot corticosteroid treatment 90 days prior to the screening or during the run-in period for any reason other than asthma.
- •Women of childbearing potential who are lactating or pregnant at screening visit, as documented by a positive screening pregnancy test.
- •Has previously been randomized in this study
研究组 & 干预措施
Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg
Experimental
Inhalation Aerosol, 2 actuations orally inhaled twice daily
干预措施: Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg (Drug)
Symbicort®
Active Comparator
Inhalation Aerosol, 2 actuations orally inhaled twice daily
干预措施: Symbicort, 80 Mcg-4.5 Mcg/Inh Inhalation Aerosol (Drug)
Placebo for Budesonide 80 μg and Formoterol Fumarate Dihydrate 4.5 μg
Placebo Comparator
Inhalation Aerosol, 2 actuations orally inhaled twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in FEV1 from baseline
时间窗: 6 weeks treatment
FEV1 measured in the morning prior to the dosing of inhaled medication on the last day of the 6 weeks treatment
Area under the serial Force Expiration volume1
时间窗: From time 0 to 12 hours
Area under the serial Force Expiration volume1 from time 0 to 12 hours (AUC0-12 hours) on the first day of the treatment
次要结局
- Number and Severity of Adverse Events and Serious Adverse Events(6 weeks treatment)
- Number of participants with suspected oral infection performed with an oropharyngeal examination(6 weeks treatment)
- Assessment of vital signs: Pulse rate(6 weeks treatment)
- Assessment of vital signs: Systolic and diastolic Blood Pressures(6 weeks treatment)
研究者
研究点 (1)
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