CTRI/2022/02/040421已完成不适用
Pharmacodynamic Bioequivalence of two formulations of Ipratropium Bromide (21 mcg) HFA in Subjects with Chronic Obstructive Pulmonary Disease: A Randomized, Observer-Blind, Three Treatment, Three Period, Six Sequence, Single Dose, Crossover, Placebo and Active Controlled Comparative Study
Sun Pharmaceutical Industries Ltd SPIL18 个研究点 分布在 1 个国家目标入组 114 人开始时间: 2022年2月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 18
- 主要终点
- Area under the serial FEV1-time curve calculated from time zero to 6 hours (AUC0-6h) following the treatment
研究概览
简要总结
· The purpose/objective of the study is todemonstrate the Pharmacodynamic equivalence of the Test formulation ofIpratropium Bromide 21 mcg Hydrofluoroalkane (HFA) of SPIL, India and Atrovent®21 mcg HFA of Boehringer Ingelheim Pharmaceuticals, Inc. in Subjects with COPD.We will share the findings once the study is complete. There are no associatedpublications for the test product. The reference product, Atrovent, is anapproved and marketed product. The USFDA assessment can be accessed using thebelow link
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=BasicSearch.process
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Men or non-pregnant and non-lactating women aged greater than or equal to 40 years.
- •2.Diagnosis of COPD as defined by American Thoracic Society (ATS)-Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines, 2021 (patient with dyspnea, chronic cough or sputum production, and/or history of exposure to risk factors for the disease).
- •3.Post-bronchodilator FEV1 less than or equal to 65% of predicted [criterion evaluated 24 to 72 hours prior to dosing in Period 1].
- •4.Post-bronchodilator FEV1/FVC ratio less than or equal to 0.70 [criterion evaluated 24 to 72 hours prior to dosing in Period 1].
- •5.Able to successfully complete placebo run-in after withholding restricted medications and able to withhold restricted medications for specified duration prior to dosing.
- •6.Current or former smoker with smoking history of greater than or equal to 10 pack-years.
- •7.Able to satisfactorily administer the medication and perform pulmonary function test.
- •8.Willing and able to give written informed consent.9.Subjects of childbearing potential must practice an acceptable method of birth control as judged by the Investigator.
排除标准
- •1.Subjects with evidence or history of significant disease or abnormality other than COPD (such as congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infraction, stroke, glaucoma, or cardiac dysrhythmia).
- •A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study, or a disease which may influence the results of the study, or the subject’s ability to participate in the study.
- •2.Known respiratory disorder other than COPD, including but not limited to the following: alpha-1 antitrypsin deficiency, cystic fibrosis, active bronchiectasis, significant asthma, sarcoidosis, lung fibrosis, pulmonary hypertension, or interstitial lung disease.
- •3.History of allergy or hypersensitivity to anticholinergic/ muscarinic receptor antagonist agent, beta-2 agonists, or specific intolerance to aerosolized ipratropium bromide-containing products, or known hypersensitivity to any of the non-medicinal ingredients [citric acid, ethanol, propellant HFA 134a (1,1,1,2-tetrafluorethane), nitrogen].
- •4.History of asthma, allergic rhinitis, or atopy, a blood eosinophil count >6%.
- •5.Known active tuberculosis based on chest X-ray, physical examination and medical judgment of the investigator.
- •6.History of having undergone thoracotomy with pulmonary resection.
- •Subjects with a history or a thoracotomy for other reasons will be evaluated per exclusion criterion No.
- •8.History of narrow angle glaucoma, prostatic hypertrophy, or bladder neck obstruction, which, in the investigator’s opinion, would contraindicate the use of an anticholinergic agent.
- •9.Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 6 weeks prior to initiation of the study (screening visit).
- •10.Abnormal and significant electrocardiogram (ECG) finding prior to screening, during the run-in and treatment periods.
- •11.Treatment for COPD exacerbation within 12 weeks prior to initiation of the study (screening visit).
- •12.Hospitalization for COPD or pneumonia within 12 weeks prior to initiation of the study (screening visit).
- •13.Inability to discontinue COPD medications during the run-in and treatment periods.
- •14.Lung volume reduction surgery within 12 months prior to initiation of the study (screening visit).
- •15.Chronic oxygen use for >12 hours/ day.
结局指标
主要结局
Area under the serial FEV1-time curve calculated from time zero to 6 hours (AUC0-6h) following the treatment
时间窗: Serial spirometry (FEV1) will be measured at 0, 10, 15, 30, 60, 90, and 120 minutes, and 3, 4, 5, and 6 hours post-dose.
次要结局
- Time to peak bronchodilator response (Tmax); FEV1 values at all measurement times within each period(Tmax or time to peak bronchodilator response will be assessed post dosing in each period. The time points for FEV1 measurement will serve as time points for “time measurementâ€)
研究者
研究点 (18)
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