CTRI/2019/01/017005尚未招募不适用
A multicentre, open label study to assess device functionality by in-vitro performance after repeated use of Albuterol Sulfate Inhalation Aerosol 90 mcg (with dose indicator) manufactured by Cipla Ltd. (India) in asthma and chronic obstructive pulmonary disease (COPD) subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Cipla Ltd
- 入组人数
- 75
- 试验地点
- 7
- 主要终点
- This study has the following primary objective: • To assess the device functionality (via pharmaceutical performance) after repeated use of Albuterol Sulfate Inhalation Aerosol 90 mcg (with dose indicator) manufactured by Cipla Ltd. (India) by asthma and COPD subjects.
研究概览
简要总结
This is a device performance study, to assess the in:vitro performance of the device after the patient uses the device repeatedly over the period of time. there are no safety or efficacy assessments performed in the study. The used devices by the patients will be collected back and send to central testing laboratory for in vitro analysis. key parameters such as delivered dose uniformity and Aerodynamic Particle Sized Diameter will be determined. This data will help to assess whether there is any impact on the device performance after repeated use by patients in clinical setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female subjects who are ≥ 18 years of age at the time when informed consent is obtained.
- •Subjects diagnosed with asthma or COPD by the investigator in accordance to relevant guidelines i.e. GINA guidelines for Asthma diagnosis and management and GOLD guidelines for COPD diagnosis and management
- •Subjects on treatment of Asthma or COPD requiring albuterol.
- •Women of child bearing potential (WOCBP) must commit to be consistent and for correct use of an acceptable method of birth control (acceptable method will be at the investigator’s discretion) throughout the study
- •Subjects who are able to use pMDI effectively as per the standardized inhalation technique.
排除标准
- •History of life-threatening asthma/COPD that required intubation and/or was associated with hypercapnoea, respiratory arrest, or hypoxic seizures, asthma/COPD related syncopal episode(s) within the past one year prior to enrolment visit.
- •History of any asthma or COPD-related hospitalizations within the past one year prior to enrolment visit.
- •Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension (systolic BP ≥160 mm Hg or diastolic BP >100 mm Hg), uncontrolled coronary artery disease, myocardial infarction, Stroke within 3 months prior to the enrolment visit, or cardiac dysrhythmia.
- •In addition, historical or current evidence of significant hematologic, hepatic neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbated during the study
- •Intercurrent disease or condition that, in the opinion of the Investigator, might compromise the subject’s continued safety or eligibility for the study
- •History of any adverse reaction; known hypersensitivity to any sympathomimetic drug (e.g., formoterol or albuterol) or any inhaled, or therapy or any other constituents of the investigational product
- •Factors (e.g., infirmity, disability, geographic location) that the investigator felt would likely limit the subjects’ compliance with the study protocol or scheduled clinic visits
- •Women of childbearing potential (WOCBP) who are lactating or pregnant atenrolment visit, as documented by a positive screening pregnancy test (see schedule of study events).
- •For this study, WOCBP is defined as females following menarche until becoming postmenopausal or undergoing permanent sterilization.
- •Postmenopausal is defined as no menses for 12 months without an alternative medical cause.
- •Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy
- •Study participation by clinical investigator site employees and/or their immediate relatives
- •Subjects unable to use pMDI device with or without spacer or comply with the study regimen.
结局指标
主要结局
This study has the following primary objective: • To assess the device functionality (via pharmaceutical performance) after repeated use of Albuterol Sulfate Inhalation Aerosol 90 mcg (with dose indicator) manufactured by Cipla Ltd. (India) by asthma and COPD subjects.
时间窗: visit 4 day 40
次要结局
- To assess the safety and tolerability of Albuterol Sulfate Inhalation Aerosol 90 mcg (with dose indicator) manufactured by Cipla Ltd. (India).(visit 4 day 40)
研究者
研究点 (7)
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