A 12 weeks, double blind, prospective, active controlled, comparative; parallel group, multicenter study to assess the efficacy and safety of Fluticasone / Formoterol versus Budesonide / Formoterol combination administered through a pressurized Metered Dose Inhaler (pMDI) in subjects with moderate to severe Bronchial Asthma.

Cipla Ltd Bellasis Road Mumbai Central Mumbai Phone Fax0 个研究点目标入组 236 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 4 期
状态: 已完成
发起方
入组人数: 236

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Subjects willing to give written informed consent.
•2. Subjects of either sex between 18 and 65 years of age.
•3. Confirmed diagnosis of asthma according to GINA guidelines. [Subjects
•demonstrating reversibility (FEV1) of >= 12% & >=200 ml, 20 minutes post
•administration of 200 Î¼g Levosalbutamol delivered by pressurized metered
•dose inhaler (pMDI) with spacer. Documented reversibility within the last 6
•months is acceptable
•4. Subjects with documented history of asthma for at least the past 6 months
•who are on stable dose of ICS or ICS+LABA for at least 4 weeks prior to
•5. FEV1 >= 40% and < 80% of the predicted normal value (as per the European
•Community for Coal and Steel formula and applying the correction factor of
•0.9) when not taking short-acting bronchodilator medication for the previous
•6 hours and ICS+ LABA combination 12 hours prior to screening visit.
•6. Able to use the Peak Flow Meter, pressurized metered dose inhaler (pMDI)
•with zerostat VT spacer and perform the spirometry as per the study
•requirement before entering the run-in period.
•7. In the opinion of the investigator, able to comply with the requirements of
•the protocol.

排除标准

•1.Known or suspected hypersensitivity to combination or any other constituents of the Investigational Medicinal Product (IMP) & study drugs.
•2.Clinical evidence or known history of any serious uncontrolled medical condition [e.g. cardiovascular (high pulse rate, irregular heart beat, high blood pressure), renal, neurological, hepatic, immunological, neoplastic, gastrointestinal, or endocrine disease] or any clinically significant abnormality (e.g. eczema, dermatitis, pneumonia, pulmonary fibrotic disease, active tuberculosis, chronic obstructive pulmonary disease (COPD) or pneumothorax), which, in the opinion of the investigator, might compromise the safety of the subject or which might interfere with the study.
•3.Subjects receiving immunotherapy
•4.Receipt of any herbal medication 30 day prior to the screening visit
•5.Clinically relevant upper respiratory tract infection 4 weeks prior or lower respiratory tract infection 8 weeks prior to the screening visit as judged by investigator.
•6.Females who are pregnant, lactating or planning to become pregnant.
•7.Women of child bearing potential who are unwilling to take adequate contraceptive precautions unless abstinence is considered adequate in the investigator?s opinion.
•8.Clinically significant laboratory values, as judged by the investigator.
•9.Subjects who have previously been randomized into this study.
•10.Receipt of any other clinical trial drug within 30 days prior to study entry (screening visit).
•11.Subjects who are scheduled to receive any other investigational drug during the course of the study.
•12.Hospitalisation due to exacerbation of asthma within the previous 12 weeks preceding study entry (screening visit).
•13.Use of oral or parenteral steroids 4 weeks prior & depot steroid 12 weeks prior to the run-in period.
•14.Current smoker or past smoker with a smoking history of more than or equal to 10 pack years

研究者

发起方

Cipla Ltd Bellasis Road Mumbai Central Mumbai Phone Fax

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