Double blind, double dummy, randomized, two way cross-over study to compare the effects of Seretide® Evohaler (supplied by Allen & Hanburys, UK) and a generic test HFA pMDI (manufactured by Cipla Ltd, India) on functional respiratory imaging parameters in asthmatic patients.

FluidDA nv0 个研究点开始时间: 2013年1月29日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•1. Male or female patient = 18 years old
•2. Written informed consent obtained
•3. Patient with a documented diagnosis of asthma according to the Global Initiative for Asthma (GINA) guidelines
•4. Patient with a co-operative attitude and ability to be trained to correctly use the Seretide® and Cipla Seretide generic MDI
•5. Female patient of childbearing potential who confirm that a contraception method was used at least 14 days before visit 1 and will continue to use a contraception method during the study
•6. Patient must be stable and treated in accordance with the GINA guidelines
•7. Patient must be a non-smoker or ex-smoker who have stopped smoking at least 1 year prior to the visit 1 and has a smoking history of < 10 pack years
•8. Patient must be able to understand and complete the protocol requirements, instructions, questionnaires and protocol-stated restrictions
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 8
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•1. Pregnant or lactating female
•2. Unstable patient who developed an exacerbation during the last 8 weeks
•3. Patient with upper or lower airways infection
•4. Patient unable to carry out pulmonary function testing
•5. Patient with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study
•6. Patient with cancer or any other chronic disease with poor prognosis and /or affecting patient status
•7. Patient with allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients
•8. Patient unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study
•9. Patient who received oral corticosteroids within the last 4 weeks prior to visit 1
•10. Patient who received any investigational new drug within the last 4 weeks prior to visit 1 or twice the duration of the biological effect of any drug (whichever is longer).
•11. Patient with a history of alcohol or substance abuse that in the opinion of the investigator may be of clinical significance
•12. Patient who has undergone major surgery in the last 12 weeks before the visit 1 or has planned to undergo a major surgery before the end of the trial
•13. Patient with diagnosis of COPD

发起方

FluidDA nv