Seretide vs Flixotide in mild persistent asthma (GINAII)

GlaxoSmithKline AB0 个研究点目标入组 100 人开始时间: 2005年2月24日最近更新: 2012年3月19日

试验速览

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•Visit 1: Subject who are willing to give written informed consent to participate in the study. 2. Males and females ages 18-70 years. 3. Subjects who are able to understand and complete a DRC. 4. Mild persistent asthma according to GINAII as described under patients and further developed under additional patient criteria (please see protocol). At randomisation: 1. Day symptoms during run-in more than once a week but not every day. 2. Night symptoms not more than once a week. 3. Lungfunction with FEV1=80% of predicited value before or after a broncho-dilation test. 4. A bronchial variability documented by metacholine reactivity PC20=8mg/ml according to the Juniper-Hargreave method or other validated comparable methods.
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Changes to regular asthma treatment in the four weeks prior to visit1. 2. Taken oral, depot or parenteral corticosteroids for the treatment of asthma or any other disease within eight weeks of visit 1. 3. Lower respiartory tract infection within four weeks of visit 1. 4. Received any investigational drugs within four weeks of visit 1.
•5. Smoking history of 10 pack years. 6. Serious uncontrolled disease likely to interfere with the study. 7. Medical conditions or taking medications that are known to affect the assessment or any of the study endpoints. 8. In the opionon of the investigator evidence of alcohol or drug abuse. 9. Known or planned pregnancy. 10. Known or suspected hypersensitivity to inhaled cortico-steroids, ß2-agonist or lactose. 11. Previously been enrolled into this study

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