Seretide vs Flixotide in mild persistent asthma (GINAII)

Conditions: Mild persistent asthma(fulfilling the criteria for asthma of severity grade GINAII) requiring daily maintenance treatment

Registration Number: EUCTR2005-000836-25-SE

Lead Sponsor: GlaxoSmithKline AB

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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