Official Title: “SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII)”

An 18 months randomised double-blind study with two parallel arms with start dose of inhaled SERETIDE 50/100mcg BD or FLIXOTIDE 100mcg BD, Phase I is 6 months where the patient will be up-titrated until well controlled is achieved, After 6 months the treatment continues without changes during 9 months = PhaseII. The aim is to investigate and evaluate the assumption that the combination therapy with SERETIDE controls mild persistent asthma better than inhaled corticosteroids(FLIXOTIDE) alone.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2007

Intervention(s) in this Clinical Trial

• Drug: Seretide
• Drug: Flixotide

Primary Measures

• Number of patients in each arm with a need of an increase of study medication

Secondary Measures

• Bronchial hyperresponsiveness, number of symptom free days and nights, number of exacerbations, time to first exacerbation, time to increase of study medication
• 1. Bronchial hyper-responsiveness both change from baseline and change in values at the end of the study.
• 2. Number of symptom-free days and nights without use of rescue medication.
• 3. Number of exacerbations. 4. Time to first exacerbation. 5. Time to increase of study medication

Inclusion Criteria:

• Willing to give informed consent.
• Males or females aged 18-70.
• Able to understand and complete dairy cards.
• Mild persistent asthma according to GINA. In addition, at randomisation subjects were required to have:
• 1. Day time symptoms more than once a week but not every day. 2. Night-time symptoms not more than once a week. 3. FEV1 >80% predicted 4.
• PC20 <8mg/mL

Exclusion Criteria:

• Change to regular asthma medication in 4-weeks prior to visit 1.
• Use of oral, depot or parenteral corticosteroids within 8 weeks of visit 1.
• Lower respiratory tract within 4 weeks of Visit 1
• Received investigational study drug within 4 weeks of visit
• Smoking history of >10 pack years of more.
• Serious uncontrolled disease.
• Medical conditions or medications known to affect the assessments or endpoints.
• Evidence of alcohol or drug abuse.
• Known pregnancy or planned pregnancy.
• Known or suspected hypersensitivity to inhaled corticosteroids, beta-agonists or lactose.
• Previous enrollment in the study

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00455923

Study ID Number: SAM103976

ClinicalTrials.gov Identifier: NCT00455923

Health Authority: Sweden: Medical Products Agency