SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)

• Status: Completed
• Trial end date: 2007-07-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination

Criteria

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