SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)

Condition(s) targeted: Asthma

Intervention: Seretide (Drug); Flixotide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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.

Official title: SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII)

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Number of patients in each arm with a need of an increase of study medication

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

GSK Clinical Trials Call Center, Boden-Lulea 971 89, Sweden

Starting date: May 2005
Ending date: March 2006
Last updated: February 28, 2008