SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Seretide (Drug); Flixotide (Drug)
Phase: Phase 4
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
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
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.
- 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
- 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
- Previous enrollment in the study
Locations and Contacts
GSK Clinical Trials Call Center, Boden-Lulea 971 89, Sweden
Starting date: May 2005
Ending date: March 2006
Last updated: February 28, 2008