Status:
COMPLETED
SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 unt...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 3 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00455923
Start Date
May 3 2005
End Date
July 31 2007
Last Update
February 5 2018
Active Locations (1)
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1
GSK Investigational Site
Luleå, Sweden, SE-971 89