Text Size

SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00455923
First received: April 3, 2007
Last updated: May 31, 2012
Last verified: January 2012
History of Changes

April 3, 2007
May 31, 2012
May 2005
July 2007   (final data collection date for primary outcome measure)
Number of patients in each arm with a need of an increase of study medication
Same as current
Complete list of historical versions of study NCT00455923 on ClinicalTrials.gov Archive Site
  • 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
Bronchial hyperresponsiveness, number of symptom free days and nights, number of exacerbations, time to first exacerbation, time to increase of study medication
Not Provided
Not Provided
 
SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
  • Drug: Seretide
  • Drug: Flixotide
    Other Names:
    • Seretide
    • Flixotide
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2007
July 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00455923
SAM103976
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP