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SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)

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

Condition Intervention Phase
Drug: Seretide
Drug: Flixotide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: SERETIDE vs FLIXOTIDE in Mild Persistent Asthma (GINAII)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of patients in each arm with a need of an increase of study medication

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 100
Study Start Date: May 2005
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Seretide Drug: Flixotide
    Other Name: Seretide

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00455923

GSK Investigational Site
Luleå, Sweden, SE-971 89
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00455923     History of Changes
Other Study ID Numbers: SAM103976 
Study First Received: April 3, 2007
Last Updated: May 31, 2012
Health Authority: Sweden: Medical Products Agency

Keywords provided by GlaxoSmithKline:
bronchial hyperresponsiveness

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics processed this record on October 25, 2016