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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
Asthma Drug: Seretide Drug: Flixotide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 June 22, 2017