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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
  Purpose

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
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:

MedlinePlus related topics: Asthma
U.S. FDA Resources

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 Names:
    • Seretide
    • Flixotide
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00455923

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

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov 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:
asthma
exacerbation
persistent
 bronchial hyperresponsiveness
mild
GINAII

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Fluticasone, salmeterol drug combination
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics

ClinicalTrials.gov processed this record on May 21, 2013