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SERETIDE Vs FLIXOTIDE In Mild Persistent Asthma (GINAII)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00455923
First Posted: April 4, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
April 3, 2007
April 4, 2007
October 12, 2017
May 3, 2005
July 31, 2007   (Final data collection date for primary outcome measure)
Number of participants in each arm with a need for an increase in study medication [ Time Frame: Up to 18 months ]
During the first 6 months, when the asthma was unstable/uncontrolled, dose of Seretide (Sal/FP) was increased from 50/100 mcg in a stepwise fashion to 50/250 mcg and 50/500 mcg (if still unstable). Also, dose of Flixotide (FP only), was increased from 100 mcg to 250 mcg and 500 mcg (if still unstable). After the initial 6 months, the treatment was fixed without further changes. The total treatment period was 18 months. Number of participants in each arm with a need for an increase in study medication are presented.
Number of patients in each arm with a need of an increase of study medication
Complete list of historical versions of study NCT00455923 on ClinicalTrials.gov Archive Site
  • Absolute bronchial hyper-responsiveness up to 18 months [ Time Frame: Up to 18 months ]
    Data for this outcome measure was not collected.
  • Change in bronchial hyper-responsiveness from Baseline to 18 months [ Time Frame: Baseline (Day 0) to 18 months ]
    Data for this outcome measure was not collected.
  • Number of symptom-free days and nights without use of rescue medication [ Time Frame: Up to 18 months ]
    The rescue medications used for exacerbations included Ventoline Diskus® 200 mcg/dose inhalations as required and oral Prednisolone 25 mg per day for five days, and when necessary, ten days. Data for this outcome measure was not collected.
  • Number of exacerbations: in total and by degree of severity [ Time Frame: Up to 18 months ]
    Severe exacerbation: needed hospitalization/emergency unit visit. Moderate exacerbation: Needed oral cortico-steroid or adding inhaled Flixotide to maintenance study medicine; decrease in morning or evening peak expiratory flow (PEF) > 30% during ≥ 2 following days from Baseline (Day 0). Mild exacerbation: any night symptoms ≥ 3 consecutive, or night symptoms ≥ 2 consecutive nights in case symptoms have been scored ≥ 2 during at least one night, Day symptoms scored ≥ 2 during ≥ 4 following days, or Day symptoms scored ≥ 3 during ≥ 3 following days, or Day symptoms scored ≥ 4 during ≥ 2 following days, or rescue medication use ≥ 2 occasions per day for ≥ 4 following days, or rescue medication use ≥ 3 occasions per day for ≥ 3 following days, or rescue medication use ≥ 4 occasions per day for ≥ 2 following days, or decrease in morning/evening PEF >20% during ≥ 2 following days from Baseline (Day 0). Number of total exacerbations and severe, moderate and mild exacerbations are presented.
  • Time to increase of study medication [ Time Frame: Up to 6 months ]
    Data for this outcome measure was not collected.
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
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Asthma
  • Drug: Seretide
  • Drug: Flixotide
    Other Name: Seretide
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 31, 2007
July 31, 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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT00455923
SAM103976
No
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2017

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