Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data
NCT ID: NCT00363480
Last Updated: 2018-03-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
221 participants
INTERVENTIONAL
2006-05-17
2007-09-14
Brief Summary
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The aim of the study is to show that most of symptomatic asthma patients can reach 'well controlled asthma' with SFC. We get information about ACT in daily practice and physicians are trained to use the asthma control test as a screening tool and for follow up of asthma management. Correlations are expected between the improvements in ACT, Quality of Life and asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SFC 50/250 mcg
Participants received the combination product, fluticasone 250 microgram (mcg) plus salmeterol 50 mcg (SFC 50/250 mcg) for 12 weeks. Study treatment was received using DISKUS™ powder inhalers, one dose in morning and evening. Study medication was dispensed at visits 3, 4, and 5 for 30 days each. The participants were provided with salbutamol rescue medication if they developed acute asthmatic symptoms. This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol. Use of rescue medications was recorded in the participant's asthma diaries. Stable dosages of other concomitant medications were allowed if they had no impact on the outcome criteria.
Salmeterol/Fluticasone 50/250 mcg
Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers.
Salbutamol 100 mcg
This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol.
DISKUS™ powder inhalers
Participant received salmeterol and fluticasone using DISKUS™ powder inhalers.
Interventions
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Salmeterol/Fluticasone 50/250 mcg
Participant received salmeterol/fluticasone combination 50/250 mcg using DISKUS™ powder inhalers.
Salbutamol 100 mcg
This medication was provided in metered dose inhalers containing at least 200 puffs of 100 mcg salbutamol.
DISKUS™ powder inhalers
Participant received salmeterol and fluticasone using DISKUS™ powder inhalers.
Eligibility Criteria
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Inclusion Criteria
* Reversibility \>12% after inhalation of 200 µg Salbutamol
* willingness and ability to complete daily record card on daily basis and to measure morning PEF on daily basis
* 80% compliance in diary card completion asthma control status: Uncontrolled based on the GOAL criteria
Exclusion Criteria
* Asthma exacerbation characterized by use of oral corticoids during the last 3 months Pretreatment with inhaled corticosteroids more than 500 mcg Beclometasondipropionat or equivalent per day or other controller therapy during the last 3 months
* upper or lower respiratory tract infection during the RUN-IN period moderate or severe asthma exacerbation during the RUN-IN period
* Non compliance with use of Discus, PEF-meter and incomplete diary card data
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Erlangen, Bavaria, Germany
GSK Investigational Site
Kaufbeuren, Bavaria, Germany
GSK Investigational Site
Landsberg am Lech, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Munich, Bavaria, Germany
GSK Investigational Site
Rednitzhembach, Bavaria, Germany
GSK Investigational Site
Uttenreuth, Bavaria, Germany
GSK Investigational Site
Würzburg, Bavaria, Germany
GSK Investigational Site
Cottbus, Brandenburg, Germany
GSK Investigational Site
Wedel, City state of Hamburg, Germany
GSK Investigational Site
Bad Arolsen, Hesse, Germany
GSK Investigational Site
Eschwege, Hesse, Germany
GSK Investigational Site
Kassel, Hesse, Germany
GSK Investigational Site
Kassel, Hesse, Germany
GSK Investigational Site
Marburg, Hesse, Germany
GSK Investigational Site
Braunschweig, Lower Saxony, Germany
GSK Investigational Site
Buchholz, Lower Saxony, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Hanover, Lower Saxony, Germany
GSK Investigational Site
Chemnitz, Saxony, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, Germany
GSK Investigational Site
Greiz, Thuringia, Germany
GSK Investigational Site
Sonneberg, Thuringia, Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Hamburg, , Germany
Countries
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Other Identifiers
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SAM 106538
Identifier Type: -
Identifier Source: org_study_id
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