This study will compare two treatment strategies (doubling the dose of inhaled steroids or
adding a long acting beta2 agonist to the inhaled steroid at the same dose) in children not
controlled by inhaled steroid alone at medium dose. The fixed combination SERETIDE 100/50
one inhalation twice daily will be compared to FLIXOTIDE 100 two inhalations twice daily.
Minimum age: 4 Years.
Maximum age: 11 Years.
Gender(s): Both.
Inclusion criteria:
- A documented clinical history of asthma for a period of at least 6 months.
- A documented history (within 12 months of Visit 1) of airway reversibility of = 15%
based either on Forced expiratory volume (FEV1) or PEF measured pre and post
inhalation of 200 mcg salbutamol. (If no documented history of reversibility exists,
patients must demonstrate a =15% reversibility at Visit 1).
- Receiving an inhaled corticosteroid at a medium dose (beclomethasone dipropionate
HydroFluoroAlkane (HFA) non fine particle = 400-500 mcg/day or beclomethasone HFA
fine particle = 200mcg/day, or budesonide =400 mcg/day or fluticasone = 200 mcg/day
(or fluticasone 250mcg/day if subject is taking a 125mcg MDI rather than the 100mcg
Diskus), for at least 3 months prior to Visit 1 and at a stable dose for at least 4
weeks prior to Visit 1.
- Able to use the Mini-Wright peak flow meter and subject or parent/guardian had to be
able to record the subject's maximum PEF correctly.
- Able to perform FEV1 correctly.
- Subject's guardian/parent able to complete an eDRC on behalf of the subject. The eDRC
should be completed by the guardian/parent.
- Able to use a DISKUS™ correctly.
- At least one parent(s)/guardian(s) has to give written informed consent to
participate in the study.
At the end of the run-in period (Visit 2), subjects must still meet the criteria for entry
into the run-in period and also have:
- not achieved the criteria for the 'Well-controlled' asthma during two or more of the
4 weeks prior to Visit 2.
Exclusion criteria:
- Female subjects who have reached menarche.
- Received any investigational study medication in the 4 weeks prior to Visit 1.
- Experienced a respiratory tract infection in the 4 weeks prior to Visit 1.
- Experienced an acute asthma exacerbation requiring emergency room treatment within 4
weeks or hospitalisation within 12 weeks of Visit 1.
- Any use of oral/parenteral or depot corticosteroid within 12 weeks of Visit 1.
- Any use of long-acting inhaled beta2-agonists or oral beta2-agonists within 4 weeks
of Visit 1.
- Any use of leukotriene antagonists or theophyllines within 4 weeks of Visit 1.
- Any known clinical or laboratory evidence of a serious uncontrolled disease
(including serious psychological disorders) which is, in the opinion of the
investigator, likely to interfere with the study.
- Subjects with a known or suspected hypersensitivity to inhaled corticosteroids,
beta2-agonists, or any components of the formulations (e. g. lactose)
- A relative of any of the site staff, including the investigator or study
co-coordinator.
- Has previously been entered into this study.
Subjects will be excluded from participating in the treatment period of the study if the
following occurred during the run-in period:
- Pre-bronchodilator FEV1 <60% (assuming that measurement was correctly performed).
- Any change in asthma medication (excluding use of prophylactic study specific
salbutamol for prevention of asthma symptoms due to exercise).
- Respiratory tract infection or asthma exacerbation.
- Use of oral, parenteral or depot corticosteroids.
- Emergency visit due to asthma.
- Non-compliance with the completion of the eDRC (i. e. during the 4 week period between
visits, non compliance is defined as less than 5 days of completed data within any
one week for four weeks - subjects must complete at least 5 days a week for the
entire run-in period).
GSK Investigational Site, Brugge 8000, Belgium
GSK Investigational Site, Brussels 1090, Belgium
GSK Investigational Site, Edegem 2650, Belgium
GSK Investigational Site, Gent 9000, Belgium
GSK Investigational Site, Leuven 3000, Belgium
GSK Investigational Site, Aalborg 9000, Denmark
GSK Investigational Site, Odense 5000 Odense C, Denmark
GSK Investigational Site, Essey les Nancy 54270, France
GSK Investigational Site, Grasse 06130, France
GSK Investigational Site, Laon 02000, France
GSK Investigational Site, Nimes 30900, France
GSK Investigational Site, Oyonnax 01100, France
GSK Investigational Site, Paris cedex 15 75730, France
GSK Investigational Site, Paris 75019, France
GSK Investigational Site, Rouen Cedex 76031, France
GSK Investigational Site, Rouen 76000, France
GSK Investigational Site, Saint Michel 16470, France
GSK Investigational Site, Tours Cedex 1 37000, France
GSK Investigational Site, Vaux en Velin 69120, France
GSK Investigational Site, Villejuif 94800, France
GSK Investigational Site, Daugavpils LV5403, Latvia
GSK Investigational Site, Riga LV 1004, Latvia
GSK Investigational Site, Riga LV 1064, Latvia
GSK Investigational Site, Kaunas LT-50425, Lithuania
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GSK Investigational Site, Den Haag 2517 EW, Netherlands
GSK Investigational Site, Deurne 5751 XJ, Netherlands
GSK Investigational Site, Emmen 7824 AA, Netherlands
GSK Investigational Site, Ermelo 3851 EX, Netherlands
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GSK Investigational Site, Spijkenisse 3207 NB, Netherlands
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GSK Investigational Site, Woerden 3447 GN, Netherlands
GSK Investigational Site, Drammen N-3018, Norway
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GSK Investigational Site, Lodz 93-513, Poland
GSK Investigational Site, Lublin 20-093, Poland
GSK Investigational Site, Krasnoyarsk 660022, Russian Federation
GSK Investigational Site, Moscow 115446, Russian Federation
GSK Investigational Site, Moscow 119435, Russian Federation
GSK Investigational Site, Moscow 119991, Russian Federation
GSK Investigational Site, Novokuznetsk 654063, Russian Federation
GSK Investigational Site, Novosibirsk 630099, Russian Federation
GSK Investigational Site, St'Petersburg 191144, Russian Federation
GSK Investigational Site, Syktyvkar 167011, Russian Federation
GSK Investigational Site, Tomsk 634 050, Russian Federation
GSK Investigational Site, Almeria 04009, Spain
GSK Investigational Site, Barcelona 08035, Spain
GSK Investigational Site, Madrid 28006, Spain
GSK Investigational Site, Madrid 28009, Spain
GSK Investigational Site, San Sebastián 20014, Spain
GSK Investigational Site, Sevilla 41071, Spain
GSK Investigational Site, Sollentuna SE-191 24, Sweden
GSK Investigational Site, Stockholm SE-141 86, Sweden
GSK Investigational Site, Stockholm SE-171 76, Sweden
GSK Investigational Site, Napoli, Campania 80138, Italy
GSK Investigational Site, Foggia, Puglia 71100, Italy
GSK Investigational Site, Palermo, Sicilia 90127, Italy
GSK Investigational Site, Perugia, Umbria 06122, Italy