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.
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).
