Seretide Versus Flixotide In Asthmatic Children Not Controlled By Inhaled Corticosteroids
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone propionate; Fluticasone propionate/salmeterol
Intervention description: 200μg twice daily; 50/100μg twice daily
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 506.0
Sex: All
Minimum age: 4 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: FLIXOTIDE; asthmatics children 4-11 years; SERETIDE; asthma-control

Summary:

      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.
    

Eligibility criteria:

        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).