Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-
Condition: Bronchial Asthma
MeSH terms: Asthma
Intervention: GW815SF Salmeterol/Fluticasone propionate(HFA MDI)
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 5 Years
Maximum age: 14 Years
Healthy volunteers: No
Keywords: salmeterol/fluticasone propionate combination; pediatric bronchial asthma

Summary:

      This study evaluates the long-term (24-week) safety and efficacy of GW815SF
      Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of
      25/50mcg) bid in pediatric patients with bronchial asthma.
    

Eligibility criteria:

        Inclusion criteria:

          -  Inclusion Criteria for Entry in Run-in Period

        A pediatric patient already diagnosed as having bronchial asthma who meets all of the
        following criteria is eligible for the study:

          -  Male or female patients aged ≥5 and ≤14 years. Enrolment of a female patient of
             childbearing potential is allowed only if she is tested negative in the pregnancy
             testing at the start of treatment period and if she agrees to undergo pregnancy
             testing at the protocol-specified timings and to take contraceptive measures without
             fail during the study period.

          -  Written informed consent must be obtained from the legally acceptable representative
             of the subject. Consent of the subject him/herself should also be obtained, wherever
             possible, after giving an explanation in an as easy to understand as possible manner.

          -  An outpatient who has been treated with ICS (FP 100-200μg/day or equivalent) for at
             least 4 weeks prior to Visit 1.

          -  Is suitable, in the investigator's/subinvestigator's judgment, for treatment with
             GW815SF HFA MDI 25/50μg (administered as 2 inhalations of 25/50μg) bid.

          -  Able to use a peak flow meter in a correct manner in the
             investigator's/subinvestigator's judgment.

          -  Able to use MDI in a correct manner (with the assistance of his/her caregiver as
             necessary) in the investigator's/subinvestigator's judgment.

        Inclusion Criteria for Entry in Treatment Period A subject will be considered eligible for
        inclusion in the treatment period only if he/she has completed the run-in period and meets
        the following criterion.

        1. Has been able, in the investigator's/subinvestigator's judgment, to make entries in the
        asthma diary and measure PEF, as directed, during the run-in period.

        Exclusion criteria:

          -  Exclusion Criteria for Entry in Run-in Period

        A patient who applies any of the following criteria is not eligible for the study:

          -  Admitted to the hospital due to asthma exacerbation within 8 weeks prior to Visit 1.

          -  Used systemic steroid within 4 weeks prior to Visit 1.

          -  Received antibacterials or antivirals for treatment of upper or lower respiratory
             tract infection within 2 weeks prior to Visit 1.

          -  Has a safety problem in participation in the study because of a serious, uncontrolled
             systemic disease including nervous system disorder.

          -  Has or is suspected to have deep-seated mycosis or infection to which no effective
             antibacterial agent is available.

          -  Has or is suspected to have hypersensitivity to the investigational product, rescue
             medication or any ingredients of them.

          -  Is pregnant or lactating, may be pregnant, or plans for pregnancy during the study
             period.

          -  Has received the last dose in another clinical study within 2 months prior to this
             study.

          -  Is not eligible for the study in the investigator's/subinvestigator's judgment.

        Exclusion Criteria for Entry in Treatment Period

        A subject who applies to any of the following criteria is not eligible for the study:

          1. Admitted to the hospital due to asthma exacerbation during the run-in period.

          2. Had upper or lower respiratory tract infection during the 2 weeks just before Visit 2.

          3. Used prohibited drugs during the 2 weeks just before Visit 2.

          4. Is not eligible for the study in the investigator's/subinvestigator's judgment.