Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
Condition: Bronchial Asthma
MeSH terms: Asthma
Intervention: GW815SF HFA MDI; salmeterol and fluticasone propionate
Intervention description: salmeterol and fluticasone propionate combination; salmeterol + fluticasone propionate
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 5 Years
Maximum age: 14 Years
Healthy volunteers: No
Keywords: Salmeterol; Fluticasone propionate; Salmeterol/Fluticasone propionate combination; Pediatric bronchial asthma

Summary:

      To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison
      with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus
      fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma.

      To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in
      paediatric patients with 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 1 and if she agrees to undergo pregnancy
             testing at the protocol-specified timings and to take contraceptive measures without
             fail.

          -  Written informed consent must be obtained from a 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 100μg/day or equivalent) for at least
             4 weeks prior to Visit 1.

          -  Able to use a peak flow meter in a correct manner in the
             investigator's/subinvestigator's judgment.

          -  Able to use MDI and DPI 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 1 A subject will be randomized to one of
        the two treatment groups only if he/she has completed the run-in period and meets all the
        following criteria.

          1. Has a mean of morning PEF measurements in the last 7 days of the run-in period
             (excluding the first day of Treatment Period 1) ≤90% of his/her best PEF measurement .

          2. Was able to perform entry in the asthma diary and PEF measurements in a correct manner
             in the investigator's/subinvestigator's judgment.

          3. Able to use MDI and DPI in a correct manner (with the assistance of his/her caregiver
             as necessary) in the investigator's/subinvestigator's judgment.

        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 1

        Enrolment of a subject completing the run-in period into Treatment Period 1 will not be
        allowed if any of the following applies:

          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.

        Exclusion Criteria for Entry in Treatment Period 2

        Enrolment of a subject completing the washout period into Treatment Period 2 will not be
        allowed if any of the following applies:

          1. Admitted to the hospital due to asthma exacerbation during the washout period.

          2. Had upper or lower respiratory tract infection during the 2 weeks just before Visit 4.

          3. Used prohibited drugs during the 2 weeks just before Visit 4.

          4. Is not eligible for entry in Treatment Period 2 in the
             investigator's/subinvestigator's judgment.