Efficacy and Safety of Fluticasone Propionate(FP)/ Salmeterol Xinafoate (SLM) Hydro Fluoro Alkane (HFA) Metered Dose Inhaler (MDI) in Pediatric Patients With Bronchial Asthma

Exclusion Criteria

• •A patient who has suffered from upper and lower respiratory tract infection and then received medication within 2 weeks prior to Visit 1.
• •A patient who is diagnosed upper and lower respiratory tract infection at Visit 1. Or a patient who has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available. Or a patient who is suspected to have respiratory syncytial (RS) virus infection and cannot be identified to be negative for RS virus antigen.
• •A patient who has respiratory disorder other than bronchial asthma, and the investigator judges the respiratory disorder affect the assessment of efficacy in this study.
• •A patient who has unstable liver disease or chronic stable hepatitis B receiving significant immunosuppressive agents due to risk of hepatitis B reactivation.
• •A patient who has malformation/foreign particle lodged in an airway. Or subjects who have known, pre-existing, clinically significant gastroesophageal reflux disease , endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
• •A patient who has or is suspected to have hypersensitivity to study medications, the rescue medication or any ingredients of them.
• •A patient who has been treated with another investigational product within 1 months prior to Visit 1 or within five half-lives (t-half) of the prior investigational study (whichever is the longer of the two).
• •As for the patients who has evaluable ECG data at Visit 1, QT interval corrected (Fridericia) for heart rate (QTc\[F\])\>=450 milliseconds (msec). The QT interval corrected for heart rate (QTc) should be based on averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period. As for the patients who don't has evaluable ECG data at Visit 1, if the patient has known prolonged QTc\>=450 msec (any correction is valid), the patient will be excluded.
• •A patient who is child in care (including foster parent system), or whom the investigator judges inappropriate for the study.
• •Randomization Inclusion Criterion :
• •A patient who has asthma symptoms scores (total of daytime and night-time) both over \>=6 in total and \>=1 per day for \>=3 days at the last 7 consecutive days of the run-in period (excluding the day of Visit 2). Completion of symptom scores (daytime and night-time) on 5 or more days out of the last 7 consecutive days during the run-in period is required.
• •A patient who has received systemic steroids during run-in period.
• •A patient who has suffered from or is suspected to have upper and lower respiratory tract infection that may affect the assessment of the efficacy during the run-in period. Or a patient who has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available during the run-in period. Or a patient who is suspected to have RS virus infection and cannot be identified to be negative for RS virus antigen during run-in period.
• •A patient who has no evaluable ECG data during the run-in period. As for the patients who has evaluable ECG data during the run-in period, QTc(F) \>=450 msec. The QTc should be based on averaged QTc values of triplicate electrocardiograms (ECGs) obtained over a brief recording period.
• •A patient who has not been able to appropriately record patient diary or inhale FP appropriately during the run-in period, in the opinion of the investigator.