Efficacy of FLUTIFORM ® vs Seretide® in Moderate to Severe Persistent Asthma in Subjects Aged ≥12 Years

Exclusion Criteria

• •1. Demonstrated a pre-dose FEV1 of ≥ 40% to ≤ 80% for predicted normal values at Randomisation Visit (Visit 3) following appropriate withholding of asthma medications (if applicable).
• •2. ACQ score at Visit 3 ≥ 1.0.
• •3. Subjects with a good compliance with treatment or patient dairy. The definition of good compliance is that the completeness of diary during the last 14 days of the run-in period is at least 80%. The compliance on diary completeness will be assessed from the aspects below and agreed by the investigator and study Medical Monitor:
• •1. Diary info has been filled out on ≥80% of the days during the last 14 days before randomization (e.g., at least 11 days with diary filled completed out of the last 14 days prior to randomization).
• •2. 80% main items including the study endpoints related ones have been filled out within the last 14 days prior to randomization.
• •3. No other significant incompliance judged by the investigator that indicates the potential future incompliance for critical data collection during the study treatment period.
• •1. The adolescent subjects (age ≥ 12 years to \<18 years) who are on ICS alone at a dose \>250μg bid fluticasone or equivalent OR ICS-LABA combination at a dose of Seretide \> 250/50 μg bid or equivalent.
• •2. Near fatal or life-threatening (including intubation) asthma within the past year.
• •3. Chest X-ray at the Investigator's discretion from clinical perspective that reveals evidence of clinically significant abnormalities not believed to be due to asthma.
• •4. Hospitalization or an emergency visit for asthma within the 4 weeks before the screening visit or during the screening visit.
• •5. Use of systemic (injectable or oral) corticosteroid medication within 1 month of the Screening Visit.
• •6. Omalizumab use within the past 6 months prior to the Screening Visit.
• •7. Current evidence or known history of any clinically significant disease or abnormality including uncontrolled coronary artery disease, congestive heart failure, myocardial infarction, or cardiac dysrhythmia. 'Clinically significant' is defined as any disease that, in the opinion of the Investigator, would put the subject at risk through study participation, or which would affect the outcome of the study.
• •8. In the investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
• •9. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
• •10. Subject has a smoking history equivalent to ≥ 10 pack years (i.e., at least 1 pack of 20 cigarettes /day for 10 years or 10 packs/day for 1 year, etc.) or significant history of exposure to biomass fuel combustion which may be considered a plausible contributory cause to the subject's obstructive lung disease.
• •11. Current smoking history within 12 months prior to the Screening Visit.
• •12. Current evidence or known history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
• •13. Subject has taken B-blocking agents, tricyclic antidepressants, monoamine oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent CYP 3A4 inhibitors such as ketoconazole within the past week.
• •14. Current use of medications other than those allowed in the protocol that will have an effect on bronchospasm and/or pulmonary function.
• •15. Current evidence or known history of hypersensitivity or contraindications to the investigational products or components, including the history of paradoxical bronchospasm after inhalation therapy as immediate increase in wheezing and shortness of breath.
• •16. Subject has received an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
• •17. Subject is currently participating in another clinical study or has already been randomized in this study.
• •18. Mental incapacity, unwillingness, or language barrier precluding adequate understanding, cooperation or any factors might block patients from protocol defined visits and may impact the patient diary completion at the Investigator's discretion.