Study of FlutiForm® Versus Fluticasone Plus Formoterol in Adult Subjects With Severe Asthma

Exclusion Criteria

• •1. Near fatal or life-threatening (including intubation) asthma within the past year.
• •2. Hospitalisation or an emergency visit for asthma within the 4 weeks before the screening visit.
• •3. Known history of systemic (injectable or oral) corticosteroid medication within 1 month of the Screening Visit.
• •4. Known history of omalizumab use within the past 6 months.
• •5. 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.
• •6. In the investigator's opinion a clinically significant upper or lower respiratory infection within 4 weeks prior to the Screening Visit.
• •7. Significant, non-reversible, active pulmonary disease (e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).
• •8. Known Human Immunodeficiency Virus (HIV)-positive status.
• •9. 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.).
• •10. Current smoking history within 12 months prior to the Screening Visit.
• •11. Current evidence or known history of alcohol and/or substance abuse within 12 months prior to the Screening Visit.
• •12. 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.
• •13. Current use of medications other than those allowed in the protocol that will have an effect on bronchospasm and/or pulmonary function.
• •14. Current evidence or known history of hypersensitivity or idiosyncratic reaction to test medications or components.
• •15. Subject has recieved an investigational drug within 30 days of the Screening Visit (12 weeks if an oral or injectable steroid).
• •16. Subject is currently participating in a clinical study.