6-month Safety and Benefit Study of ADVAIR in Children 4-11 Years Old

Exclusion Criteria

• •1. History of life-threatening asthma
• •2. Unstable asthma
• •3. Current use of high-dose ICS or ICS/LABA therapy to treat asthma symptoms
• •4. Concurrent respiratory disease: Current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, allergic bronchopulmonary aspergillosis, cystic fibrosis, bronchopulmonary dysplasia, or other severe respiratory abnormalities other than asthma.
• •5. Respiratory infection
• •6. Subjects with only exercise-induced asthma
• •7. An asthma exacerbation within the last 4 weeks or more than 4 separate exacerbations in the last 12 months
• •8. Hospitalization for asthma within 4 weeks or more than 2 hospitalizations within the last 12 months
• •9. Other current evidence of clinically significant uncontrolled disease/conditions of any body or organ system
• •10. Neurological or psychiatric disease or history of drug or alcohol abuse of a subject or his/her guardian which in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirements
• •11. Participation in an interventional study or used any investigational drug for any disease state within the last 30 days
• •12. Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy, or vehicle contained within these medication
• •13. Severe hypersensitivity to cow's milk proteins
• •14. Administration of prescription or over the counter medications that would significantly affect the course of asthma, or interact with sympathomimetic amines such as: anti-IgE (omalizumab), anticonvulsants (barbiturates, hydantoins, carbamazepine); polycyclic antidepressants, beta-adrenergic blockers; phenothiazines, monoamine oxidase inhibitors, or diuretics
• •15. Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
• •16. Affiliation with investigator's site, including a immediate family member of the participating investigator, sub-investigator, study coordinator, or employee of the participating investigator.
• •17. A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.