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

Progress of Enrollment, Updated Annually: This study has been completed and the final
clinical study report was submitted to the FDA in May of 2016. This is the final update, as
this study is complete.

Inclusion Criteria:

1. Consent to participate in the study

2. Age 4-11 years old

3. Male or eligible female - Female subjects should not be enrolled if they are pregnant,
lactating or plan to become pregnant during the time of study participation

4. Asthma diagnosis for at least 6 months

5. Ability to answer questions regarding asthma control and use a metered dose inhaler
and DISKUS

6. A history of clinical varicella infection or recipient of a varicella vaccine in
countries where the product label includes a warning regarding more serious chickenpox
infections in patients using corticosteroids.

7. History of at least once occurrence of asthma exacerbation within the prior 12 months

8. Currently being treated for asthma and no change in asthma therapy for the last 4
weeks (Eligible subjects include: subjects with use of short-acting beta-agonist,
leukotriene receptor antagonist, theophylline, or cromolyn whose asthma is not
well-controlled; subjects on low-dose ICS monotherapy whose asthma is not
well-controlled; subjects on low-dose ICS and one or more adjunctive therapy whose
asthma is either controlled or not well-controlled asthma; subjects on medium-dose ICS
monotherapy whose asthma is either controlled or not well-controlled; and subjects on
medium-dose ICS and one or more adjunctive therapy whose asthma is well-controlled)

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.