MGR001 / Advair Diskus Local Equivalence Study in Asthma

Key inclusion criteria include:

- Male or female subjects aged ≥18 years. Females may be of either childbearing or
non-childbearing potential

- Physician diagnosed history of asthma for at least 12 weeks prior to screening

- pre-bronchodilator FEV1 60-85% at screening and other specified visits

- Post-bronchodilator reversibility >/=12%

- Non-smokers and prior smokers with no history of smoking within the past 12 months
prior to screening and a total smoking history of ≤10 pack-years

- Subjects able to discontinue asthma medications for the duration of the study and be
maintained using albuterol as required

- Body mass index between 18-40 kg/m2 inclusive

Key exclusion criteria include:

- Presence or recent history of any other active, severe, progressive, and/or
uncontrolled clinical disease, eg, poorly controlled Type 1 or 2 diabetes, seizure
disorder or epilepsy, cerebrovascular accident, significant cardiac conduction
abnormalities

- Respiratory conditions other than asthma and allergic rhinitis, including but not
limited to: severe nasal polyposis or chronic rhinosinusitis, chronic obstructive
pulmonary disease, bronchiectasis, Churg-Strauss Disease, lung resection, pulmonary
fibrosis (primary or secondary), pulmonary hypertension, cystic fibrosis, sarcoidosis

- History of life-threatening asthma, defined as a history of asthma episode(s)
requiring intubation, and/or associated with hypercapnia; respiratory arrest or
hypoxic seizures, asthma related syncopal episode(s)

- In patient hospitalization (not including ER visits) for an asthma exacerbation
within the past year or during the run in period

- An asthma exacerbation requiring change in asthma therapy or oral/IV corticosteroids
in the 3 months prior to screening

- History of seasonally unstable asthma where the season will coincide with the
subject's participation in the study

- Use of prescription or non-prescription drugs, including beta blockers, tricyclic
antidepressants, oral decongestants, benzodiazepines, digitalis, phenothiazines,
monoamine oxidase inhibitors, etc

- Suspected hypersensitivity to the study drugs (including lactose) or severe milk
protein allergy

- Clinically significant abnormalities in the screening ECG

- Evidence of alcohol or drug abuse or dependency within 6 months prior to screening