MGR001 / Advair Diskus Local Equivalence Study in Asthma



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2014
End Date:July 2015

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A Randomized, Double-blind, Double Dummy, Parallel Group Study to Determine the Local Equivalence of Multiple Doses of MGR001 to Advair Diskus Administered Via Oral Inhalation in Adult Asthma Patients

The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when
administered by inhalation in adult asthma patients


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
We found this trial at
101
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Anaheim, California 92801
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Asheville, North Carolina 28801
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Bethesda, Maryland 20814
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