MGR001 / Advair Diskus Local Equivalence Study in Asthma

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mylan Inc.
• Collaborator: Mylan Pharmaceuticals
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate; Xhance

Criteria

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