Status:
COMPLETED
MGR001 / Advair Diskus Local Equivalence Study in Asthma
Lead Sponsor:
Mylan Pharma UK Ltd.
Conditions:
Asthma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when administered by inhalation in adult asthma patients
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
1128 Patients enrolled
Trial Details
Trial ID
NCT02245672
Start Date
October 1 2014
End Date
July 1 2015
Last Update
February 24 2022
Active Locations (101)
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1
Mylan Investigative Site #1
Birmingham, Alabama, United States, 35209
2
Mylan Investigative Site #2
Little Rock, Arkansas, United States, 72205
3
Mylan Investigative Site #3
Anaheim, California, United States, 92801
4
Mylan Investigative Site #4
Bakersfield, California, United States, 93301