Clinical trial NCT02245672: MGR001 / Advair Diskus Local Equivalence Study in Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
fluticasone
salmeterol
CRC749
Diskus
Advair
FEV1
MGR001
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-19
Enrollment: 1128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 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

Primary outcomes:
measure: Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity)
timeFrame: 0-12 hours after dosing on Day 1
measure: Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence)
timeFrame: 0-12 hours after dosing on Day 1
measure: FEV1 Trough Value (Assay Sensitivity)
timeFrame: Day 1 and Day 29
measure: FEV1 Trough Value (Bioequivalence)
timeFrame: Day 1 and Day 29
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Mylan Investigative Site #1
state: Alabama
city: Little Rock
country: United States
facility: Mylan Investigative Site #2
state: Arkansas
city: Anaheim
country: United States
facility: Mylan Investigative Site #3
state: California
city: Bakersfield
country: United States
facility: Mylan Investigative Site #4
state: California
city: Burbank
country: United States
facility: Mylan Investigative Site #5
state: California
city: Costa Mesa
country: United States
facility: Mylan Investigative Site #6
state: California
city: Encinitas
country: United States
facility: Mylan Investigative Site #7
state: California
city: Fresno
country: United States
facility: Mylan Investigative Site #8
state: California
city: Fullerton
country: United States
facility: Mylan Investigative Site #9
state: California
city: Huntington Beach
country: United States
facility: Mylan Investigative Site #10
state: California
city: Huntington Beach
country: United States
facility: Mylan Investigative Site #11
state: California
city: Los Angeles
country: United States
facility: Mylan Investigative Site #12
state: California
city: Los Angeles
country: United States
facility: Mylan Investigative Site #13
state: California
city: Los Angeles
country: United States
facility: Mylan Investigative Site #14
state: California
city: Mission Viejo
country: United States
facility: Mylan Investigative Site #15
state: California
city: Napa
country: United States
facility: Mylan Investigative Site #16
state: California
city: Orange
country: United States
facility: Mylan Investigative Site #17
state: California
city: Riverside
country: United States
facility: Mylan Investigative Site #18
state: California
city: Rolling Hills Estates
country: United States
facility: Mylan Investigational Site #27
state: California
city: Sacramento
country: United States
facility: Mylan Investigative Site #19
state: California
city: San Diego
country: United States
facility: Mylan Investigative Site #20
state: California
city: San Jose
country: United States
facility: Mylan Investigative Site #21
state: California
city: Centennial
country: United States
facility: Mylan Investigative Site #101
state: Colorado
city: Centennial
country: United States
facility: Mylan Investigative Site #22
state: Colorado
city: Colorado Springs
country: United States
facility: Mylan Investigative Site #23
state: Colorado
city: Colorado Springs
country: United States
facility: Mylan Investigative Site #24
state: Colorado
city: Denver
country: United States
facility: Mylan Investigative Site #25
state: Colorado
city: Wheat Ridge
country: United States
facility: Mylan Investigative Site #26
state: Colorado
city: Coral Gables
country: United States
facility: Mylan Investigative Site #28
state: Florida
city: Gainesville
country: United States
facility: Mylan Investigative Site #29
state: Florida
city: Hialeah
country: United States
facility: Mylan Investigative Site #30
state: Florida
city: Largo
country: United States
facility: Mylan Investigative Site #31
state: Florida
city: Miami
country: United States
facility: Mylan Investigative Site #32
state: Florida
city: Miami
country: United States
facility: Mylan Investigative Site #34
state: Florida
city: Miami
country: United States
facility: Mylan Investigative Site #33
state: Florida
city: Miami
country: United States
facility: Mylan Investigative Site #35
state: Florida
city: New Port Richey
country: United States
facility: Mylan Investigative Site #36
state: Florida
city: Tallahassee
country: United States
facility: Mylan Investigative Site #37
state: Florida
city: Lawrenceville
country: United States
facility: Mylan Investigative Site #38
state: Georgia
city: River Forest
country: United States
facility: Mylan Investigative Site #39
state: Illinois
city: Shiloh
country: United States
facility: Mylan Investigative Site #40
state: Illinois
city: Lenexa
country: United States
facility: Mylan Investigative Site #41
state: Kansas
city: Bangor
country: United States
facility: Mylan Investigative Site #42
state: Maine
city: Baltimore
country: United States
facility: Mylan Investigative Site #43
state: Maryland
city: Bethesda
country: United States
facility: Mylan Investigative Site #44
state: Maryland
city: Wheaton
country: United States
facility: Mylan Investigative Site #45
state: Maryland
city: White Marsh
country: United States
facility: Mylan Investigative Site #46
state: Maryland
city: Fall River
country: United States
facility: Mylan Investigative Site #47
state: Massachusetts
city: North Dartmouth
country: United States
facility: Mylan Investigative Site #48
state: Massachusetts
city: North Dartmouth
country: United States
facility: Mylan Investigative Site #49
state: Massachusetts
city: Minneapolis
country: United States
facility: Mylan Investigative Site #50
state: Minnesota
city: Columbia
country: United States
facility: Mylan Investigative Site #51
state: Missouri
city: Rolla
country: United States
facility: Mylan Investigative Site #52
state: Missouri
city: Saint Louis
country: United States
facility: Mylan Investigative Site #53
state: Missouri
city: Warrensburg
country: United States
facility: Mylan Investigative Site #54
state: Missouri
city: Bozeman
country: United States
facility: Mylan Investigative Site #55
state: Montana
city: Missoula
country: United States
facility: Mylan Investigative Site #56
state: Montana
city: Bellevue
country: United States
facility: Mylan Investigative Site #57
state: Nebraska
city: Brick
country: United States
facility: Mylan Investigative Site #58
state: New Jersey
city: Ocean City
country: United States
facility: Mylan Investigative Site #59
state: New Jersey
city: Skillman
country: United States
facility: Mylan Investigative Site #60
state: New Jersey
city: New York
country: United States
facility: Mylan Investigative Site #61
state: New York
city: Asheville
country: United States
facility: Mylan Investigative Site #62
state: North Carolina
city: Charlotte
country: United States
facility: Mylan Investigative Site #63
state: North Carolina
city: Raleigh
country: United States
facility: Mylan Investigative Site #64
state: North Carolina
city: Canton
country: United States
facility: Mylan Investigative Site #65
state: Ohio
city: Cincinnati
country: United States
facility: Mylan Investigative Site #66
state: Ohio
city: Cincinnati
country: United States
facility: Mylan Investigative Site #67
state: Ohio
city: Sylvania
country: United States
facility: Mylan Investigative Site #68
state: Ohio
city: Toledo
country: United States
facility: Mylan Investigative Site #69
state: Ohio
city: Oklahoma City
country: United States
facility: Mylan Investigative Site #70
state: Oklahoma
city: Tulsa
country: United States
facility: Mylan Investigative Site #71
state: Oklahoma
city: Eugene
country: United States
facility: Mylan Investigative Site #72
state: Oregon
city: Lake Oswego
country: United States
facility: Mylan Investigative Site #73
state: Oregon
city: Medford
country: United States
facility: Mylan Investigative Site #74
state: Oregon
city: Portland
country: United States
facility: Mylan Investigative Site #75
state: Oregon
city: Jenkintown
country: United States
facility: Mylan Investigative Site #76
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Mylan Investigative Site #77
state: Pennsylvania
city: Smithfield
country: United States
facility: Mylan Investigative Site #78
state: Pennsylvania
city: Providence
country: United States
facility: Mylan Investigative Site #79
state: Rhode Island
city: Warwick
country: United States
facility: Mylan Investigative Site #80
state: Rhode Island
city: North Charleston
country: United States
facility: Mylan Investigative Site #81
state: South Carolina
city: Spartanburg
country: United States
facility: Mylan Investigative Site #82
state: South Carolina
city: Spartanburg
country: United States
facility: Mylan Investigative Site #83
state: South Carolina
city: Boerne
country: United States
facility: Mylan Investigative Site #84
state: Texas
city: Dallas
country: United States
facility: Mylan Investigative Site #85
state: Texas
city: Dallas
country: United States
facility: Mylan Investigative Site #86
state: Texas
city: Dickinson
country: United States
facility: Mylan Investigative Site #87
state: Texas
city: El Paso
country: United States
facility: Mylan Investigative Site #88
state: Texas
city: New Braunfels
country: United States
facility: Mylan Investigative Site #89
state: Texas
city: San Antonio
country: United States
facility: Mylan Investigative Site #90
state: Texas
city: San Antonio
country: United States
facility: Mylan Investigative Site #91
state: Texas
city: Waco
country: United States
facility: Mylan Investigative Site #92
state: Texas
city: Provo
country: United States
facility: Mylan Investigative Site #93
state: Utah
city: South Burlington
country: United States
facility: Mylan Investigative Site #94
state: Vermont
city: Henrico
country: United States
facility: Mylan Investigative Site #95
state: Virginia
city: Seattle
country: United States
facility: Mylan Investigative Site #96
state: Washington
city: Spokane
country: United States
facility: Mylan Investigative Site #97
state: Washington
city: Tacoma
country: United States
facility: Mylan Investigative Site #98
state: Washington
city: Tacoma
country: United States
facility: Mylan Investigative Site #99
state: Washington
city: Greenfield
country: United States
facility: Mylan Investigative Site #100
state: Wisconsin
Study officials:
affiliation: Mylan Pharma UK Ltd.
name: Dik WH Ng, PhD
role: STUDY_DIRECTOR
References:
citation: Ng D, Kerwin EM, White MV, Miller SD, Haughie S, Ward JK, Allan R. Clinical Bioequivalence of Wixela Inhub and Advair Diskus in Adults With Asthma. J Aerosol Med Pulm Drug Deliv. 2020 Apr;33(2):99-107. doi: 10.1089/jamp.2019.1547. Epub 2019 Oct 31.