MGR001 / Advair Diskus Local Equivalence Study in Asthma
- Conditions
- Asthma
- Interventions
- Drug: PlaceboDrug: MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)
- Registration Number
- NCT02245672
- Lead Sponsor
- Mylan Pharma UK Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1128
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study MGR001 MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) MGR001 administered two times per day by inhalation throughout the study Advair Diskus Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) Advair Diskus administered two times per day by inhalation throughout the study
- Primary Outcome Measures
Name Time Method FEV1 Trough Value (Bioequivalence) Day 1 and Day 29 Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of \[prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1\]
Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence) 0-12 hours after dosing on Day 1 The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures
Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity) 0-12 hours after dosing on Day 1 The FEV1 AUEC(0-12) on Day 1 was calculated from FEV1 measurements collected 30 minutes prior to morning dose, 0 minutes prior to morning dose, and at 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours following completion of dosing on Day 1 (Visit 3). The baseline for the FEV1 AUEC(0-12) endpoint was the mean of the 2 predose FEV1 measures. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo
FEV1 Trough Value (Assay Sensitivity) Day 1 and Day 29 Change from baseline in trough (pre-dose) FEV1 at Day 29 was based on 2 pre-dose FEV1 assessments performed 30 minutes apart on Day 29. Baseline was calculated by taking the mean of \[prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1\]. To confirm assay sensitivity, both active treatments (MGR001 and Advair Diskus) had to be significantly superior to placebo.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (101)
Mylan Investigative Site #14
🇺🇸Los Angeles, California, United States
Mylan Investigative Site #42
🇺🇸Bangor, Maine, United States
Mylan Investigative Site #74
🇺🇸Medford, Oregon, United States
Mylan Investigative Site #43
🇺🇸Baltimore, Maryland, United States
Mylan Investigative Site #86
🇺🇸Dallas, Texas, United States
Mylan Investigative Site #65
🇺🇸Canton, Ohio, United States
Mylan Investigative Site #63
🇺🇸Charlotte, North Carolina, United States
Mylan Investigative Site #46
🇺🇸White Marsh, Maryland, United States
Mylan Investigative Site #57
🇺🇸Bellevue, Nebraska, United States
Mylan Investigative Site #47
🇺🇸Fall River, Massachusetts, United States
Mylan Investigative Site #79
🇺🇸Providence, Rhode Island, United States
Mylan Investigative Site #68
🇺🇸Sylvania, Ohio, United States
Mylan Investigative Site #92
🇺🇸Waco, Texas, United States
Mylan Investigative Site #53
🇺🇸Saint Louis, Missouri, United States
Mylan Investigative Site #45
🇺🇸Wheaton, Maryland, United States
Mylan Investigative Site #54
🇺🇸Warrensburg, Missouri, United States
Mylan Investigative Site #61
🇺🇸New York, New York, United States
Mylan Investigative Site #51
🇺🇸Columbia, Missouri, United States
Mylan Investigative Site #52
🇺🇸Rolla, Missouri, United States
Mylan Investigative Site #69
🇺🇸Toledo, Ohio, United States
Mylan Investigative Site #64
🇺🇸Raleigh, North Carolina, United States
Mylan Investigative Site #72
🇺🇸Eugene, Oregon, United States
Mylan Investigative Site #62
🇺🇸Asheville, North Carolina, United States
Mylan Investigative Site #94
🇺🇸South Burlington, Vermont, United States
Mylan Investigative Site #71
🇺🇸Tulsa, Oklahoma, United States
Mylan Investigative Site #93
🇺🇸Provo, Utah, United States
Mylan Investigative Site #87
🇺🇸Dickinson, Texas, United States
Mylan Investigative Site #95
🇺🇸Henrico, Virginia, United States
Mylan Investigative Site #100
🇺🇸Greenfield, Wisconsin, United States
Mylan Investigative Site #88
🇺🇸El Paso, Texas, United States
Mylan Investigative Site #96
🇺🇸Seattle, Washington, United States
Mylan Investigative Site #35
🇺🇸Miami, Florida, United States
Mylan Investigative Site #66
🇺🇸Cincinnati, Ohio, United States
Mylan Investigative Site #67
🇺🇸Cincinnati, Ohio, United States
Mylan Investigative Site #41
🇺🇸Lenexa, Kansas, United States
Mylan Investigative Site #50
🇺🇸Minneapolis, Minnesota, United States
Mylan Investigative Site #90
🇺🇸San Antonio, Texas, United States
Mylan Investigative Site #7
🇺🇸Encinitas, California, United States
Mylan Investigative Site #9
🇺🇸Fullerton, California, United States
Mylan Investigative Site #3
🇺🇸Anaheim, California, United States
Mylan Investigative Site #4
🇺🇸Bakersfield, California, United States
Mylan Investigative Site #5
🇺🇸Burbank, California, United States
Mylan Investigative Site #6
🇺🇸Costa Mesa, California, United States
Mylan Investigative Site #10
🇺🇸Huntington Beach, California, United States
Mylan Investigative Site #11
🇺🇸Huntington Beach, California, United States
Mylan Investigative Site #12
🇺🇸Los Angeles, California, United States
Mylan Investigative Site #13
🇺🇸Los Angeles, California, United States
Mylan Investigative Site #16
🇺🇸Napa, California, United States
Mylan Investigative Site #15
🇺🇸Mission Viejo, California, United States
Mylan Investigative Site #17
🇺🇸Orange, California, United States
Mylan Investigative Site #18
🇺🇸Riverside, California, United States
Mylan Investigational Site #27
🇺🇸Rolling Hills Estates, California, United States
Mylan Investigative Site #20
🇺🇸San Diego, California, United States
Mylan Investigative Site #21
🇺🇸San Jose, California, United States
Mylan Investigative Site #101
🇺🇸Centennial, Colorado, United States
Mylan Investigative Site #22
🇺🇸Centennial, Colorado, United States
Mylan Investigative Site #23
🇺🇸Colorado Springs, Colorado, United States
Mylan Investigative Site #24
🇺🇸Colorado Springs, Colorado, United States
Mylan Investigative Site #28
🇺🇸Coral Gables, Florida, United States
Mylan Investigative Site #26
🇺🇸Wheat Ridge, Colorado, United States
Mylan Investigative Site #30
🇺🇸Hialeah, Florida, United States
Mylan Investigative Site #31
🇺🇸Largo, Florida, United States
Mylan Investigative Site #32
🇺🇸Miami, Florida, United States
Mylan Investigative Site #34
🇺🇸Miami, Florida, United States
Mylan Investigative Site #33
🇺🇸Miami, Florida, United States
Mylan Investigative Site #36
🇺🇸New Port Richey, Florida, United States
Mylan Investigative Site #37
🇺🇸Tallahassee, Florida, United States
Mylan Investigative Site #38
🇺🇸Lawrenceville, Georgia, United States
Mylan Investigative Site #39
🇺🇸River Forest, Illinois, United States
Mylan Investigative Site #40
🇺🇸Shiloh, Illinois, United States
Mylan Investigative Site #8
🇺🇸Fresno, California, United States
Mylan Investigative Site #76
🇺🇸Jenkintown, Pennsylvania, United States
Mylan Investigative Site #77
🇺🇸Pittsburgh, Pennsylvania, United States
Mylan Investigative Site #78
🇺🇸Smithfield, Pennsylvania, United States
Mylan Investigative Site #80
🇺🇸Warwick, Rhode Island, United States
Mylan Investigative Site #84
🇺🇸Boerne, Texas, United States
Mylan Investigative Site #89
🇺🇸New Braunfels, Texas, United States
Mylan Investigative Site #85
🇺🇸Dallas, Texas, United States
Mylan Investigative Site #91
🇺🇸San Antonio, Texas, United States
Mylan Investigative Site #97
🇺🇸Spokane, Washington, United States
Mylan Investigative Site #98
🇺🇸Tacoma, Washington, United States
Mylan Investigative Site #99
🇺🇸Tacoma, Washington, United States
Mylan Investigative Site #1
🇺🇸Birmingham, Alabama, United States
Mylan Investigative Site #19
🇺🇸Sacramento, California, United States
Mylan Investigative Site #25
🇺🇸Denver, Colorado, United States
Mylan Investigative Site #44
🇺🇸Bethesda, Maryland, United States
Mylan Investigative Site #70
🇺🇸Oklahoma City, Oklahoma, United States
Mylan Investigative Site #48
🇺🇸North Dartmouth, Massachusetts, United States
Mylan Investigative Site #58
🇺🇸Brick, New Jersey, United States
Mylan Investigative Site #56
🇺🇸Missoula, Montana, United States
Mylan Investigative Site #75
🇺🇸Portland, Oregon, United States
Mylan Investigative Site #49
🇺🇸North Dartmouth, Massachusetts, United States
Mylan Investigative Site #60
🇺🇸Skillman, New Jersey, United States
Mylan Investigative Site #2
🇺🇸Little Rock, Arkansas, United States
Mylan Investigative Site #55
🇺🇸Bozeman, Montana, United States
Mylan Investigative Site #59
🇺🇸Ocean City, New Jersey, United States
Mylan Investigative Site #73
🇺🇸Lake Oswego, Oregon, United States
Mylan Investigative Site #81
🇺🇸North Charleston, South Carolina, United States
Mylan Investigative Site #82
🇺🇸Spartanburg, South Carolina, United States
Mylan Investigative Site #83
🇺🇸Spartanburg, South Carolina, United States
Mylan Investigative Site #29
🇺🇸Gainesville, Florida, United States