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MGR001 / Advair Diskus Local Equivalence Study in Asthma

NCT ID: NCT02245672

Last Updated: 2022-02-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-07-31

Brief Summary

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

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MGR001

MGR001 administered two times per day by inhalation throughout the study

Group Type EXPERIMENTAL

MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)

Intervention Type DRUG

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device

Advair Diskus

Advair Diskus administered two times per day by inhalation throughout the study

Group Type ACTIVE_COMPARATOR

Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)

Intervention Type DRUG

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device

Placebo

Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered via the CRC749 and Diskus devices

Interventions

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MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device

Intervention Type DRUG

Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)

Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device

Intervention Type DRUG

Placebo

Placebo administered via the CRC749 and Diskus devices

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mylan Pharma UK Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dik WH Ng, PhD

Role: STUDY_DIRECTOR

Mylan Pharma UK Ltd.

Locations

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Mylan Investigative Site #1

Birmingham, Alabama, United States

Site Status

Mylan Investigative Site #2

Little Rock, Arkansas, United States

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Mylan Investigative Site #3

Anaheim, California, United States

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Mylan Investigative Site #4

Bakersfield, California, United States

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Mylan Investigative Site #5

Burbank, California, United States

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Mylan Investigative Site #6

Costa Mesa, California, United States

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Mylan Investigative Site #7

Encinitas, California, United States

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Mylan Investigative Site #8

Fresno, California, United States

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Mylan Investigative Site #9

Fullerton, California, United States

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Mylan Investigative Site #10

Huntington Beach, California, United States

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Mylan Investigative Site #11

Huntington Beach, California, United States

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Mylan Investigative Site #12

Los Angeles, California, United States

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Mylan Investigative Site #13

Los Angeles, California, United States

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Mylan Investigative Site #14

Los Angeles, California, United States

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Mylan Investigative Site #15

Mission Viejo, California, United States

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Mylan Investigative Site #16

Napa, California, United States

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Mylan Investigative Site #17

Orange, California, United States

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Mylan Investigative Site #18

Riverside, California, United States

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Mylan Investigational Site #27

Rolling Hills Estates, California, United States

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Mylan Investigative Site #19

Sacramento, California, United States

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Mylan Investigative Site #20

San Diego, California, United States

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Mylan Investigative Site #21

San Jose, California, United States

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Mylan Investigative Site #101

Centennial, Colorado, United States

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Mylan Investigative Site #22

Centennial, Colorado, United States

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Mylan Investigative Site #23

Colorado Springs, Colorado, United States

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Mylan Investigative Site #24

Colorado Springs, Colorado, United States

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Mylan Investigative Site #25

Denver, Colorado, United States

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Mylan Investigative Site #26

Wheat Ridge, Colorado, United States

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Mylan Investigative Site #28

Coral Gables, Florida, United States

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Mylan Investigative Site #29

Gainesville, Florida, United States

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Mylan Investigative Site #30

Hialeah, Florida, United States

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Mylan Investigative Site #31

Largo, Florida, United States

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Mylan Investigative Site #32

Miami, Florida, United States

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Mylan Investigative Site #34

Miami, Florida, United States

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Mylan Investigative Site #33

Miami, Florida, United States

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Mylan Investigative Site #35

Miami, Florida, United States

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Mylan Investigative Site #36

New Port Richey, Florida, United States

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Mylan Investigative Site #37

Tallahassee, Florida, United States

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Mylan Investigative Site #38

Lawrenceville, Georgia, United States

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Mylan Investigative Site #39

River Forest, Illinois, United States

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Mylan Investigative Site #40

Shiloh, Illinois, United States

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Mylan Investigative Site #41

Lenexa, Kansas, United States

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Mylan Investigative Site #42

Bangor, Maine, United States

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Mylan Investigative Site #43

Baltimore, Maryland, United States

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Mylan Investigative Site #44

Bethesda, Maryland, United States

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Mylan Investigative Site #45

Wheaton, Maryland, United States

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Mylan Investigative Site #46

White Marsh, Maryland, United States

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Mylan Investigative Site #47

Fall River, Massachusetts, United States

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Mylan Investigative Site #48

North Dartmouth, Massachusetts, United States

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Mylan Investigative Site #49

North Dartmouth, Massachusetts, United States

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Mylan Investigative Site #50

Minneapolis, Minnesota, United States

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Mylan Investigative Site #51

Columbia, Missouri, United States

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Mylan Investigative Site #52

Rolla, Missouri, United States

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Mylan Investigative Site #53

St Louis, Missouri, United States

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Mylan Investigative Site #54

Warrensburg, Missouri, United States

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Mylan Investigative Site #55

Bozeman, Montana, United States

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Mylan Investigative Site #56

Missoula, Montana, United States

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Mylan Investigative Site #57

Bellevue, Nebraska, United States

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Mylan Investigative Site #58

Brick, New Jersey, United States

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Mylan Investigative Site #59

Ocean City, New Jersey, United States

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Mylan Investigative Site #60

Skillman, New Jersey, United States

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Mylan Investigative Site #61

New York, New York, United States

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Mylan Investigative Site #62

Asheville, North Carolina, United States

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Mylan Investigative Site #63

Charlotte, North Carolina, United States

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Mylan Investigative Site #64

Raleigh, North Carolina, United States

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Mylan Investigative Site #65

Canton, Ohio, United States

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Mylan Investigative Site #66

Cincinnati, Ohio, United States

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Mylan Investigative Site #67

Cincinnati, Ohio, United States

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Mylan Investigative Site #68

Sylvania, Ohio, United States

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Mylan Investigative Site #69

Toledo, Ohio, United States

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Mylan Investigative Site #70

Oklahoma City, Oklahoma, United States

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Mylan Investigative Site #71

Tulsa, Oklahoma, United States

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Mylan Investigative Site #72

Eugene, Oregon, United States

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Mylan Investigative Site #73

Lake Oswego, Oregon, United States

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Mylan Investigative Site #74

Medford, Oregon, United States

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Mylan Investigative Site #75

Portland, Oregon, United States

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Mylan Investigative Site #76

Jenkintown, Pennsylvania, United States

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Mylan Investigative Site #77

Pittsburgh, Pennsylvania, United States

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Mylan Investigative Site #78

Smithfield, Pennsylvania, United States

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Mylan Investigative Site #79

Providence, Rhode Island, United States

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Mylan Investigative Site #80

Warwick, Rhode Island, United States

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Mylan Investigative Site #81

North Charleston, South Carolina, United States

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Mylan Investigative Site #82

Spartanburg, South Carolina, United States

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Mylan Investigative Site #83

Spartanburg, South Carolina, United States

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Mylan Investigative Site #84

Boerne, Texas, United States

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Mylan Investigative Site #85

Dallas, Texas, United States

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Mylan Investigative Site #86

Dallas, Texas, United States

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Mylan Investigative Site #87

Dickinson, Texas, United States

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Mylan Investigative Site #88

El Paso, Texas, United States

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Mylan Investigative Site #89

New Braunfels, Texas, United States

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Mylan Investigative Site #90

San Antonio, Texas, United States

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Mylan Investigative Site #91

San Antonio, Texas, United States

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Mylan Investigative Site #92

Waco, Texas, United States

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Mylan Investigative Site #93

Provo, Utah, United States

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Mylan Investigative Site #94

South Burlington, Vermont, United States

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Mylan Investigative Site #95

Henrico, Virginia, United States

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Mylan Investigative Site #96

Seattle, Washington, United States

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Mylan Investigative Site #97

Spokane, Washington, United States

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Mylan Investigative Site #98

Tacoma, Washington, United States

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Mylan Investigative Site #99

Tacoma, Washington, United States

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Mylan Investigative Site #100

Greenfield, Wisconsin, United States

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Countries

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United States

References

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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.

Reference Type RESULT
PMID: 31634023 (View on PubMed)

Other Identifiers

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MGR001-3001

Identifier Type: -

Identifier Source: org_study_id

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