MGR001 / Advair Diskus Local Equivalence Study in Asthma

NCT02245672 | Completed Phase 3 Results

• 1 other identifier: MGR001-3001
• Study Type: interventional
• Target: 1,128
• Locations: 1 country
• Sites: 101

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

Conditions

Asthma

Keywords

Asthma; fluticasone; salmeterol; CRC749; Diskus; Advair; FEV1; MGR001

Outcome Measures

Primary Outcomes (4)

• Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity)

  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

  0-12 hours after dosing on Day 1

• Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence)

  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

  0-12 hours after dosing on Day 1

• FEV1 Trough Value (Assay Sensitivity)

  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.

  Day 1 and Day 29

• FEV1 Trough Value (Bioequivalence)

  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 \[prebronchodilator FEV1 measured at a run-in visit and the mean of 2 predose FEV1 measures taken at Day 1\]

  Day 1 and Day 29

Study Arms (3)

MGR001

EXPERIMENTAL

MGR001 administered two times per day by inhalation throughout the study

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

Advair Diskus

ACTIVE COMPARATOR

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

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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

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

MGR001

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

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

Advair Diskus

Placebo DRUG

Placebo administered via the CRC749 and Diskus devices

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mylan Pharma UK Ltd.: lead

Study Sites (101)

Mylan Investigative Site #1

Birmingham, Alabama, 35209, United States

Location

Mylan Investigative Site #2

Little Rock, Arkansas, 72205, United States

Location

Mylan Investigative Site #3

Anaheim, California, 92801, United States

Location

Mylan Investigative Site #4

Bakersfield, California, 93301, United States

Location

Mylan Investigative Site #5

Burbank, California, 91505, United States

Location

Mylan Investigative Site #6

Costa Mesa, California, 92626, United States

Location

Mylan Investigative Site #7

Encinitas, California, 92024, United States

Location

Mylan Investigative Site #8

Fresno, California, 93720, United States

Location

Mylan Investigative Site #9

Fullerton, California, 92835, United States

Location

Mylan Investigative Site #10

Huntington Beach, California, 92647, United States

Location

Mylan Investigative Site #11

Huntington Beach, California, 92647, United States

Location

Mylan Investigative Site #12

Los Angeles, California, 90025, United States

Location

Mylan Investigative Site #13

Los Angeles, California, 90025, United States

Location

Mylan Investigative Site #14

Los Angeles, California, 90048, United States

Location

Mylan Investigative Site #15

Mission Viejo, California, 92691, United States

Location

Mylan Investigative Site #16

Napa, California, 94558, United States

Location

Mylan Investigative Site #17

Orange, California, 92868, United States

Location

Mylan Investigative Site #18

Riverside, California, 92506, United States

Location

Mylan Investigational Site #27

Rolling Hills Estates, California, 90274, United States

Location

Mylan Investigative Site #19

Sacramento, California, 95842, United States

Location

Mylan Investigative Site #20

San Diego, California, 92123, United States

Location

Mylan Investigative Site #21

San Jose, California, 95117, United States

Location

Mylan Investigative Site #101

Centennial, Colorado, 80112, United States

Location

Mylan Investigative Site #22

Centennial, Colorado, 80112, United States

Location

Mylan Investigative Site #23

Colorado Springs, Colorado, 80907, United States

Location

Mylan Investigative Site #24

Colorado Springs, Colorado, 80907, United States

Location

Mylan Investigative Site #25

Denver, Colorado, 80230, United States

Location

Mylan Investigative Site #26

Wheat Ridge, Colorado, 80033, United States

Location

Mylan Investigative Site #28

Coral Gables, Florida, 33134, United States

Location

Mylan Investigative Site #29

Gainesville, Florida, 32607, United States

Location

Mylan Investigative Site #30

Hialeah, Florida, 33012, United States

Location

Mylan Investigative Site #31

Largo, Florida, 33770, United States

Location

Mylan Investigative Site #32

Miami, Florida, 33015, United States

Location

Mylan Investigative Site #34

Miami, Florida, 33133, United States

Location

Mylan Investigative Site #33

Miami, Florida, 33134, United States

Location

Mylan Investigative Site #35

Miami, Florida, 33155, United States

Location

Mylan Investigative Site #36

New Port Richey, Florida, 34653, United States

Location

Mylan Investigative Site #37

Tallahassee, Florida, 32308, United States

Location

Mylan Investigative Site #38

Lawrenceville, Georgia, 30046, United States

Location

Mylan Investigative Site #39

River Forest, Illinois, 60305, United States

Location

Mylan Investigative Site #40

Shiloh, Illinois, 62269, United States

Location

Mylan Investigative Site #41

Lenexa, Kansas, 66219, United States

Location

Mylan Investigative Site #42

Bangor, Maine, 04401, United States

Location

Mylan Investigative Site #43

Baltimore, Maryland, 21236, United States

Location

Mylan Investigative Site #44

Bethesda, Maryland, 20814, United States

Location

Mylan Investigative Site #45

Wheaton, Maryland, 20902, United States

Location

Mylan Investigative Site #46

White Marsh, Maryland, 21162, United States

Location

Mylan Investigative Site #47

Fall River, Massachusetts, 02720, United States

Location

Mylan Investigative Site #48

North Dartmouth, Massachusetts, 02747, United States

Location

Mylan Investigative Site #49

North Dartmouth, Massachusetts, 02747, United States

Location

Mylan Investigative Site #50

Minneapolis, Minnesota, 55402, United States

Location

Mylan Investigative Site #51

Columbia, Missouri, 65203, United States

Location

Mylan Investigative Site #52

Rolla, Missouri, 65401, United States

Location

Mylan Investigative Site #53

St Louis, Missouri, 63141, United States

Location

Mylan Investigative Site #54

Warrensburg, Missouri, 64093, United States

Location

Mylan Investigative Site #55

Bozeman, Montana, 59718, United States

Location

Mylan Investigative Site #56

Missoula, Montana, 59808, United States

Location

Mylan Investigative Site #57

Bellevue, Nebraska, 68123-4303, United States

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Mylan Investigative Site #58

Brick, New Jersey, 08724, United States

Location

Mylan Investigative Site #59

Ocean City, New Jersey, 07712, United States

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Mylan Investigative Site #60

Skillman, New Jersey, 08558, United States

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Mylan Investigative Site #61

New York, New York, 11570, United States

Location

Mylan Investigative Site #62

Asheville, North Carolina, 28801, United States

Location

Mylan Investigative Site #63

Charlotte, North Carolina, 28207, United States

Location

Mylan Investigative Site #64

Raleigh, North Carolina, 27607, United States

Location

Mylan Investigative Site #65

Canton, Ohio, 44718, United States

Location

Mylan Investigative Site #66

Cincinnati, Ohio, 45231, United States

Location

Mylan Investigative Site #67

Cincinnati, Ohio, 45242, United States

Location

Mylan Investigative Site #68

Sylvania, Ohio, 43560, United States

Location

Mylan Investigative Site #69

Toledo, Ohio, 43617, United States

Location

Mylan Investigative Site #70

Oklahoma City, Oklahoma, 73112, United States

Location

Mylan Investigative Site #71

Tulsa, Oklahoma, 74136-8303, United States

Location

Mylan Investigative Site #72

Eugene, Oregon, 97401, United States

Location

Mylan Investigative Site #73

Lake Oswego, Oregon, 97035, United States

Location

Mylan Investigative Site #74

Medford, Oregon, 97504, United States

Location

Mylan Investigative Site #75

Portland, Oregon, 97202, United States

Location

Mylan Investigative Site #76

Jenkintown, Pennsylvania, 19046, United States

Location

Mylan Investigative Site #77

Pittsburgh, Pennsylvania, 15243, United States

Location

Mylan Investigative Site #78

Smithfield, Pennsylvania, 15478, United States

Location

Mylan Investigative Site #79

Providence, Rhode Island, 02906, United States

Location

Mylan Investigative Site #80

Warwick, Rhode Island, 02886, United States

Location

Mylan Investigative Site #81

North Charleston, South Carolina, 29420, United States

Location

Mylan Investigative Site #82

Spartanburg, South Carolina, 29303, United States

Location

Mylan Investigative Site #83

Spartanburg, South Carolina, 29303, United States

Location

Mylan Investigative Site #84

Boerne, Texas, 78006, United States

Location

Mylan Investigative Site #85

Dallas, Texas, 75231, United States

Location

Mylan Investigative Site #86

Dallas, Texas, 75231, United States

Location

Mylan Investigative Site #87

Dickinson, Texas, 77539, United States

Location

Mylan Investigative Site #88

El Paso, Texas, 79903, United States

Location

Mylan Investigative Site #89

New Braunfels, Texas, 78130, United States

Location

Mylan Investigative Site #90

San Antonio, Texas, 78229, United States

Location

Mylan Investigative Site #91

San Antonio, Texas, 78229, United States

Location

Mylan Investigative Site #92

Waco, Texas, 76712, United States

Location

Mylan Investigative Site #93

Provo, Utah, 84604, United States

Location

Mylan Investigative Site #94

South Burlington, Vermont, 05403, United States

Location

Mylan Investigative Site #95

Henrico, Virginia, 23233, United States

Location

Mylan Investigative Site #96

Seattle, Washington, 98115, United States

Location

Mylan Investigative Site #97

Spokane, Washington, 99204, United States

Location

Mylan Investigative Site #98

Tacoma, Washington, 98405, United States

Location

Mylan Investigative Site #99

Tacoma, Washington, 98405, United States

Location

Mylan Investigative Site #100

Greenfield, Wisconsin, 53228, United States

Location

Related Publications (1)

• 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.

  PMID: 31634023 RESULT

MeSH Terms

Conditions

Asthma

Interventions

Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dik Ng, PhD
• Organization: Mylan Pharma UK Ltd

dik.ng@mylan.co.uk

+44-7467-941703

Study Officials

• Dik WH Ng, PhD

  Mylan Pharma UK Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2014
• First Posted: September 19, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: February 24, 2022
• Results First Posted: January 12, 2021

Record last verified: 2022-02

Locations

US (101)