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MGR001 / Advair Diskus Local Equivalence Study in Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)
Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)
Placebo
Sponsored by
Mylan Pharma UK Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, fluticasone, salmeterol, CRC749, Diskus, Advair, FEV1, MGR001

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mylan Investigative Site #1
  • Mylan Investigative Site #2
  • Mylan Investigative Site #3
  • Mylan Investigative Site #4
  • Mylan Investigative Site #5
  • Mylan Investigative Site #6
  • Mylan Investigative Site #7
  • Mylan Investigative Site #8
  • Mylan Investigative Site #9
  • Mylan Investigative Site #10
  • Mylan Investigative Site #11
  • Mylan Investigative Site #12
  • Mylan Investigative Site #13
  • Mylan Investigative Site #14
  • Mylan Investigative Site #15
  • Mylan Investigative Site #16
  • Mylan Investigative Site #17
  • Mylan Investigative Site #18
  • Mylan Investigational Site #27
  • Mylan Investigative Site #19
  • Mylan Investigative Site #20
  • Mylan Investigative Site #21
  • Mylan Investigative Site #101
  • Mylan Investigative Site #22
  • Mylan Investigative Site #23
  • Mylan Investigative Site #24
  • Mylan Investigative Site #25
  • Mylan Investigative Site #26
  • Mylan Investigative Site #28
  • Mylan Investigative Site #29
  • Mylan Investigative Site #30
  • Mylan Investigative Site #31
  • Mylan Investigative Site #32
  • Mylan Investigative Site #34
  • Mylan Investigative Site #33
  • Mylan Investigative Site #35
  • Mylan Investigative Site #36
  • Mylan Investigative Site #37
  • Mylan Investigative Site #38
  • Mylan Investigative Site #39
  • Mylan Investigative Site #40
  • Mylan Investigative Site #41
  • Mylan Investigative Site #42
  • Mylan Investigative Site #43
  • Mylan Investigative Site #44
  • Mylan Investigative Site #45
  • Mylan Investigative Site #46
  • Mylan Investigative Site #47
  • Mylan Investigative Site #48
  • Mylan Investigative Site #49
  • Mylan Investigative Site #50
  • Mylan Investigative Site #51
  • Mylan Investigative Site #52
  • Mylan Investigative Site #53
  • Mylan Investigative Site #54
  • Mylan Investigative Site #55
  • Mylan Investigative Site #56
  • Mylan Investigative Site #57
  • Mylan Investigative Site #58
  • Mylan Investigative Site #59
  • Mylan Investigative Site #60
  • Mylan Investigative Site #61
  • Mylan Investigative Site #62
  • Mylan Investigative Site #63
  • Mylan Investigative Site #64
  • Mylan Investigative Site #65
  • Mylan Investigative Site #66
  • Mylan Investigative Site #67
  • Mylan Investigative Site #68
  • Mylan Investigative Site #69
  • Mylan Investigative Site #70
  • Mylan Investigative Site #71
  • Mylan Investigative Site #72
  • Mylan Investigative Site #73
  • Mylan Investigative Site #74
  • Mylan Investigative Site #75
  • Mylan Investigative Site #76
  • Mylan Investigative Site #77
  • Mylan Investigative Site #78
  • Mylan Investigative Site #79
  • Mylan Investigative Site #80
  • Mylan Investigative Site #81
  • Mylan Investigative Site #82
  • Mylan Investigative Site #83
  • Mylan Investigative Site #84
  • Mylan Investigative Site #85
  • Mylan Investigative Site #86
  • Mylan Investigative Site #87
  • Mylan Investigative Site #88
  • Mylan Investigative Site #89
  • Mylan Investigative Site #90
  • Mylan Investigative Site #91
  • Mylan Investigative Site #92
  • Mylan Investigative Site #93
  • Mylan Investigative Site #94
  • Mylan Investigative Site #95
  • Mylan Investigative Site #96
  • Mylan Investigative Site #97
  • Mylan Investigative Site #98
  • Mylan Investigative Site #99
  • Mylan Investigative Site #100

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

MGR001

Advair Diskus

Placebo

Arm Description

MGR001 administered two times per day by inhalation throughout the study

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

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

Outcomes

Primary Outcome Measures

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
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
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.
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]

Secondary Outcome Measures

Full Information

First Posted
September 15, 2014
Last Updated
February 22, 2022
Sponsor
Mylan Pharma UK Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02245672
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mylan Pharma UK Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, fluticasone, salmeterol, CRC749, Diskus, Advair, FEV1, MGR001

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MGR001
Arm Type
Experimental
Arm Description
MGR001 administered two times per day by inhalation throughout the study
Arm Title
Advair Diskus
Arm Type
Active Comparator
Arm Description
Advair Diskus administered two times per day by inhalation throughout the study
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study
Intervention Type
Drug
Intervention Name(s)
MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)
Intervention Description
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device
Intervention Type
Drug
Intervention Name(s)
Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)
Intervention Description
Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo administered via the CRC749 and Diskus devices
Primary Outcome Measure Information:
Title
Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity)
Description
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
Time Frame
0-12 hours after dosing on Day 1
Title
Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence)
Description
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
Time Frame
0-12 hours after dosing on Day 1
Title
FEV1 Trough Value (Assay Sensitivity)
Description
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.
Time Frame
Day 1 and Day 29
Title
FEV1 Trough Value (Bioequivalence)
Description
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]
Time Frame
Day 1 and Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dik WH Ng, PhD
Organizational Affiliation
Mylan Pharma UK Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Mylan Investigative Site #1
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Mylan Investigative Site #2
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Mylan Investigative Site #3
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Mylan Investigative Site #4
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Mylan Investigative Site #5
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Mylan Investigative Site #6
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Mylan Investigative Site #7
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Mylan Investigative Site #8
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
Mylan Investigative Site #9
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Mylan Investigative Site #10
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Mylan Investigative Site #11
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Mylan Investigative Site #12
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Mylan Investigative Site #13
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Mylan Investigative Site #14
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Mylan Investigative Site #15
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Mylan Investigative Site #16
City
Napa
State/Province
California
ZIP/Postal Code
94558
Country
United States
Facility Name
Mylan Investigative Site #17
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Mylan Investigative Site #18
City
Riverside
State/Province
California
ZIP/Postal Code
92506
Country
United States
Facility Name
Mylan Investigational Site #27
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Mylan Investigative Site #19
City
Sacramento
State/Province
California
ZIP/Postal Code
95842
Country
United States
Facility Name
Mylan Investigative Site #20
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Mylan Investigative Site #21
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Facility Name
Mylan Investigative Site #101
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Mylan Investigative Site #22
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Mylan Investigative Site #23
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Mylan Investigative Site #24
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Mylan Investigative Site #25
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Mylan Investigative Site #26
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Mylan Investigative Site #28
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Mylan Investigative Site #29
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
Mylan Investigative Site #30
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Mylan Investigative Site #31
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Mylan Investigative Site #32
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Mylan Investigative Site #34
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
Country
United States
Facility Name
Mylan Investigative Site #33
City
Miami
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Mylan Investigative Site #35
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Mylan Investigative Site #36
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34653
Country
United States
Facility Name
Mylan Investigative Site #37
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Mylan Investigative Site #38
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30046
Country
United States
Facility Name
Mylan Investigative Site #39
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Facility Name
Mylan Investigative Site #40
City
Shiloh
State/Province
Illinois
ZIP/Postal Code
62269
Country
United States
Facility Name
Mylan Investigative Site #41
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Mylan Investigative Site #42
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Mylan Investigative Site #43
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Mylan Investigative Site #44
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Mylan Investigative Site #45
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Mylan Investigative Site #46
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Facility Name
Mylan Investigative Site #47
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Mylan Investigative Site #48
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Mylan Investigative Site #49
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Mylan Investigative Site #50
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Mylan Investigative Site #51
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Mylan Investigative Site #52
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Mylan Investigative Site #53
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mylan Investigative Site #54
City
Warrensburg
State/Province
Missouri
ZIP/Postal Code
64093
Country
United States
Facility Name
Mylan Investigative Site #55
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Mylan Investigative Site #56
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Facility Name
Mylan Investigative Site #57
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123-4303
Country
United States
Facility Name
Mylan Investigative Site #58
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Facility Name
Mylan Investigative Site #59
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
Mylan Investigative Site #60
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
Mylan Investigative Site #61
City
New York
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
Mylan Investigative Site #62
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Mylan Investigative Site #63
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Mylan Investigative Site #64
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Mylan Investigative Site #65
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Mylan Investigative Site #66
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Mylan Investigative Site #67
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Mylan Investigative Site #68
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Mylan Investigative Site #69
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43617
Country
United States
Facility Name
Mylan Investigative Site #70
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Mylan Investigative Site #71
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-8303
Country
United States
Facility Name
Mylan Investigative Site #72
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Mylan Investigative Site #73
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Mylan Investigative Site #74
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Mylan Investigative Site #75
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Facility Name
Mylan Investigative Site #76
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Mylan Investigative Site #77
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Facility Name
Mylan Investigative Site #78
City
Smithfield
State/Province
Pennsylvania
ZIP/Postal Code
15478
Country
United States
Facility Name
Mylan Investigative Site #79
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Mylan Investigative Site #80
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Mylan Investigative Site #81
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29420
Country
United States
Facility Name
Mylan Investigative Site #82
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Mylan Investigative Site #83
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Mylan Investigative Site #84
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Facility Name
Mylan Investigative Site #85
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Mylan Investigative Site #86
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Mylan Investigative Site #87
City
Dickinson
State/Province
Texas
ZIP/Postal Code
77539
Country
United States
Facility Name
Mylan Investigative Site #88
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Mylan Investigative Site #89
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Mylan Investigative Site #90
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Mylan Investigative Site #91
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Mylan Investigative Site #92
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Mylan Investigative Site #93
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Mylan Investigative Site #94
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
Mylan Investigative Site #95
City
Henrico
State/Province
Virginia
ZIP/Postal Code
23233
Country
United States
Facility Name
Mylan Investigative Site #96
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States
Facility Name
Mylan Investigative Site #97
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Mylan Investigative Site #98
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Mylan Investigative Site #99
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Mylan Investigative Site #100
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31634023
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.
Results Reference
result

Learn more about this trial

MGR001 / Advair Diskus Local Equivalence Study in Asthma

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