MGR001 / Advair Diskus Local Equivalence Study in Asthma

February 22, 2022 updated by: Mylan Pharma UK Ltd.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Mylan Investigative Site #1
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Mylan Investigative Site #2
    • California
      • Anaheim, California, United States, 92801
        • Mylan Investigative Site #3
      • Bakersfield, California, United States, 93301
        • Mylan Investigative Site #4
      • Burbank, California, United States, 91505
        • Mylan Investigative Site #5
      • Costa Mesa, California, United States, 92626
        • Mylan Investigative Site #6
      • Encinitas, California, United States, 92024
        • Mylan Investigative Site #7
      • Fresno, California, United States, 93720
        • Mylan Investigative Site #8
      • Fullerton, California, United States, 92835
        • Mylan Investigative Site #9
      • Huntington Beach, California, United States, 92647
        • Mylan Investigative Site #10
      • Huntington Beach, California, United States, 92647
        • Mylan Investigative Site #11
      • Los Angeles, California, United States, 90025
        • Mylan Investigative Site #12
      • Los Angeles, California, United States, 90025
        • Mylan Investigative Site #13
      • Los Angeles, California, United States, 90048
        • Mylan Investigative Site #14
      • Mission Viejo, California, United States, 92691
        • Mylan Investigative Site #15
      • Napa, California, United States, 94558
        • Mylan Investigative Site #16
      • Orange, California, United States, 92868
        • Mylan Investigative Site #17
      • Riverside, California, United States, 92506
        • Mylan Investigative Site #18
      • Rolling Hills Estates, California, United States, 90274
        • Mylan Investigational Site #27
      • Sacramento, California, United States, 95842
        • Mylan Investigative Site #19
      • San Diego, California, United States, 92123
        • Mylan Investigative Site #20
      • San Jose, California, United States, 95117
        • Mylan Investigative Site #21
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Mylan Investigative Site #101
      • Centennial, Colorado, United States, 80112
        • Mylan Investigative Site #22
      • Colorado Springs, Colorado, United States, 80907
        • Mylan Investigative Site #23
      • Colorado Springs, Colorado, United States, 80907
        • Mylan Investigative Site #24
      • Denver, Colorado, United States, 80230
        • Mylan Investigative Site #25
      • Wheat Ridge, Colorado, United States, 80033
        • Mylan Investigative Site #26
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Mylan Investigative Site #28
      • Gainesville, Florida, United States, 32607
        • Mylan Investigative Site #29
      • Hialeah, Florida, United States, 33012
        • Mylan Investigative Site #30
      • Largo, Florida, United States, 33770
        • Mylan Investigative Site #31
      • Miami, Florida, United States, 33015
        • Mylan Investigative Site #32
      • Miami, Florida, United States, 33133
        • Mylan Investigative Site #34
      • Miami, Florida, United States, 33134
        • Mylan Investigative Site #33
      • Miami, Florida, United States, 33155
        • Mylan Investigative Site #35
      • New Port Richey, Florida, United States, 34653
        • Mylan Investigative Site #36
      • Tallahassee, Florida, United States, 32308
        • Mylan Investigative Site #37
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Mylan Investigative Site #38
    • Illinois
      • River Forest, Illinois, United States, 60305
        • Mylan Investigative Site #39
      • Shiloh, Illinois, United States, 62269
        • Mylan Investigative Site #40
    • Kansas
      • Lenexa, Kansas, United States, 66219
        • Mylan Investigative Site #41
    • Maine
      • Bangor, Maine, United States, 04401
        • Mylan Investigative Site #42
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Mylan Investigative Site #43
      • Bethesda, Maryland, United States, 20814
        • Mylan Investigative Site #44
      • Wheaton, Maryland, United States, 20902
        • Mylan Investigative Site #45
      • White Marsh, Maryland, United States, 21162
        • Mylan Investigative Site #46
    • Massachusetts
      • Fall River, Massachusetts, United States, 02720
        • Mylan Investigative Site #47
      • North Dartmouth, Massachusetts, United States, 02747
        • Mylan Investigative Site #48
      • North Dartmouth, Massachusetts, United States, 02747
        • Mylan Investigative Site #49
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Mylan Investigative Site #50
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Mylan Investigative Site #51
      • Rolla, Missouri, United States, 65401
        • Mylan Investigative Site #52
      • Saint Louis, Missouri, United States, 63141
        • Mylan Investigative Site #53
      • Warrensburg, Missouri, United States, 64093
        • Mylan Investigative Site #54
    • Montana
      • Bozeman, Montana, United States, 59718
        • Mylan Investigative Site #55
      • Missoula, Montana, United States, 59808
        • Mylan Investigative Site #56
    • Nebraska
      • Bellevue, Nebraska, United States, 68123-4303
        • Mylan Investigative Site #57
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Mylan Investigative Site #58
      • Ocean City, New Jersey, United States, 07712
        • Mylan Investigative Site #59
      • Skillman, New Jersey, United States, 08558
        • Mylan Investigative Site #60
    • New York
      • New York, New York, United States, 11570
        • Mylan Investigative Site #61
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Mylan Investigative Site #62
      • Charlotte, North Carolina, United States, 28207
        • Mylan Investigative Site #63
      • Raleigh, North Carolina, United States, 27607
        • Mylan Investigative Site #64
    • Ohio
      • Canton, Ohio, United States, 44718
        • Mylan Investigative Site #65
      • Cincinnati, Ohio, United States, 45231
        • Mylan Investigative Site #66
      • Cincinnati, Ohio, United States, 45242
        • Mylan Investigative Site #67
      • Sylvania, Ohio, United States, 43560
        • Mylan Investigative Site #68
      • Toledo, Ohio, United States, 43617
        • Mylan Investigative Site #69
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Mylan Investigative Site #70
      • Tulsa, Oklahoma, United States, 74136-8303
        • Mylan Investigative Site #71
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Mylan Investigative Site #72
      • Lake Oswego, Oregon, United States, 97035
        • Mylan Investigative Site #73
      • Medford, Oregon, United States, 97504
        • Mylan Investigative Site #74
      • Portland, Oregon, United States, 97202
        • Mylan Investigative Site #75
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Mylan Investigative Site #76
      • Pittsburgh, Pennsylvania, United States, 15243
        • Mylan Investigative Site #77
      • Smithfield, Pennsylvania, United States, 15478
        • Mylan Investigative Site #78
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Mylan Investigative Site #79
      • Warwick, Rhode Island, United States, 02886
        • Mylan Investigative Site #80
    • South Carolina
      • North Charleston, South Carolina, United States, 29420
        • Mylan Investigative Site #81
      • Spartanburg, South Carolina, United States, 29303
        • Mylan Investigative Site #82
      • Spartanburg, South Carolina, United States, 29303
        • Mylan Investigative Site #83
    • Texas
      • Boerne, Texas, United States, 78006
        • Mylan Investigative Site #84
      • Dallas, Texas, United States, 75231
        • Mylan Investigative Site #85
      • Dallas, Texas, United States, 75231
        • Mylan Investigative Site #86
      • Dickinson, Texas, United States, 77539
        • Mylan Investigative Site #87
      • El Paso, Texas, United States, 79903
        • Mylan Investigative Site #88
      • New Braunfels, Texas, United States, 78130
        • Mylan Investigative Site #89
      • San Antonio, Texas, United States, 78229
        • Mylan Investigative Site #90
      • San Antonio, Texas, United States, 78229
        • Mylan Investigative Site #91
      • Waco, Texas, United States, 76712
        • Mylan Investigative Site #92
    • Utah
      • Provo, Utah, United States, 84604
        • Mylan Investigative Site #93
    • Vermont
      • South Burlington, Vermont, United States, 05403
        • Mylan Investigative Site #94
    • Virginia
      • Henrico, Virginia, United States, 23233
        • Mylan Investigative Site #95
    • Washington
      • Seattle, Washington, United States, 98115
        • Mylan Investigative Site #96
      • Spokane, Washington, United States, 99204
        • Mylan Investigative Site #97
      • Tacoma, Washington, United States, 98405
        • Mylan Investigative Site #98
      • Tacoma, Washington, United States, 98405
        • Mylan Investigative Site #99
    • Wisconsin
      • Greenfield, Wisconsin, United States, 53228
        • Mylan Investigative Site #100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MGR001
MGR001 administered two times per day by inhalation throughout the study
Drug: 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
Active Comparator: Advair Diskus
Advair Diskus administered two times per day by inhalation throughout the study
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
Placebo Comparator: Placebo
Placebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study
Drug: Placebo
Placebo administered via the CRC749 and Diskus devices

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Assay Sensitivity)
Time Frame: 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
0-12 hours after dosing on Day 1
Forced Exhaled Volume in 1 Sec (FEV1) Area Under the Effect Curve on Day 1 (Bioequivalence)
Time Frame: 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
0-12 hours after dosing on Day 1
FEV1 Trough Value (Assay Sensitivity)
Time Frame: 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.
Day 1 and Day 29
FEV1 Trough Value (Bioequivalence)
Time Frame: 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]
Day 1 and Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mylan Pharma UK Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Dik WH Ng, PhD, Mylan Pharma UK Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 17, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MGR001-3001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

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Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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