AsthmaPhase 3NCT02245672

MGR001 / Advair Diskus Local Equivalence Study in Asthma

A Phase 3 study testing MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) and Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) in people with Asthma, run by Mylan Pharma UK Ltd. at 101 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Asthma
What is being tested?: MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) and Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,128 participants
Where: 101 sitesUnited States
Study dates: Oct 2014to Jul 2015
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

101 sites in 1 country.

City, postcode or hospital

101 sites in 1 country

United States101 sites

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

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About this study

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

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
Being tested: MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate), Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate), Placebo
Keywords: Asthma, fluticasone, salmeterol, CRC749, Diskus, Advair, FEV1, MGR001
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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
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
PlaceboDrug
Placebo administered via the CRC749 and Diskus devices

Study groups in NCT02245672
Study group	Role	What they receive
MGR001	Experimental	MGR001 administered two times per day by inhalation throughout the study Receives: 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 Receives: 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 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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.
Measured: 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]
Measured: Day 1 and Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2014Jul 2015

First posted19 Sep 2014 (estimated)
Study startOct 2014
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AsthmaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,128 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02245672
Sponsor's protocol ID: MGR001-3001
Status last verified: Feb 2022
First submitted: 15 Sep 2014
Last updated: 24 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 31634023

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02245672
Acronym / sponsor ID: MGR001-3001
Conditions: Asthma
Keywords: Asthma, fluticasone, salmeterol, CRC749, Diskus, Advair, FEV1, MGR001
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,128 participants (actual)
Lead sponsor: Mylan Pharma UK Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2014
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 19 Sep 2014 (estimated)
Results: Posted 12 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
MGR001	Experimental	Drug: MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)MGR001 administered two times per day by inhalation throughout the study
Advair Diskus	Active comparator	Drug: Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)Advair Diskus administered two times per day by inhalation throughout the study
Placebo	Placebo comparator	Drug: PlaceboPlacebo for Advair Diskus and MGR001 administered two times per day by inhalation throughout the study

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Drug	MGR001
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	Drug	Advair Diskus
PlaceboPlacebo administered via the CRC749 and Diskus devices	Drug	Placebo

Primary outcome

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
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
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.
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]

Results and safety

Results posted to the registry on 12 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MGR001	512	499
Advair Diskus	513	500
Placebo	103	98

Primary outcome: 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. Least squares mean (Standard Error). Unit: L*hr

Measure	MGR001 n = 508	Advair Diskus n = 510	Placebo n = 102
Value	3.9534 (0.1609)	3.4964 (0.1595)	0.8191 (0.3477)

MGR001 vs Placebo: p <0.0001, ANCOVA
Advair Diskus vs Placebo: p <0.0001, ANCOVA

Population analysed: Full Analysis Set

Primary outcome: 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. Least squares mean (Standard Error). Unit: L*hr

Measure	MGR001 n = 497	Advair Diskus n = 494	Placebo n = 94
Value	3.9734 (0.1704)	3.5411 (0.1593)	0.8400 (0.2983)

MGR001 vs Advair Diskus: Ratio (MGR001/Advair Diskus): 1.120 (90% CI 1.016 to 1.237)

Population analysed: Per Protocol Set

Primary outcome: FEV1 Trough Value (Assay Sensitivity)

Time frame: Day 1 and Day 29. Least squares mean (Standard Error). Unit: L

Measure	MGR001 n = 504	Advair Diskus n = 505	Placebo n = 100
Value	0.2927 (0.0162)	0.2720 (0.0161)	0.0575 (0.0353)

MGR001 vs Placebo: p <0.0001, ANCOVA
Advair Diskus vs Placebo: p <0.0001, ANCOVA

Population analysed: Full Analysis Set

Primary outcome: FEV1 Trough Value (Bioequivalence)

Time frame: Day 1 and Day 29. Least squares mean (Standard Error). Unit: L

Measure	MGR001 n = 498	Advair Diskus n = 497	Placebo n = 99
Value	0.2911 (0.0163)	0.2728 (0.0162)	0.0574 (0.0355)

MGR001 vs Advair Diskus: Ratio (MGR001/Advair Diskus): 1.069 (90% CI 0.938 to 1.220)

Population analysed: Per Protocol Set

Adverse events

Time frame: Adverse events (AEs) were collected from the signing of the ICF but are reported from Day 1 to 30 days after the last dose of double-blind study medication.. Other adverse events reported at 0.2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MGR001	0 of 512 (0%)	39 of 512 (7.6%)	0 of 512
Advair Diskus	0 of 512 (0%)	51 of 512 (10%)	0 of 512
Placebo	0 of 103 (0%)	10 of 103 (9.7%)	0 of 103

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31634023Ng 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dik WH Ng, PhD study director

Mylan Pharma UK Ltd.

101 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 101 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02245672, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.