Asthma Clinical Trial
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
| NCT number | NCT02245672 |
| Other study ID # | MGR001-3001 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | October 2014 |
| Est. completion date | July 2015 |
| Verified date | February 2022 |
| Source | Viatris Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine whether MGR001 is equivalent to Advair Diskus when administered by inhalation in adult asthma patients
| Status | Completed |
| Enrollment | 1128 |
| Est. completion date | July 2015 |
| Est. primary completion date | July 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Mylan Investigative Site #3 | Anaheim | California |
| United States | Mylan Investigative Site #62 | Asheville | North Carolina |
| United States | Mylan Investigative Site #4 | Bakersfield | California |
| United States | Mylan Investigative Site #43 | Baltimore | Maryland |
| United States | Mylan Investigative Site #42 | Bangor | Maine |
| United States | Mylan Investigative Site #57 | Bellevue | Nebraska |
| United States | Mylan Investigative Site #44 | Bethesda | Maryland |
| United States | Mylan Investigative Site #1 | Birmingham | Alabama |
| United States | Mylan Investigative Site #84 | Boerne | Texas |
| United States | Mylan Investigative Site #55 | Bozeman | Montana |
| United States | Mylan Investigative Site #58 | Brick | New Jersey |
| United States | Mylan Investigative Site #5 | Burbank | California |
| United States | Mylan Investigative Site #65 | Canton | Ohio |
| United States | Mylan Investigative Site #101 | Centennial | Colorado |
| United States | Mylan Investigative Site #22 | Centennial | Colorado |
| United States | Mylan Investigative Site #63 | Charlotte | North Carolina |
| United States | Mylan Investigative Site #66 | Cincinnati | Ohio |
| United States | Mylan Investigative Site #67 | Cincinnati | Ohio |
| United States | Mylan Investigative Site #23 | Colorado Springs | Colorado |
| United States | Mylan Investigative Site #24 | Colorado Springs | Colorado |
| United States | Mylan Investigative Site #51 | Columbia | Missouri |
| United States | Mylan Investigative Site #28 | Coral Gables | Florida |
| United States | Mylan Investigative Site #6 | Costa Mesa | California |
| United States | Mylan Investigative Site #85 | Dallas | Texas |
| United States | Mylan Investigative Site #86 | Dallas | Texas |
| United States | Mylan Investigative Site #25 | Denver | Colorado |
| United States | Mylan Investigative Site #87 | Dickinson | Texas |
| United States | Mylan Investigative Site #88 | El Paso | Texas |
| United States | Mylan Investigative Site #7 | Encinitas | California |
| United States | Mylan Investigative Site #72 | Eugene | Oregon |
| United States | Mylan Investigative Site #47 | Fall River | Massachusetts |
| United States | Mylan Investigative Site #8 | Fresno | California |
| United States | Mylan Investigative Site #9 | Fullerton | California |
| United States | Mylan Investigative Site #29 | Gainesville | Florida |
| United States | Mylan Investigative Site #100 | Greenfield | Wisconsin |
| United States | Mylan Investigative Site #95 | Henrico | Virginia |
| United States | Mylan Investigative Site #30 | Hialeah | Florida |
| United States | Mylan Investigative Site #10 | Huntington Beach | California |
| United States | Mylan Investigative Site #11 | Huntington Beach | California |
| United States | Mylan Investigative Site #76 | Jenkintown | Pennsylvania |
| United States | Mylan Investigative Site #73 | Lake Oswego | Oregon |
| United States | Mylan Investigative Site #31 | Largo | Florida |
| United States | Mylan Investigative Site #38 | Lawrenceville | Georgia |
| United States | Mylan Investigative Site #41 | Lenexa | Kansas |
| United States | Mylan Investigative Site #2 | Little Rock | Arkansas |
| United States | Mylan Investigative Site #12 | Los Angeles | California |
| United States | Mylan Investigative Site #13 | Los Angeles | California |
| United States | Mylan Investigative Site #14 | Los Angeles | California |
| United States | Mylan Investigative Site #74 | Medford | Oregon |
| United States | Mylan Investigative Site #32 | Miami | Florida |
| United States | Mylan Investigative Site #33 | Miami | Florida |
| United States | Mylan Investigative Site #34 | Miami | Florida |
| United States | Mylan Investigative Site #35 | Miami | Florida |
| United States | Mylan Investigative Site #50 | Minneapolis | Minnesota |
| United States | Mylan Investigative Site #15 | Mission Viejo | California |
| United States | Mylan Investigative Site #56 | Missoula | Montana |
| United States | Mylan Investigative Site #16 | Napa | California |
| United States | Mylan Investigative Site #89 | New Braunfels | Texas |
| United States | Mylan Investigative Site #36 | New Port Richey | Florida |
| United States | Mylan Investigative Site #61 | New York | New York |
| United States | Mylan Investigative Site #81 | North Charleston | South Carolina |
| United States | Mylan Investigative Site #48 | North Dartmouth | Massachusetts |
| United States | Mylan Investigative Site #49 | North Dartmouth | Massachusetts |
| United States | Mylan Investigative Site #59 | Ocean City | New Jersey |
| United States | Mylan Investigative Site #70 | Oklahoma City | Oklahoma |
| United States | Mylan Investigative Site #17 | Orange | California |
| United States | Mylan Investigative Site #77 | Pittsburgh | Pennsylvania |
| United States | Mylan Investigative Site #75 | Portland | Oregon |
| United States | Mylan Investigative Site #79 | Providence | Rhode Island |
| United States | Mylan Investigative Site #93 | Provo | Utah |
| United States | Mylan Investigative Site #64 | Raleigh | North Carolina |
| United States | Mylan Investigative Site #39 | River Forest | Illinois |
| United States | Mylan Investigative Site #18 | Riverside | California |
| United States | Mylan Investigative Site #52 | Rolla | Missouri |
| United States | Mylan Investigational Site #27 | Rolling Hills Estates | California |
| United States | Mylan Investigative Site #19 | Sacramento | California |
| United States | Mylan Investigative Site #53 | Saint Louis | Missouri |
| United States | Mylan Investigative Site #90 | San Antonio | Texas |
| United States | Mylan Investigative Site #91 | San Antonio | Texas |
| United States | Mylan Investigative Site #20 | San Diego | California |
| United States | Mylan Investigative Site #21 | San Jose | California |
| United States | Mylan Investigative Site #96 | Seattle | Washington |
| United States | Mylan Investigative Site #40 | Shiloh | Illinois |
| United States | Mylan Investigative Site #60 | Skillman | New Jersey |
| United States | Mylan Investigative Site #78 | Smithfield | Pennsylvania |
| United States | Mylan Investigative Site #94 | South Burlington | Vermont |
| United States | Mylan Investigative Site #82 | Spartanburg | South Carolina |
| United States | Mylan Investigative Site #83 | Spartanburg | South Carolina |
| United States | Mylan Investigative Site #97 | Spokane | Washington |
| United States | Mylan Investigative Site #68 | Sylvania | Ohio |
| United States | Mylan Investigative Site #98 | Tacoma | Washington |
| United States | Mylan Investigative Site #99 | Tacoma | Washington |
| United States | Mylan Investigative Site #37 | Tallahassee | Florida |
| United States | Mylan Investigative Site #69 | Toledo | Ohio |
| United States | Mylan Investigative Site #71 | Tulsa | Oklahoma |
| United States | Mylan Investigative Site #92 | Waco | Texas |
| United States | Mylan Investigative Site #54 | Warrensburg | Missouri |
| United States | Mylan Investigative Site #80 | Warwick | Rhode Island |
| United States | Mylan Investigative Site #26 | Wheat Ridge | Colorado |
| United States | Mylan Investigative Site #45 | Wheaton | Maryland |
| United States | Mylan Investigative Site #46 | White Marsh | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| Mylan Pharma UK Ltd. |
United States,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 |
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