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MGR001 / Advair Diskus Local Equivalence Study in Asthma

Information source: Mylan Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) (Drug); Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate) (Drug); Placebo (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Mylan Inc.

Official(s) and/or principal investigator(s):
Dik WH Ng, Study Director, Affiliation: Mylan Pharma UK Ltd.

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Forced Exhaled Volume in 1 sec (FEV1) area under the effect curve

FEV1 trough value

Secondary outcome: Adverse events

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Mylan Investigative Site #1, Birmingham, Alabama 35209, United States

Mylan Investigative Site #2, Little Rock, Arkansas 72205, United States

Mylan Investigative Site #3, Anaheim, California 92801, United States

Mylan Investigative Site #4, Bakersfield, California 93301, United States

Mylan Investigative Site #5, Burbank, California 91505, United States

Mylan Investigative Site #6, Costa Mesa, California 92626, United States

Mylan Investigative Site #7, Encinitas, California 92024, United States

Mylan Investigative Site #8, Fresno, California 93720, United States

Mylan Investigative Site #9, Fullerton, California 92835, United States

Mylan Investigative Site #10, Huntington Beach, California 92647, United States

Mylan Investigative Site #11, Huntington Beach, California 92647, United States

Mylan Investigative Site #12, Los Angeles, California 90025, United States

Mylan Investigative Site #13, Los Angeles, California 90025, United States

Mylan Investigative Site #14, Los Angeles, California 90048, United States

Mylan Investigative Site #15, Mission Viejo, California 92691, United States

Mylan Investigative Site #16, Napa, California 94558, United States

Mylan Investigative Site #17, Orange, California 92868, United States

Mylan Investigative Site #18, Riverside, California 92506, United States

Mylan Investigational Site #27, Rolling Hills Estates, California 90274, United States

Mylan Investigative Site #19, Sacramento, California 95842, United States

Mylan Investigative Site #20, San Diego, California 92123, United States

Mylan Investigative Site #21, San Jose, California 95117, United States

Mylan Investigative Site #101, Centennial, Colorado 80112, United States

Mylan Investigative Site #22, Centennial, Colorado 80112, United States

Mylan Investigative Site #23, Colorado Springs, Colorado 80907, United States

Mylan Investigative Site #24, Colorado Springs, Colorado 80907, United States

Mylan Investigative Site #25, Denver, Colorado 80230, United States

Mylan Investigative Site #26, Wheat Ridge, Colorado 80033, United States

Mylan Investigative Site #28, Coral Gables, Florida 33134, United States

Mylan Investigative Site #29, Gainesville, Florida 32607, United States

Mylan Investigative Site #30, Hialeah, Florida 33012, United States

Mylan Investigative Site #31, Largo, Florida 33770, United States

Mylan Investigative Site #32, Miami, Florida 33015, United States

Mylan Investigative Site #33, Miami, Florida 33134, United States

Mylan Investigative Site #34, Miami, Florida 33133, United States

Mylan Investigative Site #35, Miami, Florida 33155, United States

Mylan Investigative Site #36, New Port Richey, Florida 34653, United States

Mylan Investigative Site #37, Tallahassee, Florida 32308, United States

Mylan Investigative Site #38, Lawrenceville, Georgia 30046, United States

Mylan Investigative Site #39, River Forest, Illinois 60305, United States

Mylan Investigative Site #40, Shiloh, Illinois 62269, United States

Mylan Investigative Site #41, Lenexa, Kansas 66219, United States

Mylan Investigative Site #42, Bangor, Maine 04401, United States

Mylan Investigative Site #43, Baltimore, Maryland 21236, United States

Mylan Investigative Site #44, Bethesda, Maryland 20814, United States

Mylan Investigative Site #45, Wheaton, Maryland 20902, United States

Mylan Investigative Site #46, White Marsh, Maryland 21162, United States

Mylan Investigative Site #47, Fall River, Massachusetts 02720, United States

Mylan Investigative Site #48, North Dartmouth, Massachusetts 02747, United States

Mylan Investigative Site #49, North Dartmouth, Massachusetts 02747, United States

Mylan Investigative Site #50, Minneapolis, Minnesota 55402, United States

Mylan Investigative Site #51, Columbia, Missouri 65203, United States

Mylan Investigative Site #52, Rolla, Missouri 65401, United States

Mylan Investigative Site #53, Saint Louis, Missouri 63141, United States

Mylan Investigative Site #54, Warrensburg, Missouri 64093, United States

Mylan Investigative Site #55, Bozeman, Montana 59718, United States

Mylan Investigative Site #56, Missoula, Montana 59808, United States

Mylan Investigative Site #57, Bellevue, Nebraska 68123-4303, United States

Mylan Investigative Site #58, Brick, New Jersey 08724, United States

Mylan Investigative Site #59, Ocean, New Jersey 07712, United States

Mylan Investigative Site #60, Skillman, New Jersey 08558, United States

Mylan Investigative Site #61, New York, New York 11570, United States

Mylan Investigative Site #62, Asheville, North Carolina 28801, United States

Mylan Investigative Site #63, Charlotte, North Carolina 28207, United States

Mylan Investigative Site #64, Raleigh, North Carolina 27607, United States

Mylan Investigative Site #65, Canton, Ohio 44718, United States

Mylan Investigative Site #66, Cincinnati, Ohio 45231, United States

Mylan Investigative Site #67, Cincinnati, Ohio 45242, United States

Mylan Investigative Site #68, Sylvania, Ohio 43560, United States

Mylan Investigative Site #69, Toledo, Ohio 43617, United States

Mylan Investigative Site #70, Oklahoma City, Oklahoma 73112, United States

Mylan Investigative Site #71, Tulsa, Oklahoma 74136-8303, United States

Mylan Investigative Site #72, Eugene, Oregon 97401, United States

Mylan Investigative Site #73, Lake Oswego, Oregon 97035, United States

Mylan Investigative Site #74, Medford, Oregon 97504, United States

Mylan Investigative Site #75, Portland, Oregon 97202, United States

Mylan Investigative Site #76, Jenkintown, Pennsylvania 19046, United States

Mylan Investigative Site #77, Pittsburgh, Pennsylvania 15243, United States

Mylan Investigative Site #78, Smithfield, Pennsylvania 15478, United States

Mylan Investigative Site #79, Providence, Rhode Island 02906, United States

Mylan Investigative Site #80, Warwick, Rhode Island 02886, United States

Mylan Investigative Site #81, North Charleston, South Carolina 29420, United States

Mylan Investigative Site #82, Spartanburg, South Carolina 29303, United States

Mylan Investigative Site #83, Spartanburg, South Carolina 29303, United States

Mylan Investigative Site #84, Boerne, Texas 78006, United States

Mylan Investigative Site #85, Dallas, Texas 75231, United States

Mylan Investigative Site #86, Dallas, Texas 75231, United States

Mylan Investigative Site #87, Dickinson, Texas 77539, United States

Mylan Investigative Site #88, El Paso, Texas 79903, United States

Mylan Investigative Site #89, New Braunfels, Texas 78130, United States

Mylan Investigative Site #90, San Antonio, Texas 78229, United States

Mylan Investigative Site #91, San Antonio, Texas 78229, United States

Mylan Investigative Site #92, Waco, Texas 76712, United States

Mylan Investigative Site #93, Provo, Utah 84604, United States

Mylan Investigative Site #94, South Burlington, Vermont 05403, United States

Mylan Investigative Site #95, Henrico, Virginia 23233, United States

Mylan Investigative Site #96, Seattle, Washington 98115, United States

Mylan Investigative Site #97, Spokane, Washington 99204, United States

Mylan Investigative Site #98, Tacoma, Washington 98405, United States

Mylan Investigative Site #99, Tacoma, Washington 98405, United States

Mylan Investigative Site #100, Greenfield, Wisconsin 53228, United States

Additional Information

Starting date: October 2014
Last updated: June 10, 2015

Page last updated: August 23, 2015

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