Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma
NCT ID: NCT03358147
Last Updated: 2020-08-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
1077 participants
INTERVENTIONAL
2017-12-13
2019-09-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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GP MDI 28.8 μg
GP MDI 14.4 μg per actuation taken as 2 inhalations BID
GP MDI 28.8 μg
GP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID
GP MDI 14.4 μg
GP MDI 7.2 μg per actuation taken as 2 inhalations BID
GP MDI 14.4 μg
GP MDI (PT001) 7.2 μg per actuation taken as 2 inhalations BID
GP MDI 7.2 μg
GP MDI 3.6 μg per actuation taken as 2 inhalations BID
GP MDI 7.2 μg
GP MDI (PT001) 3.6 μg per actuation taken as 2 inhalations BID
Placebo MDI
Taken as 2 inhalations BID
Placebo MDI
Placebo taken as 2 inhalations BID
Spiriva Respimat 2.5 μg
Open Label Spiriva Respimat 2.5 μg
Spiriva Respimat 2.5 μg
Spiriva Respimat 2.5 μg QD (open-label)
Interventions
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GP MDI 28.8 μg
GP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID
GP MDI 14.4 μg
GP MDI (PT001) 7.2 μg per actuation taken as 2 inhalations BID
GP MDI 7.2 μg
GP MDI (PT001) 3.6 μg per actuation taken as 2 inhalations BID
Placebo MDI
Placebo taken as 2 inhalations BID
Spiriva Respimat 2.5 μg
Spiriva Respimat 2.5 μg QD (open-label)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Require inhaled asthma maintenance therapy: has been regularly using an ICS/LABA on a stable regimen for at least 4 weeks
* Documented reversibility to albuterol
* A pre-bronchodilator FEV1 \>40% and \<85% of predicted normal value for subjects 18 to 80 years of age or \>40% and \<90% of predicted for subjects 12 to \<18 years of age
* Demonstrate acceptable spirometry performance
* Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol
* Compliance: must be willing to remain at the study center as required per protocol to complete all visit assessments
Exclusion Criteria
* Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months (including all forms of tobacco, e-cigarettes, and marijuana)
* Life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
* Completed treatment for lower respiratory infection or asthma exacerbation within 4 weeks
* Hospitalizations for asthma within 3 months
* Historical or current evidence of a clinically significant disease
* Cancer not in complete remission for at least 5 years
* Treatment with investigational study drug (or device) in another clinical study within the last 30 days or 5 half-lives, whichever is longer
* Previously randomized in any PT001 study
12 Years
80 Years
ALL
No
Sponsors
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Pearl Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Guntersville, Alabama, United States
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Jasper, Alabama, United States
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Scottsboro, Alabama, United States
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Chandler, Arizona, United States
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Flagstaff, Arizona, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Bakersfield, California, United States
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Corona, California, United States
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Costa Mesa, California, United States
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El Cajon, California, United States
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Encinitas, California, United States
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Fresno, California, United States
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Fullerton, California, United States
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Gold River, California, United States
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Huntington Beach, California, United States
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Long Beach, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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Newport Beach, California, United States
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North Hollywood, California, United States
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Northridge, California, United States
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Orange, California, United States
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Palmdale, California, United States
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Poway, California, United States
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Quartz Hill, California, United States
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Rancho Mirage, California, United States
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Riverside, California, United States
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Rolling Hills Estates, California, United States
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Sacramento, California, United States
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Sacramento, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Stockton, California, United States
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Thousand Oaks, California, United States
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Tustin, California, United States
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Westminster, California, United States
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Centennial, Colorado, United States
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Colorado Springs, Colorado, United States
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Colorado Springs, Colorado, United States
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Lafayette, Colorado, United States
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Wheat Ridge, Colorado, United States
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Hamden, Connecticut, United States
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Aventura, Florida, United States
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Brandon, Florida, United States
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Clearwater, Florida, United States
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Clearwater, Florida, United States
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Gainesville, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Kissimmee, Florida, United States
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Lake City, Florida, United States
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Loxahatchee Groves, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Ocala, Florida, United States
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Ocoee, Florida, United States
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Orlando, Florida, United States
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Panama City, Florida, United States
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Pembroke Pines, Florida, United States
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Saint Cloud, Florida, United States
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Tallahassee, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Adairsville, Georgia, United States
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Albany, Georgia, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Dacula, Georgia, United States
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Gainesville, Georgia, United States
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Lawrenceville, Georgia, United States
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Norcross, Georgia, United States
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Rincon, Georgia, United States
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Savannah, Georgia, United States
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Stockbridge, Georgia, United States
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Boise, Idaho, United States
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Meridian, Idaho, United States
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Evergreen Park, Illinois, United States
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O'Fallon, Illinois, United States
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River Forest, Illinois, United States
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Brownsburg, Indiana, United States
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Michigan City, Indiana, United States
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Fort Mitchell, Kentucky, United States
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Crowley, Louisiana, United States
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Shreveport, Louisiana, United States
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Zachary, Louisiana, United States
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Bangor, Maine, United States
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Chevy Chase, Maryland, United States
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White Marsh, Maryland, United States
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Fall River, Massachusetts, United States
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North Dartmouth, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Farmington Hills, Michigan, United States
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Rochester, Michigan, United States
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Troy, Michigan, United States
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Edina, Minnesota, United States
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Fridley, Minnesota, United States
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Minneapolis, Minnesota, United States
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Minneapolis, Minnesota, United States
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Woodbury, Minnesota, United States
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Chesterfield, Missouri, United States
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Columbia, Missouri, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Bellevue, Nebraska, United States
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Bellevue, Nebraska, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Las Vegas, Nevada, United States
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Reno, Nevada, United States
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Berlin, New Jersey, United States
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Ocean City, New Jersey, United States
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Skillman, New Jersey, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albuquerque, New Mexico, United States
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Cortland, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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The Bronx, New York, United States
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Watertown, New York, United States
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Burlington, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Elizabeth City, North Carolina, United States
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Gastonia, North Carolina, United States
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Greensboro, North Carolina, United States
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Hickory, North Carolina, United States
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Huntersville, North Carolina, United States
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Monroe, North Carolina, United States
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Mooresville, North Carolina, United States
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New Bern, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Fargo, North Dakota, United States
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Cincinnati, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Dayton, Ohio, United States
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Dublin, Ohio, United States
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Marion, Ohio, United States
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Wooster, Ohio, United States
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Edmond, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Clackamas, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Monroeville, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Warwick, Rhode Island, United States
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Anderson, South Carolina, United States
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Charleston, South Carolina, United States
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Gaffney, South Carolina, United States
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Gaffney, South Carolina, United States
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Greenville, South Carolina, United States
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Hodges, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Myrtle Beach, South Carolina, United States
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Rock Hill, South Carolina, United States
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Spartanburg, South Carolina, United States
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Spartanburg, South Carolina, United States
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Union, South Carolina, United States
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Rapid City, South Dakota, United States
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Franklin, Tennessee, United States
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Hendersonville, Tennessee, United States
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Johnson City, Tennessee, United States
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Smyrna, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Boerne, Texas, United States
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Carrollton, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Kerrville, Texas, United States
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Killeen, Texas, United States
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Lampasas, Texas, United States
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Live Oak, Texas, United States
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Lufkin, Texas, United States
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Pearland, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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San Antonio, Texas, United States
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Sherman, Texas, United States
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Tomball, Texas, United States
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Waco, Texas, United States
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Murray, Utah, United States
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Salt Lake City, Utah, United States
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Salt Lake City, Utah, United States
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South Burlington, Vermont, United States
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Abingdon, Virginia, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Bellingham, Washington, United States
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Spokane Valley, Washington, United States
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Tacoma, Washington, United States
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Morgantown, West Virginia, United States
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Greenfield, Wisconsin, United States
Countries
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References
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Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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PT001102
Identifier Type: -
Identifier Source: org_study_id
NCT03547466
Identifier Type: -
Identifier Source: nct_alias
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