Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistant Asthma
A Randomized, Double-Blind, Parallel Group, Multi-Center 24-Week Study Comparing the Efficacy and Safety of Three Doses of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma
1 other identifier
interventional
1,077
1 country
232
Brief Summary
Study Comparing the Efficacy and Safety of PT001 to Placebo and Open-label Spiriva® Respimat® in Subjects With Persistent Asthma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Dec 2017
Typical duration for phase_2 asthma
232 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2017
CompletedFirst Posted
Study publicly available on registry
November 30, 2017
CompletedStudy Start
First participant enrolled
December 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 12, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 12, 2019
CompletedResults Posted
Study results publicly available
August 12, 2020
CompletedAugust 12, 2020
August 1, 2020
1.7 years
November 20, 2017
May 22, 2020
August 11, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve From 0 to 4 Hours (AUC0-4)
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4)AUC was normalized for length of follow up (e.g. typically 4 hours).
Week 24
Secondary Outcomes (5)
Change From Baseline in Morning Pre-dose Trough FEV1
Week 24
Rate of Moderate to Severe Asthma Exacerbations
over 24 Weeks (timepoints of 4, 12 & 20 weeks)
Change From Baseline in ACQ-7 (Asthma Control Questionnaire)
Week 24
Change From Baseline in ACQ-5 (Asthma Control Questionnaire)
Week 24
Change From Baseline in Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ +12)
Week 24
Study Arms (5)
GP MDI 28.8 μg
EXPERIMENTALGP MDI 14.4 μg per actuation taken as 2 inhalations BID
GP MDI 14.4 μg
EXPERIMENTALGP MDI 7.2 μg per actuation taken as 2 inhalations BID
GP MDI 7.2 μg
EXPERIMENTALGP MDI 3.6 μg per actuation taken as 2 inhalations BID
Placebo MDI
PLACEBO COMPARATORTaken as 2 inhalations BID
Spiriva Respimat 2.5 μg
OTHEROpen Label Spiriva Respimat 2.5 μg
Interventions
GP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID
GP MDI (PT001) 7.2 μg per actuation taken as 2 inhalations BID
GP MDI (PT001) 3.6 μg per actuation taken as 2 inhalations BID
Spiriva Respimat 2.5 μg QD (open-label)
Eligibility Criteria
You may qualify if:
- Have a documented history of physician-diagnosed asthma
- 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
You may not qualify if:
- Oral corticosteroid use (any dose) within 4 weeks
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (232)
Research Site
Birmingham, Alabama, 35209, United States
Research Site
Birmingham, Alabama, 35243, United States
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Dothan, Alabama, 36303, United States
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Guntersville, Alabama, 35976, United States
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Jasper, Alabama, 35501, United States
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Scottsboro, Alabama, 35768, United States
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Chandler, Arizona, 85224, United States
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Flagstaff, Arizona, 86001, United States
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Phoenix, Arizona, 85018, United States
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Tempe, Arizona, 85283, United States
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Tucson, Arizona, 85710, United States
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Tucson, Arizona, 85745, United States
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Little Rock, Arkansas, 72205, United States
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Little Rock, Arkansas, 72209, United States
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Little Rock, Arkansas, 72212, United States
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Anaheim, California, 92801, United States
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Bakersfield, California, 93301, United States
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Corona, California, 92879, United States
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Costa Mesa, California, 92627, United States
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El Cajon, California, 92020, United States
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Encinitas, California, 92024, United States
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Fresno, California, 93702, United States
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Fullerton, California, 92835, United States
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Gold River, California, 95670, United States
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Huntington Beach, California, 92647, United States
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Long Beach, California, 90036, United States
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Long Beach, California, 90806, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90048, United States
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Mission Viejo, California, 92691, United States
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Newport Beach, California, 92663, United States
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North Hollywood, California, 91606, United States
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Northridge, California, 91324, United States
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Orange, California, 92868, United States
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Palmdale, California, 93551, United States
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Poway, California, 92064, United States
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Quartz Hill, California, 93536, United States
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Rancho Mirage, California, 92270, United States
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Riverside, California, 92506, United States
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Rolling Hills Estates, California, 90274, United States
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Sacramento, California, 95821, United States
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Sacramento, California, 95823, United States
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Sacramento, California, 95831, United States
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San Diego, California, 92117, United States
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San Diego, California, 92119, United States
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San Diego, California, 92120, United States
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San Diego, California, 92123, United States
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San Jose, California, 95117, United States
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Stockton, California, 95207, United States
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Thousand Oaks, California, 91360, United States
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Tustin, California, 92780, United States
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Westminster, California, 92683, United States
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Centennial, Colorado, 80112, United States
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Colorado Springs, Colorado, 80907, United States
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Colorado Springs, Colorado, 80910, United States
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Lafayette, Colorado, 80026, United States
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Wheat Ridge, Colorado, 80033, United States
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Hamden, Connecticut, 06517, United States
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Aventura, Florida, 33180, United States
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Brandon, Florida, 33511, United States
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Clearwater, Florida, 33756, United States
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Clearwater, Florida, 33765, United States
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Gainesville, Florida, 32653, United States
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Hialeah, Florida, 33012, United States
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Hialeah, Florida, 33013, United States
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Hialeah, Florida, 33016, United States
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Kissimmee, Florida, 34741, United States
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Lake City, Florida, 32055, United States
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Loxahatchee Groves, Florida, 33470, United States
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Miami, Florida, 33126, United States
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Miami, Florida, 33174, United States
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Miami, Florida, 33175, United States
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Miami, Florida, 33176, United States
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Miami, Florida, 33186, United States
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Ocala, Florida, 34471, United States
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Ocoee, Florida, 34761, United States
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Orlando, Florida, 32811, United States
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Panama City, Florida, 32405, United States
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Pembroke Pines, Florida, 33029, United States
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Saint Cloud, Florida, 34769, United States
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Tallahassee, Florida, 32308, United States
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Tampa, Florida, 33603, United States
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Winter Park, Florida, 32789, United States
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Adairsville, Georgia, 30103, United States
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Albany, Georgia, 31707, United States
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Atlanta, Georgia, 30345, United States
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Columbus, Georgia, 31904, United States
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Dacula, Georgia, 30019, United States
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Gainesville, Georgia, 30501, United States
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Lawrenceville, Georgia, 30046, United States
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Norcross, Georgia, 30071, United States
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Rincon, Georgia, 31326, United States
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Savannah, Georgia, 31406, United States
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Stockbridge, Georgia, 30281, United States
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Boise, Idaho, 83706, United States
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Meridian, Idaho, 83646, United States
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Evergreen Park, Illinois, 60805, United States
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O'Fallon, Illinois, 62269, United States
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River Forest, Illinois, 60305, United States
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Brownsburg, Indiana, 46112, United States
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Michigan City, Indiana, 46360, United States
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Fort Mitchell, Kentucky, 41017, United States
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Crowley, Louisiana, 70526, United States
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Shreveport, Louisiana, 71106, United States
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Zachary, Louisiana, 70791, United States
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Bangor, Maine, 04401, United States
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Chevy Chase, Maryland, 20815, United States
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White Marsh, Maryland, 21162, United States
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Fall River, Massachusetts, 02721, United States
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North Dartmouth, Massachusetts, 02747, United States
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Ann Arbor, Michigan, 48106, United States
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Farmington Hills, Michigan, 48336, United States
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Rochester, Michigan, 48307, United States
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Troy, Michigan, 48085, United States
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Edina, Minnesota, 55435, United States
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Fridley, Minnesota, 55432, United States
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Minneapolis, Minnesota, 55402, United States
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Minneapolis, Minnesota, 55407, United States
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Woodbury, Minnesota, 55125, United States
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Chesterfield, Missouri, 63017, United States
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Columbia, Missouri, 65203, United States
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Saint Charles, Missouri, 63301, United States
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St Louis, Missouri, 63141, United States
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Bellevue, Nebraska, 68005, United States
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Bellevue, Nebraska, 68123, United States
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Lincoln, Nebraska, 68505, United States
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Omaha, Nebraska, 68114, United States
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Las Vegas, Nevada, 89106, United States
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Las Vegas, Nevada, 89119, United States
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Las Vegas, Nevada, 89146, United States
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Reno, Nevada, 89503, United States
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Berlin, New Jersey, 08009, United States
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Ocean City, New Jersey, 07712, United States
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Skillman, New Jersey, 08558, United States
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Toms River, New Jersey, 08755, United States
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Albuquerque, New Mexico, 87108, United States
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Albuquerque, New Mexico, 87109, United States
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Cortland, New York, 13045, United States
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New York, New York, 10016, United States
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The Bronx, New York, 10455, United States
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The Bronx, New York, 10468, United States
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Watertown, New York, 13601, United States
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Burlington, North Carolina, 27215, United States
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Charlotte, North Carolina, 28207, United States
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Charlotte, North Carolina, 28277, United States
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Elizabeth City, North Carolina, 27909, United States
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Gastonia, North Carolina, 28054, United States
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Greensboro, North Carolina, 27408, United States
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Hickory, North Carolina, 28078, United States
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Huntersville, North Carolina, 28078, United States
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Monroe, North Carolina, 28112, United States
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Mooresville, North Carolina, 28117, United States
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New Bern, North Carolina, 28562, United States
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Raleigh, North Carolina, 27612, United States
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Winston-Salem, North Carolina, 27103, United States
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Fargo, North Dakota, 58103, United States
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Fargo, North Dakota, 58104, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45231, United States
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Cincinnati, Ohio, 45242, United States
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Columbus, Ohio, 43207, United States
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Dayton, Ohio, 45419, United States
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Dayton, Ohio, 45459, United States
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Dublin, Ohio, 43016, United States
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Marion, Ohio, 43302, United States
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Wooster, Ohio, 44691, United States
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Edmond, Oklahoma, 73034, United States
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Oklahoma City, Oklahoma, 73131, United States
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Tulsa, Oklahoma, 74136, United States
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Clackamas, Oregon, 97015-5737, United States
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Medford, Oregon, 97504, United States
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Portland, Oregon, 97202, United States
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Monroeville, Pennsylvania, 15665, United States
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Pittsburgh, Pennsylvania, 15236, United States
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Pittsburgh, Pennsylvania, 15241, United States
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Wyomissing, Pennsylvania, 19610, United States
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East Providence, Rhode Island, 02914, United States
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Warwick, Rhode Island, 02886, United States
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Anderson, South Carolina, 29621, United States
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Charleston, South Carolina, 29406, United States
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Gaffney, South Carolina, 29340, United States
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Gaffney, South Carolina, 29341, United States
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Greenville, South Carolina, 29615, United States
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Hodges, South Carolina, 29653, United States
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Mt. Pleasant, South Carolina, 29464, United States
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Myrtle Beach, South Carolina, 29588, United States
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Rock Hill, South Carolina, 29732, United States
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Spartanburg, South Carolina, 29301, United States
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Spartanburg, South Carolina, 29303, United States
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Union, South Carolina, 29379, United States
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Rapid City, South Dakota, 57702, United States
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Franklin, Tennessee, 37067, United States
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Hendersonville, Tennessee, 37075, United States
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Johnson City, Tennessee, 37601, United States
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Smyrna, Tennessee, 37167, United States
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Amarillo, Texas, 79106, United States
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Austin, Texas, 78759, United States
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Boerne, Texas, 78006, United States
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Carrollton, Texas, 75007, United States
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Dallas, Texas, 75231, United States
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Dallas, Texas, 75235, United States
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El Paso, Texas, 79903, United States
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Houston, Texas, 77058, United States
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Houston, Texas, 77074, United States
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Houston, Texas, 77099, United States
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Kerrville, Texas, 78028, United States
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Killeen, Texas, 76542, United States
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Lampasas, Texas, 76550, United States
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Live Oak, Texas, 78233, United States
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Lufkin, Texas, 75904, United States
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Pearland, Texas, 77584, United States
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Plano, Texas, 75093, United States
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San Antonio, Texas, 78205, United States
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San Antonio, Texas, 78215, United States
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San Antonio, Texas, 78229, United States
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San Antonio, Texas, 78258, United States
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Sherman, Texas, 75092, United States
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Tomball, Texas, 77375, United States
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Waco, Texas, 76712, United States
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Murray, Utah, 84107, United States
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Salt Lake City, Utah, 84102, United States
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Salt Lake City, Utah, 84107, United States
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South Burlington, Vermont, 05403, United States
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Abingdon, Virginia, 24210, United States
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Newport News, Virginia, 23606, United States
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Richmond, Virginia, 23114, United States
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Richmond, Virginia, 23226, United States
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Bellingham, Washington, 98225, United States
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Spokane Valley, Washington, 99216, United States
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Tacoma, Washington, 98405, United States
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Morgantown, West Virginia, 26505, United States
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Greenfield, Wisconsin, 53228, United States
Related Publications (1)
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.
PMID: 36472162DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pearl Therapeutics, Inc.
- Organization
- Pearl Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double Blind vs Placebo, Open Label Spiriva Respimat
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2017
First Posted
November 30, 2017
Study Start
December 13, 2017
Primary Completion
September 12, 2019
Study Completion
September 12, 2019
Last Updated
August 12, 2020
Results First Posted
August 12, 2020
Record last verified: 2020-08