RECRUITING

A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

Official Title

A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)

Quick Facts

Study Start:2024-02-21
Study Completion:2028-03-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06283966

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing
  2. 2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)
  3. 3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70%
  4. 4. Current or former smokers with a history of at least 10 pack-years of cigarette smoking;
  5. 5. A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by
  6. 6. A CAT score of ≥ 10 at Visit 1.
  7. 7. Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below \[(a), (b),
  8. 1. : Established CV Disease
  9. 2. : Combination of CV risk factors:
  10. * Hypertension
  11. * Diabetes Mellitus
  12. * Chronic Kidney Disease
  13. * Dyslipidemia
  14. * Obesity
  15. 3. : High risk of CV disease determined using an established CV risk assessment
  16. 4. : CT coronary Artery Calcification
  17. 8. Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as
  18. 9. Willing to visit at the study site or participate in virtual visits as required per the protocol
  19. 10. A female is eligible to enter and participate in the study if the female is of:
  20. * Non-childbearing potential: either permanently sterilized or who are post-menopausal.
  21. * Childbearing potential: has a negative serum pregnancy test at V1 and must use one
  22. 11. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.
  1. 1. Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
  2. 2. End-stage renal disease requiring renal replacement therapy
  3. 3. History of heart or lung transplant or actively listed for heart or lung transplant.
  4. 4. Implanted left ventricular assist device or implant anticipated in \< 3 months.
  5. 5. History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1.
  6. 6. Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded:
  7. 1. An MI or unstable angina in the last 8 weeks
  8. 2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks.
  9. 7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1
  10. 8. Any life-threatening condition, including malignancy, with a life expectancy \< 5 years, other than CV disease or COPD, that might prevent the participant from completing the study.
  11. 9. Use of maintenance ICS treatment within the past 12 months.
  12. 10. Unable to abstain from protocol-defined prohibited medications
  13. 11. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in protocol is prohibited for use during the duration of the study).
  14. 12. Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI.
  15. 13. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  16. 14. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
  17. 15. Previous randomization in the present study.
  18. 16. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479
information.center@astrazeneca.com

Study Locations (Sites)

Research Site
Athens, Alabama, 35611
United States
Research Site
Cullman, Alabama, 35058
United States
Research Site
Fairhope, Alabama, 36532
United States
Research Site
Huntsville, Alabama, 35801
United States
Research Site
Mobile, Alabama, 36608
United States
Research Site
Sheffield, Alabama, 35660
United States
Research Site
Gilbert, Arizona, 85296
United States
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Glendale, Arizona, 85308
United States
Research Site
Mesa, Arizona, 85206
United States
Research Site
Mesa, Arizona, 85213
United States
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Phoenix, Arizona, 85006
United States
Research Site
Tempe, Arizona, 85281
United States
Research Site
Tempe, Arizona, 85283
United States
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Tucson, Arizona, 85710
United States
Research Site
Tucson, Arizona, 85715
United States
Research Site
Apple Valley, California, 92307
United States
Research Site
Banning, California, 92220
United States
Research Site
Canoga Park, California, 91303
United States
Research Site
Castroville, California, 95012
United States
Research Site
Garden Grove, California, 92844
United States
Research Site
Gardena, California, 90247
United States
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Inglewood, California, 90301
United States
Research Site
La Mesa, California, 91942
United States
Research Site
La Palma, California, 90623
United States
Research Site
Lomita, California, 90717
United States
Research Site
Los Alamitos, California, 90720
United States
Research Site
Newport Beach, California, 92660
United States
Research Site
Newport Beach, California, 92663
United States
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North Hollywood, California, 91602
United States
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Panorama City, California, 91402
United States
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Pomona, California, 91768
United States
Research Site
Sacramento, California, 95823
United States
Research Site
Sacramento, California, 95831
United States
Research Site
San Diego, California, 92111
United States
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San Dimas, California, 91773
United States
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Santa Ana, California, 92704
United States
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Tarzana, California, 91356
United States
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Thousand Oaks, California, 91360
United States
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Vista, California, 92081
United States
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Westminster, California, 92683
United States
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Aurora, Colorado, 80012
United States
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Denver, Colorado, 80224
United States
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Denver, Colorado, 80228
United States
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Washington, District of Columbia, 20016
United States
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Boynton Beach, Florida, 33435
United States
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Bradenton, Florida, 34208
United States
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Cape Coral, Florida, 33990
United States
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Clearwater, Florida, 33756
United States
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Clearwater, Florida, 33765
United States
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Crystal River, Florida, 34429
United States
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Cutler Bay, Florida, 33189
United States
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Edgewater, Florida, 32132
United States
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Fort Lauderdale, Florida, 33308
United States
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Fort Myers, Florida, 33912
United States
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Hialeah, Florida, 33012
United States
Research Site
Hialeah, Florida, 33013
United States
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Hollywood, Florida, 33024
United States
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Kissimmee, Florida, 34741
United States
Research Site
Kissimmee, Florida, 34746
United States
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Lake City, Florida, 32055
United States
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Lake Worth, Florida, 33467
United States
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Lakeland, Florida, 33813
United States
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Loxahatchee Groves, Florida, 33470
United States
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Miami Lakes, Florida, 33014
United States
Research Site
Miami, Florida, 33155
United States
Research Site
Miami, Florida, 33175
United States
Research Site
Miami, Florida, 33175
United States
Research Site
Miami, Florida, 33256
United States
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Naples, Florida, 34102
United States
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Ocala, Florida, 34470
United States
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Orlando, Florida, 32807
United States
Research Site
Orlando, Florida, 32819
United States
Research Site
Orlando, Florida, 32825
United States
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Ormond Beach, Florida, 32174
United States
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Pembroke Pines, Florida, 33024
United States
Research Site
Plantation, Florida, 33324
United States
Research Site
Saint Petersburg, Florida, 33713
United States
Research Site
Sun City Center, Florida, 33573
United States
Research Site
Tamarac, Florida, 33321
United States
Research Site
Tampa, Florida, 33606
United States
Research Site
Tampa, Florida, 33607
United States
Research Site
Tampa, Florida, 33625
United States
Research Site
Atlanta, Georgia, 30349
United States
Research Site
Buford, Georgia, 30519
United States
Research Site
Peachtree Corners, Georgia, 30092
United States
Research Site
Savannah, Georgia, 31406
United States
Research Site
Tucker, Georgia, 30084
United States
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Boise, Idaho, 83706
United States
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Chicago, Illinois, 60607
United States
Research Site
Winfield, Illinois, 60190
United States
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Valparaiso, Indiana, 46383
United States
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Newton, Kansas, 67114
United States
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Wichita, Kansas, 67218
United States
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Lexington, Kentucky, 40503
United States
Research Site
Paducah, Kentucky, 42001
United States
Research Site
Lafayette, Louisiana, 70508
United States
Research Site
Monroe, Louisiana, 71201
United States
Research Site
Shreveport, Louisiana, 71105
United States
Research Site
Zachary, Louisiana, 70791
United States
Research Site
Glen Burnie, Maryland, 21061
United States
Research Site
Oxon Hill, Maryland, 20745
United States
Research Site
Potomac, Maryland, 20854
United States
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Boston, Massachusetts, 02115
United States
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Ann Arbor, Michigan, 48109
United States
Research Site
Flint, Michigan, 48504
United States
Research Site
Lathrup Village, Michigan, 48076
United States
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Southfield, Michigan, 48034
United States
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Gulfport, Mississippi, 39503
United States
Research Site
Olive Branch, Mississippi, 38654
United States
Research Site
Kansas City, Missouri, 64116
United States
Research Site
Liberty, Missouri, 64068
United States
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Saint Louis, Missouri, 63110
United States
Research Site
Saint Louis, Missouri, 63136
United States
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Missoula, Montana, 59808
United States
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Fremont, Nebraska, 68025
United States
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Grand Island, Nebraska, 68803
United States
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Lincoln, Nebraska, 68510
United States
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Omaha, Nebraska, 68134
United States
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Las Vegas, Nevada, 89101
United States
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Las Vegas, Nevada, 89102
United States
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Las Vegas, Nevada, 89119
United States
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Las Vegas, Nevada, 89119
United States
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Las Vegas, Nevada, 89121
United States
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Lawrence Township, New Jersey, 08648
United States
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Mullica Hill, New Jersey, 08062
United States
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Toms River, New Jersey, 08755
United States
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Union City, New Jersey, 07087
United States
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Albuquerque, New Mexico, 87109
United States
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Albany, New York, 12205
United States
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Bronxville, New York, 10708
United States
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Bronx, New York, 10455
United States
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Massapequa, New York, 11758
United States
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New Windsor, New York, 12553
United States
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New York, New York, 10036
United States
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Vestal, New York, 13850
United States
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Fayetteville, North Carolina, 28303
United States
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Greensboro, North Carolina, 27405
United States
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Greenville, North Carolina, 27834
United States
Research Site
Huntersville, North Carolina, 28078
United States
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Morehead City, North Carolina, 28557
United States
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Raleigh, North Carolina, 27612
United States
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Salisbury, North Carolina, 28144
United States
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Statesville, North Carolina, 28625
United States
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Statesville, North Carolina, 28677
United States
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Wilmington, North Carolina, 28401
United States
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Beavercreek, Ohio, 45431
United States
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Blue Ash, Ohio, 45242
United States
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Cleveland, Ohio, 44130
United States
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Columbus, Ohio, 43215
United States
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Columbus, Ohio, 43235
United States
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Marion, Ohio, 43302
United States
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Toledo, Ohio, 43617
United States
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Norman, Oklahoma, 73071
United States
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Oklahoma City, Oklahoma, 73134
United States
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Tulsa, Oklahoma, 74133
United States
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Grants Pass, Oregon, 97527
United States
Research Site
Medford, Oregon, 97504
United States
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Roseburg, Oregon, 97471
United States
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Camp Hill, Pennsylvania, 17011
United States
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DuBois, Pennsylvania, 15801
United States
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Exton, Pennsylvania, 19341
United States
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Philadelphia, Pennsylvania, 19140
United States
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Anderson, South Carolina, 29621
United States
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Charleston, South Carolina, 29414
United States
Research Site
Columbia, South Carolina, 29201
United States
Research Site
Gaffney, South Carolina, 29340
United States
Research Site
Spartanburg, South Carolina, 29303
United States
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Union, South Carolina, 29379
United States
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North Sioux City, South Dakota, 57049
United States
Research Site
Rapid City, South Dakota, 57701
United States
Research Site
Chattanooga, Tennessee, 37421
United States
Research Site
Elizabethton, Tennessee, 37643
United States
Research Site
Franklin, Tennessee, 37067
United States
Research Site
Morristown, Tennessee, 37813
United States
Research Site
Tullahoma, Tennessee, 37388
United States
Research Site
Abilene, Texas, 79606
United States
Research Site
Amarillo, Texas, 79106
United States
Research Site
Austin, Texas, 78704
United States
Research Site
Brownsville, Texas, 78520
United States
Research Site
Dallas, Texas, 75225
United States
Research Site
Dallas, Texas, 75235
United States
Research Site
Denison, Texas, 75020
United States
Research Site
El Paso, Texas, 79902
United States
Research Site
El Paso, Texas, 79902
United States
Research Site
Forney, Texas, 75126
United States
Research Site
Georgetown, Texas, 78633
United States
Research Site
Houston, Texas, 77002
United States
Research Site
Houston, Texas, 77024
United States
Research Site
Houston, Texas, 77025
United States
Research Site
Houston, Texas, 77029
United States
Research Site
Houston, Texas, 77074
United States
Research Site
Houston, Texas, 77079
United States
Research Site
Houston, Texas, 77084
United States
Research Site
Houston, Texas, 77089
United States
Research Site
Houston, Texas, 77207
United States
Research Site
Katy, Texas, 77450
United States
Research Site
Katy, Texas, 77493
United States
Research Site
Kerrville, Texas, 78028
United States
Research Site
Kingwood, Texas, 77339
United States
Research Site
Lewisville, Texas, 75057
United States
Research Site
McAllen, Texas, 78504
United States
Research Site
McKinney, Texas, 75069
United States
Research Site
Paris, Texas, 75462
United States
Research Site
Plano, Texas, 75024
United States
Research Site
Waco, Texas, 76708
United States
Research Site
Wichita Falls, Texas, 76308
United States
Research Site
Wylie, Texas, 75098
United States
Research Site
Bountiful, Utah, 84010
United States
Research Site
Ogden, Utah, 84405
United States
Research Site
Salt Lake City, Utah, 84107
United States
Research Site
West Jordan, Utah, 84088
United States
Research Site
West Valley City, Utah, 84120
United States
Research Site
Newport News, Virginia, 23606
United States
Research Site
Norfolk, Virginia, 23504
United States
Research Site
Portsmouth, Virginia, 23703
United States
Research Site
Richmond, Virginia, 23219
United States
Research Site
Richmond, Virginia, 23226
United States
Research Site
Spokane, Washington, 99218
United States
Research Site
Morgantown, West Virginia, 26505
United States
Research Site
Cudahy, Wisconsin, 53110
United States
Research Site
Milwaukee, Wisconsin, 53228
United States
Research Site
Milwaukee, Wisconsin, 53295
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-21
Study Completion Date2028-03-03

Study Record Updates

Study Start Date2024-02-21
Study Completion Date2028-03-03

Terms related to this study

Additional Relevant MeSH Terms

  • COPD (Chronic Obstructive Pulmonary Disease)