Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

RECRUITING

NCT06283966

PHASE3

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

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

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)

Key Details

Gender

All

Age Range

40 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

5250

Start Date

2024-02-21

Completion Date

2027-12-03

Last Updated

2026-10-02

Healthy Volunteers

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Interventions

DRUG

BGF MDI 320/14.4/9.6 μg

Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension

DRUG

GFF MDI 14.4/9.6 μg

Glycopyrronium and formoterol fumarate pressurized inhalation suspension

Inclusion Criteria: 1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF. 2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2) 3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70% at V1. 4. Current or former smokers with a history of at least 10 pack-years of cigarette smoking; defined as (number of cigarettes per day/20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to V1. 5. A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by the central laboratory 6. A CAT score of ≥ 10 at Visit 1. 7. Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below \[(a), (b), (c), or (d)\]: 1. : Established CV Disease 2. : Combination of CV risk factors: * Hypertension * Diabetes Mellitus * Chronic Kidney Disease * Dyslipidemia * Obesity 3. : High risk of CV disease determined using an established CV risk assessment tool. 4. : CT coronary Artery Calcification 8. Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as required by the protocol. 9. Willing to visit at the study site or participate in virtual visits as required per the protocol to complete all study assessments. 10. A female is eligible to enter and participate in the study if the female is of: * Non-childbearing potential: either permanently sterilized or who are post-menopausal. * Childbearing potential: has a negative serum pregnancy test at V1 and must use one highly effective form of birth control. 11. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol. Exclusion Criteria: 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. End-stage renal disease requiring renal replacement therapy 3. History of heart or lung transplant or actively listed for heart or lung transplant. 4. Implanted left ventricular assist device or implant anticipated in \< 3 months. 5. History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1. 6. Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded: 1. An MI or unstable angina in the last 8 weeks 2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks. NOTE: Any participant who experiences unstable or life-threatening cardiac disease during the run-in period will be excluded but can be rescreened 8 weeks after the resolution of the event. 7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1 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. 9. Use of maintenance ICS treatment within the past 12 months. 10. Unable to abstain from protocol-defined prohibited medications 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). 12. Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI. 13. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 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. 15. Previous randomization in the present study. 16. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding

Locations (922)

Research Site

Athens, Alabama, United States

Research Site

Cullman, Alabama, United States

Research Site

Fairhope, Alabama, United States

Research Site

Huntsville, Alabama, United States

Research Site

Mobile, Alabama, United States

Research Site

Sheffield, Alabama, United States

Research Site

Gilbert, Arizona, United States

Research Site

Glendale, Arizona, United States

Research Site

Mesa, Arizona, United States

Research Site

Mesa, Arizona, United States

Research Site

Phoenix, Arizona, United States

Research Site

Tempe, Arizona, United States

Research Site

Tempe, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

Apple Valley, California, United States

Research Site

Canoga Park, California, United States

Research Site

Castroville, California, United States

Research Site

Garden Grove, California, United States

Research Site

Gardena, California, United States

Research Site

Inglewood, California, United States

Research Site

La Mesa, California, United States

Research Site

La Palma, California, United States

Research Site

Lomita, California, United States

Research Site

Long Beach, California, United States

Research Site

Los Alamitos, California, United States

Research Site

Mission Viejo, California, United States

Research Site

Newport Beach, California, United States

Research Site

North Hollywood, California, United States

Research Site

Pomona, California, United States

Research Site

Sacramento, California, United States

Research Site

Sacramento, California, United States

Research Site

San Bernardino, California, United States

Research Site

San Diego, California, United States

Research Site

San Dimas, California, United States

Research Site

Santa Ana, California, United States

Research Site

Tarzana, California, United States

Research Site

Thousand Oaks, California, United States

Research Site

Van Nuys, California, United States

Research Site

Vista, California, United States

Research Site

Westminster, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Denver, Colorado, United States

Research Site

Englewood, Colorado, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

Boynton Beach, Florida, United States

Research Site

Bradenton, Florida, United States

Research Site

Cape Coral, Florida, United States

Research Site

Clearwater, Florida, United States

Research Site

Clearwater, Florida, United States

Research Site

Crystal River, Florida, United States

Research Site

Cutler Bay, Florida, United States

Research Site

Edgewater, Florida, United States

Research Site

Fort Lauderdale, Florida, United States

Research Site

Fort Myers, Florida, United States

Research Site

Hialeah, Florida, United States

Research Site

Hialeah, Florida, United States

Research Site

Hollywood, Florida, United States

Research Site

Homestead, Florida, United States

Research Site

Kissimmee, Florida, United States

Research Site

Kissimmee, Florida, United States

Research Site

Lake City, Florida, United States

Research Site

Lake City, Florida, United States

Research Site

Lake Worth, Florida, United States

Research Site

Lakeland, Florida, United States

Research Site

Lakeland, Florida, United States

Research Site

Loxahatchee Groves, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Miami, Florida, United States

Research Site

Miami Lakes, Florida, United States

Research Site

Naples, Florida, United States

Research Site

Ocala, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Ormond Beach, Florida, United States

Research Site

Pembroke Pines, Florida, United States

Research Site

Plantation, Florida, United States

Research Site

St. Petersburg, Florida, United States

Research Site

St. Petersburg, Florida, United States

Research Site

Sun City Center, Florida, United States

Research Site

Tamarac, Florida, United States

Research Site

Tamarac, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Tampa, Florida, United States

Research Site

Fayetteville, Georgia, United States

Research Site

Peachtree Corners, Georgia, United States

Research Site

Savannah, Georgia, United States

Research Site

Tucker, Georgia, United States

Research Site

Boise, Idaho, United States

Research Site

Chicago, Illinois, United States

Research Site

Winfield, Illinois, United States

Research Site

Valparaiso, Indiana, United States

Research Site

Sioux City, Iowa, United States

Research Site

Newton, Kansas, United States

Research Site

Wichita, Kansas, United States

Research Site

Lexington, Kentucky, United States

Research Site

Paducah, Kentucky, United States

And 822 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (922)