RecruitingPhase 3

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares a three-drug inhaler with a two-drug inhaler to see how they affect heart and lung health. It is for adults with COPD, a long-term lung disease that makes breathing hard, who have a higher risk of heart and lung problems.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 40 to 80 years old and able to sign a form agreeing to join the study.
  • Have COPD confirmed by a breathing test after taking medicine to open the airways. The test ratio, called FEV1/FVC, must be below 70%.
  • Smoke now or have quit at least 6 months ago. Have smoked at least 10 pack-years—for example, 1 pack a day for 10 years.
  • Have a blood eosinophil count of at least 100 cells/mm³. Eosinophils are a type of white blood cell.
  • Score at least 10 on the CAT, a survey about COPD symptoms.
  • Have heart or blood vessel disease; a combination of risk factors such as high blood pressure, diabetes, kidney disease, unhealthy blood fats, or obesity; a high risk score; or calcium buildup in heart arteries seen on a CT scan.
  • Show correct inhaler use at the first two visits. Be willing and able to change COPD medicines as required and complete study visits and tests.
  • Women who can become pregnant must have a negative blood pregnancy test at the first visit and use highly effective birth control. Other women must be past menopause or permanently unable to become pregnant through surgery.

Who can't join

  • Have had active asthma in the past 5 years, have both asthma and COPD, or have another long-term lung disease besides COPD. Asthma only in childhood or the teen years is allowed.
  • Have kidney failure needing dialysis or other kidney replacement treatment; have had or be listed for a heart or lung transplant; or have a heart pump device or expect one within 3 months.
  • Have a history of lung cancer or lung cancer treatment within the past 5 years. Also excluded are other life-threatening illnesses, apart from COPD or heart and blood vessel disease, that may prevent study completion and shorten expected life to under 5 years.
  • Have had a heart attack, unstable chest pain, or a dangerous or unstable heart rhythm needing treatment in the past 8 weeks. Pneumonia or a moderate or severe COPD flare-up must have cleared at least 8 weeks before the first visit.
  • Have used regular inhaled steroid treatment in the past 12 months, cannot stop medicines banned by the study, or are allergic to any study inhaler ingredient.
  • Have received treatment in another study too recently—within 30 days or longer, depending on how long the treatment stays in the body—or have already been assigned to a treatment group in this study.
  • Help plan or run this study, or the study doctor thinks you are unlikely to follow its rules and visits.
  • Be pregnant or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (235)

AL

AZ

CA

CO

DC

FL

GA

IA

ID

IL

IN

KS

KY

LA

MA

MD

MI

MO

MS

MT

NC

NE

NJ

NM

NV

NY

OH

OK

OR

PA

SC

SD

TN

TX

UT

VA

WA

WI

WV