Clinical trial NCT06283966: A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: COPD (Chronic Obstructive Pulmonary Disease)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 5000
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.

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

Primary outcomes:
measure: Time to first severe cardiac or COPD event
timeFrame: Up to 3 years
Secondary outcomes:
measure: Time to first severe COPD exacerbation event
timeFrame: Up to 3 years
measure: Time to first severe cardiac event
timeFrame: Up to 3 years
measure: Time to cardiopulmonary death
timeFrame: Up to 3 years
measure: Moderate/severe COPD exacerbation rate
timeFrame: Over time, up 3 years
measure: Time to Myocardial Infarction (MI) hospitalization or cardiac death
timeFrame: Up to 3 years
measure: Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death
timeFrame: Up to 3 years
Other outcomes:
measure: Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death
timeFrame: Up to 3 years
Locations:
city: Athens
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state: Alabama
city: Cullman
country: United States
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state: Alabama
city: Fairhope
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state: Alabama
city: Huntsville
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city: Lomita
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state: California
city: Newport Beach
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state: California
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city: North Hollywood
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city: Tarzana
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city: Englewood
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city: Boynton Beach
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city: Bradenton
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city: Orlando
country: United States
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city: Ormond Beach
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city: Pembroke Pines
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city: Plantation
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city: Saint Petersburg
country: United States
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city: Sun City Center
country: United States
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state: Florida
city: Tamarac
country: United States
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city: Atlanta
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state: Georgia
city: Peachtree Corners
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state: Georgia
city: Savannah
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city: Tucker
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city: Toms River
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city: Bronxville
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city: Bronx
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city: Brooklyn
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city: Massapequa
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city: New Windsor
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state: New York
city: New York
country: United States
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state: New York
city: New York
country: United States
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state: New York
city: Vestal
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city: Fayetteville
country: United States
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state: North Carolina
city: Greensboro
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state: North Carolina
city: Greenville
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state: North Carolina
city: Huntersville
country: United States
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state: North Carolina
city: Morehead City
country: United States
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state: North Carolina
city: Raleigh
country: United States
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state: North Carolina
city: Salisbury
country: United States
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state: North Carolina
city: Statesville
country: United States
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state: North Carolina
city: Statesville
country: United States
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state: North Carolina
city: Wilmington
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state: North Carolina
city: Winston-Salem
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state: North Carolina
city: Beavercreek
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state: Ohio
city: Blue Ash
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city: Cleveland
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city: Columbus
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city: Columbus
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city: Marion
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city: Norman
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city: Oklahoma City
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city: Tulsa
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city: Grants Pass
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state: Oregon
city: Medford
country: United States
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city: Roseburg
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city: DuBois
country: United States
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city: Exton
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Philadelphia
country: United States
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state: Pennsylvania
city: Anderson
country: United States
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state: South Carolina
city: Charleston
country: United States
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state: South Carolina
city: Charleston
country: United States
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state: South Carolina
city: Columbia
country: United States
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state: South Carolina
city: Gaffney
country: United States
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state: South Carolina
city: Spartanburg
country: United States
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state: South Carolina
city: Union
country: United States
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state: South Carolina
city: Pierre
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state: South Dakota
city: Rapid City
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state: South Dakota
city: Sioux Falls
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state: South Dakota
city: Chattanooga
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state: Tennessee
city: Elizabethton
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city: Salt Lake City
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country: United States
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city: Cudahy
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city: Milwaukee
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country: Argentina
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city: Buenos Aires
country: Argentina
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city: Buenos Aires
country: Argentina
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city: Buenos Aires
country: Argentina
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city: Buenos Aires
country: Argentina
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city: Caba
country: Argentina
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city: Capital Federal
country: Argentina
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city: Florencio Varela
country: Argentina
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city: Florida
country: Argentina
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city: Mar del Plata
country: Argentina
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city: Mendoza
country: Argentina
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city: Ranelagh
country: Argentina
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city: Rosario
country: Argentina
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country: Argentina
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country: Argentina
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city: Tucumán
country: Argentina
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Australia
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country: Austria
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city: Braunau
country: Austria
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city: Feldbach
country: Austria
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city: Graz
country: Austria
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city: Wien
country: Austria
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city: Belo Horizonte
country: Brazil
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city: Belo Horizonte
country: Brazil
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country: Brazil
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country: Brazil
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country: Brazil
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country: Brazil
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country: Brazil
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country: Brazil
facility: Research Site
city: Campina Grande do Sul
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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country: Bulgaria
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
city: Iloilo City
country: Philippines
facility: Research Site
city: Las Pinas
country: Philippines
facility: Research Site
city: Mabalacat
country: Philippines
facility: Research Site
city: Manadaluyong City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Marilao
country: Philippines
facility: Research Site
city: Puerto Princesa City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Roxas City
country: Philippines
facility: Research Site
city: Tondo
country: Philippines
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Chojnice
country: Poland
facility: Research Site
city: Chęciny
country: Poland
facility: Research Site
city: Inowrocław
country: Poland
facility: Research Site
city: Karczew
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Kraków
country: Poland
facility: Research Site
city: Libiąż
country: Poland
facility: Research Site
city: Lubin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Ostrowiec Świętokrzyski
country: Poland
facility: Research Site
city: Piaseczno
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Płock
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Sieradz
country: Poland
facility: Research Site
city: Sochaczew
country: Poland
facility: Research Site
city: Sosnowiec
country: Poland
facility: Research Site
city: Sosnowiec
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Słupsk
country: Poland
facility: Research Site
city: Toruń
country: Poland
facility: Research Site
city: Ustroń
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Warszawa
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Leamna de Sus
country: Romania
facility: Research Site
city: Negresti-Oas
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Timisoara
country: Romania
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Nis
country: Serbia
facility: Research Site
city: Novi Sad
country: Serbia
facility: Research Site
city: Sremska Kamenica
country: Serbia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Brezno
country: Slovakia
facility: Research Site
city: Humenne
country: Slovakia
facility: Research Site
city: Kosice
country: Slovakia
facility: Research Site
city: Kráľovský Chlmec
country: Slovakia
facility: Research Site
city: Levice
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Topoľčany
country: Slovakia
facility: Research Site
city: Alicante
country: Spain
facility: Research Site
city: Badia Del Vallès
country: Spain
facility: Research Site
city: Barakaldo
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Castro Urdiales
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Madrid
country: Spain
facility: Research Site
city: Marbella (Málaga)
country: Spain
facility: Research Site
city: Mataro
country: Spain
facility: Research Site
city: Mataro
country: Spain
facility: Research Site
city: Málaga
country: Spain
facility: Research Site
city: Palma
country: Spain
facility: Research Site
city: Patraix
country: Spain
facility: Research Site
city: Santiago De Compostela-Coruña
country: Spain
facility: Research Site
city: Tenerife
country: Spain
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Göteborg
country: Sweden
facility: Research Site
city: Höllviken
country: Sweden
facility: Research Site
city: Kungsbacka
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Umeå
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Örebro
country: Sweden
facility: Research Site
city: Changhua County
country: Taiwan
facility: Research Site
city: Kao Hsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan City
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan City
country: Taiwan
facility: Research Site
city: Taoyuan
country: Taiwan
facility: Research Site
city: Yunlin
country: Taiwan
facility: Research Site
city: Bang Kra So
country: Thailand
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Hat Yai
country: Thailand
facility: Research Site
city: Khlong Luang
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Ongkharak
country: Thailand
facility: Research Site
city: Phitsanulok
country: Thailand
facility: Research Site
city: Ratchathewi
country: Thailand
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Adana
country: Turkey
facility: Research Site
city: Afyonkarahisar
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Canakkale
country: Turkey
facility: Research Site
city: Isparta
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: İstanbul
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Izmir
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Kocaeli
country: Turkey
facility: Research Site
city: Mersin
country: Turkey
facility: Research Site
city: Tekirdag
country: Turkey
facility: Research Site
city: Zeytinburnu
country: Turkey
facility: Research Site
city: Çankaya
country: Turkey
facility: Research Site
city: Chernivtsi
country: Ukraine
facility: Research Site
city: Chernivtsі
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Ivano-Frankivsk
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Ternopil
country: Ukraine
facility: Research Site
city: Uzhhorod
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Bicester
country: United Kingdom
facility: Research Site
city: Bollington
country: United Kingdom
facility: Research Site
city: Bradford
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Corby
country: United Kingdom
facility: Research Site
city: Cottingham
country: United Kingdom
facility: Research Site
city: Fowey
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Hounslow
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Newquay
country: United Kingdom
facility: Research Site
city: North Somerset
country: United Kingdom
facility: Research Site
city: Northallerton
country: United Kingdom
facility: Research Site
city: Norwich
country: United Kingdom
facility: Research Site
city: Nottingham
country: United Kingdom
facility: Research Site
city: Perth
country: United Kingdom
facility: Research Site
city: Poole
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Torbay
country: United Kingdom
facility: Research Site
city: Whitney
country: United Kingdom
facility: Research Site
city: Witney
country: United Kingdom
facility: Research Site
Study officials:
References: