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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06283966




Registration number
NCT06283966
Ethics application status
Date submitted
21/02/2024
Date registered
28/02/2024

Titles & IDs
Public title
A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
Scientific 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)
Secondary ID [1] 0 0
D5989C00001
Universal Trial Number (UTN)
Trial acronym
THARROS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD (Chronic Obstructive Pulmonary Disease) 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BGF MDI 320/14.4/9.6 µg
Treatment: Drugs - GFF MDI 14.4/9.6 µg

Experimental: BGF arm - BGF MDI 320/14.4/9.6 µg BID

Experimental: GFF arm - GFF MDI 14.4/9.6 µg BID


Treatment: Drugs: BGF MDI 320/14.4/9.6 µg
Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension

Treatment: Drugs: GFF MDI 14.4/9.6 µg
Glycopyrronium and formoterol fumarate pressurized inhalation suspension
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first severe cardiac or COPD event
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [1] 0 0
Time to first severe COPD exacerbation event
Timepoint [1] 0 0
Up to 3 years
Secondary outcome [2] 0 0
Time to first severe cardiac event
Timepoint [2] 0 0
Up to 3 years
Secondary outcome [3] 0 0
Time to cardiopulmonary death
Timepoint [3] 0 0
Up to 3 years
Secondary outcome [4] 0 0
Moderate/severe COPD exacerbation rate
Timepoint [4] 0 0
Over time, up 3 years
Secondary outcome [5] 0 0
Time to Myocardial Infarction (MI) hospitalization or cardiac death
Timepoint [5] 0 0
Up to 3 years
Secondary outcome [6] 0 0
Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death
Timepoint [6] 0 0
Up to 3 years

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/03/2028
Actual
Sample size
Target
5000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Cairns
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Research Site - Chermside
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Research Site - Spearwood
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Research Site - St Albans
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Research Site - Taringa
Recruitment postcode(s) [1] 0 0
4870 - Cairns
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4032 - Chermside
Recruitment postcode(s) [3] 0 0
02450 - Coffs Harbour
Recruitment postcode(s) [4] 0 0
6163 - Spearwood
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3021 - St Albans
Recruitment postcode(s) [6] 0 0
4068 - Taringa
Recruitment outside Australia
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Witney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available to whom?
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06283966