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Evaluating a new inhaler for COPD patients

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)

Phase 3 Interventional AstraZeneca · NCT06283966

This study is testing a new inhaler for people with COPD to see if it helps improve their lung health compared to a standard treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment5000 (estimated)
Ages40 Years to 80 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Locations920 sites (Athens, Alabama and 919 other locations)
Trial IDNCT06283966 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial aims to assess the efficacy of a combination inhaler containing Budesonide, Glycopyrronium, and Formoterol Fumarate on cardiopulmonary outcomes in patients with Chronic Obstructive Pulmonary Disease (COPD). Participants will be randomly assigned to receive either the new inhaler or a standard treatment inhaler over a specified period. The study will focus on individuals at elevated risk for cardiopulmonary events, with outcomes measured through various clinical assessments. The trial is designed to be double-blind to ensure unbiased results.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 to 80 with a confirmed diagnosis of COPD and a history of cardiovascular risk factors.

Not a fit: Patients without a history of smoking or those with mild COPD and no cardiovascular risk factors may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cardiopulmonary health and quality of life for COPD patients.

How similar studies have performed: Previous studies have shown promising results with similar combination therapies in COPD, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Athens, Alabama and 919 other locations

+870 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions COPD
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.