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Global study checks if triple inhaler really works for COPD patients

NCT ID NCT07069829

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 15, 2026 · Updated 5 times

Summary

This study follows 1,400 adults with moderate to severe COPD who are starting Breztri/Trixeo, a triple-combination inhaler. Researchers will track changes in symptoms and quality of life over 12 months in real-world clinics across Latin America, Asia, and the Middle East & Africa. The goal is to see how well the treatment works outside of controlled trials.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Breztri/Trixeo (a triple combination inhaler containing an inhaled corticosteroid, a long-acting beta-agonist, and a long-acting muscarinic antagonist)
What this could lead to
If successful, this study could show that Breztri/Trixeo improves quality of life and reduces symptoms in real-world COPD patients, supporting its use in routine care.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It does not test a new treatment, only gathers data on an existing one.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study plans to enroll approximately 1,400 patients, accounting for an expected dropout rate or missing data of \~20%, to ensure that at least 1,120 patients complete the study.

Ages

30 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: The study will include patients who were prescribed BGF, but not yet initiated, according to the label (SmPC) and local market reimbursement criteria. Patients will only be included in the study if they meet the following inclusion criteria: 1. Patients diagnosed with COPD, at least 12 months before baseline, as assessed per physician's routine practice or as documented in the patient's chart. 2. Male or female patients aged over 30 years and under 80 years at the time of enrolment. 3. Patients providing a written Informed Consent\* prior to inclusion to the study. \*Prescription of BGF should be prior to the signed informed consent and the decision to prescribe this therapy is clearly separated from the physician's decision to include the patient in the current study. 4. Patients able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol. Exclusion Criteria: Patients who meet any of the following criteria will not be eligible to participate in the study: 1. Patients with COPD due to documented α-1 antitrypsin deficiency. 2. Patients with recent (≤3 months) major cardiac or pulmonary events that required hospitalization (e.g., myocardial infarction, pulmonary embolism). 3. Patients previously treated with triple fixed-dose combination therapies 12 months before the screening visit or treated with Multiple Inhaled Triple Therapy (MITT) within the last 3 months before the screening visit. 4. Patients hospitalized due to COPD exacerbations within the last 30 days prior to enrolment. 5. Currently pregnant (or intending to become pregnant), breastfeeding, or lactating women. 6. Patients with a current diagnosis of asthma, active tuberculosis, lung cancer or lung metastasis, significant bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases, or other active clinically significant pulmonary diseases. 7. Patients currently participating in a non-interventional observational trial that might, in the investigator's opinion, influence the assessment for the current study or participation in any interventional trial in the last 30 days prior to enrolment. 8. Patients with respiratory tract infection (including COVID-19 infection) ) that has not resolved ≤30 days prior to BGF MDI initiation and those exhibiting persistent long-COVID symptoms are excluded from the study.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic obstructive pulmonary disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    36 sites in 12 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    NOT_YET_RECRUITING

    Buenos Aires, Argentina

  • Research Site

    NOT_YET_RECRUITING

    La Plata, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Mar del Plata, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Mendoza, Argentina

  • Research Site

    NOT_YET_RECRUITING

    Bogotá, Colombia, Colombia

  • Research Site

    NOT_YET_RECRUITING

    Medell N, Colombia, Colombia

  • Research Site

    NOT_YET_RECRUITING

    Barranquilla, Colombia

  • Research Site

    RECRUITING

    Rionegro, Colombia

  • Research Site

    RECRUITING

    Alexandria, Egypt

  • Research Site

    RECRUITING

    Cairo, Egypt

  • Research Site

    NOT_YET_RECRUITING

    Cairo, Egypt

  • Research Site

    RECRUITING

    Jawa Barat, Indonesia, Indonesia

  • Research Site

    NOT_YET_RECRUITING

    Jakarta, Indonesia

  • Research Site

    RECRUITING

    Jakarta, Indonesia

  • Research Site

    RECRUITING

    Amman, Jordan

  • Research Site

    NOT_YET_RECRUITING

    George Town, Malaysia, Malaysia

  • Research Site

    RECRUITING

    Kuala Selangor, Malaysia, Malaysia

  • Research Site

    RECRUITING

    Kuala Lumpur, Malaysia

  • Research Site

    NOT_YET_RECRUITING

    Kuching, Malaysia

  • Research Site

    NOT_YET_RECRUITING

    Malacca, Malaysia

  • Research Site

    NOT_YET_RECRUITING

    Guadalajara, Mexico

  • Research Site

    NOT_YET_RECRUITING

    Mexico City, Mexico

  • Research Site

    NOT_YET_RECRUITING

    Monterrey, Mexico

  • Research Site

    RECRUITING

    Abhā, Saudi Arabia

  • Research Site

    RECRUITING

    Riyadh, Saudi Arabia

  • Research Site

    NOT_YET_RECRUITING

    Riyadh, Saudi Arabia

  • Research Site

    RECRUITING

    Yunlin, Taiwan, Taiwan

  • Research Site

    RECRUITING

    Taichung, Taiwan

  • Research Site

    RECRUITING

    Tainan, Taiwan

  • Research Site

    RECRUITING

    Taipei, Taiwan

  • Research Site

    RECRUITING

    Bangkok, Thailand

  • Research Site

    RECRUITING

    Nonthaburi, Thailand

  • Research Site

    RECRUITING

    Dubai, United Arab Emirates

  • Research Site

    NOT_YET_RECRUITING

    Dubai, United Arab Emirates

  • Research Site

    RECRUITING

    Hà Nội, Vietnam, Vietnam

  • Research Site

    RECRUITING

    Ho Chi Minh City, Vietnam

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