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New COPD drug shows promise in Real-World romanian study

NCT ID NCT06368427

Symptom relief Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study followed 10 people with moderate to severe COPD in Romania who started taking the inhaler TRIXEO AEROSPHERE. Researchers measured changes in their health status and treatment satisfaction over 3 and 6 months. The goal was to see how the medication works in everyday life, not in a controlled lab setting.

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

10 people

The number who actually took part.

Started

Apr 2024

Finished

Nov 2025

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

Patients with moderate to severe COPD who are eligible for BGF MDI therapy may be enrolled by physicians in the specialist care setting.

Ages

18 years and older

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: * Physician-diagnosed COPD * Initiated treatment with BGF MDI as prescribed according to the summary of product characteristics (SmPC) and local market reimbursement criteria; * Patients must be able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol * After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of, and the procedures required for the study and are willing to participate in the study Exclusion Criteria: * COPD due to known α-1 antitrypsin deficiency * Previous treatment with triple fixed-dose combination in 12 months prior to baseline * Hospitalization due to COPD exacerbation within the last 30 days prior to index date * Pregnancy or lactation period * Other uncontrolled disease, that might, in the investigator's opinion, influence the assessment for the current study * Participation 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 clinical trial in the last 30 days prior to baseline. * Hospitalization for Covid-19 infection in the last 30 days prior to index date

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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 (COPD)

Contacts and locations

Locations

  • Research Site

    Baia Mare, Romania

  • Research Site

    Bucharest, Romania

  • Research Site

    Cluj-Napoca, Romania

  • Research Site

    Constanța, Romania

  • Research Site

    Craiova, Romania

  • Research Site

    Deva, Romania

  • Research Site

    Dorohoi, Romania

  • Research Site

    Hunedoara, Romania

  • Research Site

    Iași, Romania

  • Research Site

    Luduş, Romania

  • Research Site

    Medgidia, Romania

  • Research Site

    Oradea, Romania

  • Research Site

    Sighișoara, Romania

  • Research Site

    Suceava, Romania

  • Research Site

    Târgu Mureş, Romania

  • Research Site

    Timișoara, Romania

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