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Real-World study tracks COPD patients on triple therapy

NCT ID NCT05862545

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 250 adults with COPD who were starting a new triple-combination inhaler (budesonide/glycopyrronium/formoterol, or BGF) in routine Italian clinics. Researchers measured how patients felt about their health after 12 weeks and up to a year. The goal was to see real-world improvements in symptoms and quality of life, not to test a cure.

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

250 people

The number who actually took part.

Started

Jun 2023

Finished

May 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

The study population consists of adult patients with moderate to severe COPD who are eligible for BGF therapy, enrolled consecutively by physicians in specialist setting. The decision to start treatment with BGF must be made by the treating physician according to the subjects' medical need and a positive benefit/risk balance. The decision to prescribe BGF must be independent of enrolment into the study, must be determined by the treating physician and should be taken according to the standard of current best medical practice and national guidelines.

Ages

40 to 120 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: 1. Male or female, aged \>= 40; 2. Physician-diagnosed COPD; 3. Signed written informed and privacy consent prior to study participation; 4. Patients starting treatment with BGF as prescribed according to the label, local market reimbursement criteria, and AIFA Nota 99; 5. Patients must be able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol. Exclusion Criteria: 1. COPD due to documented α-1 antitrypsin deficiency; 2. Patients with controlled COPD treated with triple fixed-dose combination in 12 months prior to screening visits; 3. Hospitalisation due to COPD exacerbation within the last 30 days prior to enrolment; 4. Pregnancy or lactation period; 5. 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, observational or clinical trial in the last 30 days prior to enrolment.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease lung disorder

As listed by the trial registrant

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

Chronic obstructive pulmonary disease

Contacts and locations

Locations

  • Research Site

    Acquaviva delle Fonti, Italy

  • Research Site

    Alessandria, Italy

  • Research Site

    Ancona, Italy

  • Research Site

    Avellino, Italy

  • Research Site

    Brescia, Italy

  • Research Site

    Brindisi, Italy

  • Research Site

    Busto Arsizio (Varese), Italy

  • Research Site

    Catania, Italy

  • Research Site

    Catanzaro, Italy

  • Research Site

    Cittadella (Padova), Italy

  • Research Site

    Florence, Italy

  • Research Site

    Foggia, Italy

  • Research Site

    Lecce, Italy

  • Research Site

    Naples, Italy

  • Research Site

    Passirana (Milano), Italy

  • Research Site

    Pavia, Italy

  • Research Site

    Roma, Italy

  • Research Site

    Torino, Italy

  • Research Site

    Treviso, Italy

  • Research Site

    Verona, Italy

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