Can a single triple inhaler tame asthma in the real world?
NCT ID NCT06100042
First seen Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time
Summary
This study follows adults with asthma whose doctors have prescribed a single-inhaler triple therapy combining an anti-inflammatory steroid, a long-acting bronchodilator, and an anticholinergic. Researchers will collect data from routine care visits to see how well the treatment controls symptoms and affects daily life. The goal is to understand how this inhaler performs outside of controlled trial settings.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- An extrafine single-inhaler triple therapy containing beclomethasone, formoterol, and glycopyrronium (BDP/FF/G), known as Trimbow
- What this could lead to
- If the data show good asthma control in routine care, it could support wider use of this triple therapy and help doctors tailor treatment for individual patients.
- What could go wrong
- This is an observational study, not a controlled experiment, so it cannot prove cause and effect. Results may be influenced by patient differences and real-world variability.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
-
233 people
The number who actually took part.
- Started
-
Apr 2024
- Finished
-
Jun 2026
- 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
Adult patients with a diagnosis of moderate to severe asthma treated with BDP/FF/G as per clinical practice.
- 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 Hide 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: * Patients ≥ 18 years of age; * Patients with confirmed leading diagnosis of asthma with or without concomitant COPD; * Physician decision to start fixed triple therapy with ICS/LABA/LAMA (BDP/FF/G) MS or HS according to its current authorised indication and current reimbursement conditions within the Italian National Health System. The treatment decision must be made independently from participation in this study and may have started within the previous 4 weeks (maximum); * Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study. Exclusion Criteria: * Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
U.O. Clinica Psichiatrica e SPDC. Ospedale Policlinico S. Martino - IRCCS, Genova
Genoa, Italy
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