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New Real-World study tests triple inhaler for better asthma control

NCT ID NCT06786767

Symptom relief Sponsor: Chiesi Bulgaria 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 281 adults with asthma for 6 months to see if a triple-combination inhaler (BDP/FF/G) improves symptom control in everyday life. Participants had asthma for at least 3 years and were not well controlled on their current treatment. The main goal was to measure changes in the Asthma Control Test score, which rates how well asthma is managed.

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

281 people

The number who actually took part.

Started

Feb 2025

Finished

Jan 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

Patient inclusion will take place among patients having severe asthma at outpatient clinics in the selected and approved sites.

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: 1. Physician-confirmed clinical diagnosis of asthma according to GINA guidelines and treated for at least 3 years before inclusion 2. Patients ≥ 18 years of age in ambulatory care 3. Patients who are eligible for the use of Trimbow 172/5/9 μg pMDI according to the SmPC 1. patients who experienced one or more asthma exacerbation in the previous year AND 2. patients not adequately controlled according to the physician's clinical assessment despite the use of b1) LABA and high dose ICS OR b2) LABA and high-dose ICS + LAMA multi-inhaler triple therapy. FEV1\<80% at baseline. (spirometry performed at the visit 1 independently of the study or up to 30 days before the enrolment or within 3 days after Visit 1 is acceptable). 5\. Inhaled asthma therapy was changed to Trimbow 172/5/9 μg pMDI no more than 2 weeks prior to OR on the day of study inclusion 6. Patient provided written, informed consent to study participation Exclusion Criteria: 1. Participation in any clinical trial within 30 days prior to enrolment 2. Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment. 3. Diagnosis of COPD. 4. Tuberculosis (active or anamnestic) 5. Actual or previous use of biologics for asthma treatment in the past 12 months 6. All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC 7. Hypersensitivity to the active substances or to any of the excipients listed in the SmPC 8. Pregnancy and lactation.

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Conditions

The condition(s) this trial relates to.

asthma

As listed by the trial registrant

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

Asthma Asthma bronchiale Asthma patients

Contacts and locations

Locations

  • AIPSACA Dr. Talyat Cholak

    Razgrad, Bulgaria

  • AIPSMC Dr. Svetlan Mihaylov

    Stara Zagora, Bulgaria

  • AIPSMCPP Dr. Bilyana Ivanova

    Vratsa, Bulgaria

  • AIPSMCPP Dr. Elina Smilkova

    Blagoevgrad, Bulgaria

  • AIPSMCPP Dr. Nikolay Lichev V. Tarnovo

    Veliko Tarnovo, Bulgaria

  • ASIMPIDPP Dr. Veselin Kalfov

    Haskovo, Bulgaria

  • Group practice for specialized medical care - Asthma Center Pleven

    Pleven, Bulgaria

  • IPASMC Dr. Kostadinka Sotirova

    Pazardzhik, Bulgaria

  • MHAT Svoge

    Svoge, Bulgaria

  • Medical Center Denitza

    Montana, Bulgaria

  • Medical Center Hipocrat

    Gabrovo, Bulgaria

  • Medical Center St. Ivan Rilski

    Vidin, Bulgaria

  • Medical Center Third Policlinic

    Stara Zagora, Bulgaria

  • Medical Center Viva Phenix

    Dobrich, Bulgaria

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