NCT06786767Completed
Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting
A Prospective Non-interventional Real-world Study Assessing the Effectiveness of Extrafine BDP/FF/G (Beclometasone Dipropionate/Formoterol Fumarate/Glycopyrronium) 172/5/9 mcg, (Pressurised Inhalation, Solution) Single Inhaler Triple Therapy (SITT) on Symptom Scores in Asthma Patients After 6 Months Treatment
Source: ClinicalTrials.gov · Last updated 19 Mar 2026
Brief summary (registry, in English)
The mainstay of asthma treatment are ICSs, mostly and usually combined with LABA. In the past decade LAMA had been accepted as an add-on treatment for patients on GINA treatment Steps 4 and 5. Recently, RCTs proved the efficacy and safety of fixed triple combinations of moderate and high dose of ICS and LABA, LAMA in a very selected asthmatic population, resulting in the market authorization of these products. However, there is a lack of evidence on the real-world effectiveness of these therapies, especially with regards to improvement in symptom scores and quality of life.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 281 (actual)
- First submitted
- 16 Jan 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 5 Jan 2026
- Lead sponsor
- Chiesi Bulgaria
- Diseases
- Asthma
- NCT number
- NCT06786767
What you commit to
- Study type: Observational
- Participants enrolled: 281
- From 1 Feb 2025 to the primary completion date, 5 Jan 2026
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in any clinical trial within 30 days prior to enrolment
- Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.
- Actual or previous use of biologics for asthma treatment in the past 12 months
Other illness
- Tuberculosis (active or anamnestic)
- Hypersensitivity to the active substances or to any of the excipients listed in the SmPC
Other
- Diagnosis of COPD.
- All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC
- Pregnancy and lactation.
Who the study is looking for
- Physician-confirmed clinical diagnosis of asthma according to GINA guidelines and treated for at least 3 years before inclusion
- Patients ≥ 18 years of age in ambulatory care
- Patients who are eligible for the use of Trimbow 172/5/9 μg pMDI according to the SmPC
- patients who experienced one or more asthma exacerbation in the previous year AND
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AIPSMCPP Dr. Elina Smilkova Coordinator of this site? Confirm its status | Blagoevgrad | Bulgaria | Unknown status |
| Medical Center Viva Phenix Coordinator of this site? Confirm its status | Dobrich | Bulgaria | Unknown status |
| Medical Center Hipocrat Coordinator of this site? Confirm its status | Gabrovo | Bulgaria | Unknown status |
| ASIMPIDPP Dr. Veselin Kalfov Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Unknown status |
| Medical Center Denitza Coordinator of this site? Confirm its status | Montana | Bulgaria | Unknown status |
| IPASMC Dr. Kostadinka Sotirova Coordinator of this site? Confirm its status | Pazardzhik | Bulgaria | Unknown status |
| Group practice for specialized medical care - Asthma Center Pleven Coordinator of this site? Confirm its status | Pleven | Bulgaria | Unknown status |
| AIPSACA Dr. Talyat Cholak Coordinator of this site? Confirm its status | Razgrad | Bulgaria | Unknown status |
| Medical Center Third Policlinic Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Unknown status |
| AIPSMC Dr. Svetlan Mihaylov Coordinator of this site? Confirm its status | Stara Zagora | Bulgaria | Unknown status |
| MHAT Svoge Coordinator of this site? Confirm its status | Svoge | Bulgaria | Unknown status |
| AIPSMCPP Dr. Nikolay Lichev V. Tarnovo Coordinator of this site? Confirm its status | Veliko Tarnovo | Bulgaria | Unknown status |
| Medical Center St. Ivan Rilski Coordinator of this site? Confirm its status | Vidin | Bulgaria | Unknown status |
| AIPSMCPP Dr. Bilyana Ivanova Coordinator of this site? Confirm its status | Vratsa | Bulgaria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.