Fact CheckerSign in

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

Full criteria on ClinicalTrials.gov

Sites (14)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AIPSMCPP Dr. Elina Smilkova
Coordinator of this site? Confirm its status
BlagoevgradBulgariaUnknown status
Medical Center Viva Phenix
Coordinator of this site? Confirm its status
DobrichBulgariaUnknown status
Medical Center Hipocrat
Coordinator of this site? Confirm its status
GabrovoBulgariaUnknown status
ASIMPIDPP Dr. Veselin Kalfov
Coordinator of this site? Confirm its status
HaskovoBulgariaUnknown status
Medical Center Denitza
Coordinator of this site? Confirm its status
MontanaBulgariaUnknown status
IPASMC Dr. Kostadinka Sotirova
Coordinator of this site? Confirm its status
PazardzhikBulgariaUnknown status
Group practice for specialized medical care - Asthma Center Pleven
Coordinator of this site? Confirm its status
PlevenBulgariaUnknown status
AIPSACA Dr. Talyat Cholak
Coordinator of this site? Confirm its status
RazgradBulgariaUnknown status
Medical Center Third Policlinic
Coordinator of this site? Confirm its status
Stara ZagoraBulgariaUnknown status
AIPSMC Dr. Svetlan Mihaylov
Coordinator of this site? Confirm its status
Stara ZagoraBulgariaUnknown status
MHAT Svoge
Coordinator of this site? Confirm its status
SvogeBulgariaUnknown status
AIPSMCPP Dr. Nikolay Lichev V. Tarnovo
Coordinator of this site? Confirm its status
Veliko TarnovoBulgariaUnknown status
Medical Center St. Ivan Rilski
Coordinator of this site? Confirm its status
VidinBulgariaUnknown status
AIPSMCPP Dr. Bilyana Ivanova
Coordinator of this site? Confirm its status
VratsaBulgariaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.