Evaluating the effectiveness of a fixed triple inhaled combination for asthma patients
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
This study is testing if a new inhaler combination can help asthma patients who aren't well-controlled on their current treatments feel better over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chiesi Bulgaria Industry-sponsored |
| Locations | 15 sites (Blagoevgrad and 14 other locations) |
| Trial ID | NCT06786767 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the real-world effectiveness of the fixed triple inhaled combination of beclometasone dipropionate, formoterol fumarate, and glycopyrronium bromide (Trimbow) in patients with asthma. It will evaluate changes in symptom scores over a six-month period after switching from previous asthma treatments. The study will involve multiple centers across the country and will focus on patients who have been inadequately controlled on their current therapies. The primary outcome will be the improvement in the Asthma Control Test (ACT) scores.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of asthma who have been treated for at least three years and are not adequately controlled on their current medications.
Not a fit: Patients who have not experienced asthma exacerbations in the past year or those who are adequately controlled on their current asthma therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for improved asthma management and quality of life for patients using the fixed triple inhaled combination.
How similar studies have performed: Other studies have shown success with similar fixed triple inhaled combinations, but this study focuses on real-world effectiveness, which is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Blagoevgrad and 14 other locations
- AIPSMCPP Dr. Elina Smilkova — Blagoevgrad, Bulgaria (Recruiting)
- Medical Center Viva Phenix — Dobrich, Bulgaria (Recruiting)
- Medical Center Hipocrat — Gabrovo, Bulgaria (Recruiting)
- ASIMPIDPP Dr. Veselin Kalfov — Haskovo, Bulgaria (Recruiting)
- Medical Center Denitza — Montana, Bulgaria (Recruiting)
- IPASMC Dr. Kostadinka Sotirova — Pazardzhik, Bulgaria (Recruiting)
- Group practice for specialized medical care - Asthma Center Pleven — Pleven, Bulgaria (Recruiting)
- AIPSACA Dr. Talyat Cholak — Razgrad, Bulgaria (Recruiting)
- AIPSMC Dr. Svetlan Mihaylov — Stara Zagora, Bulgaria (Recruiting)
- Medical Center Third Policlinic — Stara Zagora, Bulgaria (Recruiting)
- MHAT Svoge — Svoge, Bulgaria (Recruiting)
- DCC St. Klementina — Varna, Bulgaria (Recruiting)
- AIPSMCPP Dr. Nikolay Lichev V. Tarnovo — Veliko Tarnovo, Bulgaria (Recruiting)
- Medical Center St. Ivan Rilski — Vidin, Bulgaria (Recruiting)
- AIPSMCPP Dr. Bilyana Ivanova — Vratsa, Bulgaria (Recruiting)
Study contacts
- Study coordinator: Neli L. Rodopska, Pharm. M.Sc.
- Email: n.rodopska@chiesi.com
- Phone: +359888528128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.