NCT06678191Recruiting
Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting
Effectiveness of BDP/FF/G 172/5/9 Fixed Triple Combination on Symptom Scores in Asthma Patients After 6 Months Treatment
Source: ClinicalTrials.gov · Last updated 22 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The mainstay of asthma treatment are ICSs, mostly 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 authorisation 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. Also, there is scarcity of data regarding the phenotypes of asthmatics who benefit the most from the use of fixed triple combinations.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 9 Oct 2024
- Start date
- 24 Oct 2024
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Chiesi Hungary Ltd.
- NCT number
- NCT06678191
What you commit to
- Study type: Observational
- Planned participants: 800
- From 24 Oct 2024 to the primary completion date, 31 Oct 2026
- 45 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
- Continuous use of oral (\>5 mg prednisolone/day OR \>4 mg methylprednisolone/day) OR intravenous corticosteroids CHMED\_2024/01 Prof. Dr. Lilla Tamási 8(17)
- Use of continuous oxygen therapy
- Actual or previous use of biologics for asthma treatment in the past 12 months
Other illness
- Another respiratory condition, apart from asthma or COPD, that may interfere with the effectiveness of the treatment studied AND/OR another important clinical situation that may interfere with patient's compliance with the treatment.
- Any malignant disease in the last 5 years
- Tuberculosis (active or anamnestic)
Other
- All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC
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
- Uncontrolled asthma according to the physician's clinical assessment despite the use of
- LABA - high dose ICS OR
- LABA - high-dose ICS + LAMA multi-inhaler triple therapy for a minimum of three months.
- Patients who are eligible for the use of Trimbow 172/5/9 μg pMDI according to the SmPC and the financing protocol for asthma
- At least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months
- Uncontrolled asthma (ACT≤15)
- FEV1\<80% at baseline
- Inhaled asthma therapy was changed to Trimbow 172/5/9 μg pMDI no more than 1 week prior to OR on the day of study inclusion
- Patient provided written, informed consent to study participation
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (45)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Békés Megyei Központi Kórház, 2. Tüdőgyógyászat szakrendelés - 1. rendelés Coordinator of this site? Confirm its status | Békéscsaba | Hungary | Recruiting |
| Semmelweis Egyetem, Általános Orvostudományi Kar, Pulmonológiai Klinika Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Szent Kristóf Szakrendelő XI. Kerületi Tüdőgondozó Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Országos Korányi Pulmonológiai Intézet (OKPI) Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Kispesti Egészségügyi Intézet Tüdőgondozó, Ernyőképszűrő állomás Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| XVI. Kerület Kertvárosi Egészségügyi Szolgálata, Tüdőgyógyászat Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Szent Kristóf Szakrendelő XXII. Kerületi Tüdőgondozó Coordinator of this site? Confirm its status | Budapest | Hungary | Recruiting |
| Csornai Margit Kórház Tüdőbeteggondozó Intézet Coordinator of this site? Confirm its status | Csorna | Hungary | Recruiting |
| Debreceni Egyetem Klinikai Központ Allergológiai Szakrendelés Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Pulmonológiai Részleg Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| DE Klinikai Központ, Tüdőgyógyászati Klinika Coordinator of this site? Confirm its status | Debrecen | Hungary | Recruiting |
| SZTE SZAKK Deszki Multidiszciplináris Centrum Coordinator of this site? Confirm its status | Deszk | Hungary | Recruiting |
| Dunakeszi-SZTK Nonprofit Kft. Tüdőgyógyászat Coordinator of this site? Confirm its status | Dunakeszi | Hungary | Recruiting |
| Vaszary Kolos Kórház Tüdőgondozó Esztergom Coordinator of this site? Confirm its status | Esztergom | Hungary | Recruiting |
| Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház Coordinator of this site? Confirm its status | Fehérgyarmat | Hungary | Recruiting |
| Bugát Pál Kórház Tüdőbeteg Gondozó Intézet Coordinator of this site? Confirm its status | Gyöngyös | Hungary | Recruiting |
| Petz Aladar Megyei Oktato Korhaz Coordinator of this site? Confirm its status | Győr | Hungary | Recruiting |
| Békés Megyei Központi Kórház 1. Tüdőgyógyászat Szakrendelés Coordinator of this site? Confirm its status | Gyula | Hungary | Recruiting |
| Hajduböszörmény ESZ-V Nonprofit Kft Tüdőgyógyászat Coordinator of this site? Confirm its status | Hajdúböszörmény | Hungary | Recruiting |
| Tüdőgondozó / Szent Erzsébet Kórház Coordinator of this site? Confirm its status | Jászberény | Hungary | Recruiting |
| Szent Kereszt Kórház Kalocsa,Tüdőgyógyászati Szakrendelés Coordinator of this site? Confirm its status | Kalocsa | Hungary | Recruiting |
| Somogy Megyei Kaposi Mór Oktató Kórház Coordinator of this site? Confirm its status | Kaposvár | Hungary | Recruiting |
| Keszthelyi Kórház Tüdőgondozó Coordinator of this site? Confirm its status | Keszthely | Hungary | Recruiting |
| Kisteleki Egészségügyi Központi Nonprofit Kft. Coordinator of this site? Confirm its status | Kistelek | Hungary | Recruiting |
| Szent Damján Görögkatolikus Kórház Tüdőgyógyászati gondozó 1. Coordinator of this site? Confirm its status | Kisvárda | Hungary | Recruiting |
| Selye János Kórház Tüdőgyógyászati Szakellátás Coordinator of this site? Confirm its status | Komárom | Hungary | Recruiting |
| Kunszentmárton Városi Egészségügyi Központ Tüdőgyógyászat Coordinator of this site? Confirm its status | Kunszentmárton | Hungary | Recruiting |
| Szaplonczay Manó Marcali Kórház Tüdőgyógyászati Szakrendelés Coordinator of this site? Confirm its status | Marcali | Hungary | Recruiting |
| Mátrai Gyógyintézet Légzőszervi szakrendelés Coordinator of this site? Confirm its status | Mátraháza | Hungary | Recruiting |
| Karolina Kórház-Rendelőintézet Mosonmagyaróvár Coordinator of this site? Confirm its status | Mosonmagyaróvár | Hungary | Recruiting |
| Kanizsai Dorottya Korhaz Coordinator of this site? Confirm its status | Nagykanizsa | Hungary | Recruiting |
| Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház Coordinator of this site? Confirm its status | Nyírbátor | Hungary | Recruiting |
| Szabolcs-Szatmár- Bereg Megyei Kórházak és Egyetemi Oktatókórház Megyei-Városi Tüdőgondozó Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Recruiting |
| Orosházi Kórház Tüdőgondozó Coordinator of this site? Confirm its status | Orosháza | Hungary | Recruiting |
| Margit Kórház Pásztó Tüdőgyógyászati Szakrendelés Coordinator of this site? Confirm its status | Pásztó | Hungary | Recruiting |
| Egyesített Egészségügyi Intézmények Tüdőgondozó Coordinator of this site? Confirm its status | Pécs | Hungary | Recruiting |
| Sarkadi Kistérségi Járóbeteg Szakellátó Központ Coordinator of this site? Confirm its status | Sarkad | Hungary | Recruiting |
| Siófoki Kórház-Rendelőintézet Tüdőgondozó Coordinator of this site? Confirm its status | Siófok | Hungary | Recruiting |
| Csongrád Megyei Mellkasi Betegségek Szakkórháza, Tüdőgondozó Intézet Coordinator of this site? Confirm its status | Szeged | Hungary | Recruiting |
| Alba Szűrőközpont Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Recruiting |
| Fejér Megyei Szent György Egyetemi Oktató Kórház, Tüdőbeteg Gondozó, Városkörnyék I. Szakrendelés Székesfehérvár Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Recruiting |
| Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet Tüdőgyógyászati Szakrendelés Coordinator of this site? Confirm its status | Szolnok | Hungary | Recruiting |
| Markusovszky Egyetemi Oktatokorhaz Coordinator of this site? Confirm its status | Szombathely | Hungary | Recruiting |
| Református Pulmonológiai Centrum, Törökbálint Coordinator of this site? Confirm its status | Törökbálint | Hungary | Recruiting |
| Zala Megyei Szent Rafael Korhaz Coordinator of this site? Confirm its status | Zalaegerszeg | Hungary | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.