Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting
NCT ID: NCT06678191
Last Updated: 2024-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
800 participants
OBSERVATIONAL
2024-10-24
2027-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting
NCT06786767
Observational Study on Therapy Pathways of Asthamics Treated With ICS/LABA/LAMA Therapy in a Real-world Setting
NCT06100042
TRIple in asthMA With uncontRolled pAtient on Medium streNgth of ICS + LABA
NCT02676076
Utilization of Fixed Combination (Budesonide/Formoterol and Salmeterol/Fluticasone and Beclomethasone/Formoterol) in Treatment of Asthma Patients
NCT01327001
Triple in Asthma Dose Finding
NCT02127866
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Dosage regimen and administration Name of the product: Trimbow 172 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution (henceforth abbreviated as Trimbow 172/5/9 μg pMDI). Each delivered dose (the dose leaving the mouthpiece) contains 172 μg of beclometasone dipropionate, 5 μg of formoterol fumarate dihydrate and 9 μg of glycopyrronium (as 11 μg glycopyrronium bromide). Each metered dose (the dose leaving the valve) contains 200 μg of beclometasone dipropionate, 6 μg of formoterol fumarate dihydrate and 10 μg of glycopyrronium (as 12.5 μg glycopyrronium bromide). The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily.
1. Aim of the study (research objective)
Primary objective:
The main objective is to assess the effectiveness of BDP/FF/G 172/5/9 μg fixed triple combination in a real-world setting, with regards to improvements in symptom scores (ACT).
2. Test sample and method, recruitment principle No patient recruitment will be performed. Eligible patients will be enrolled during the participating physicians' regular asthma patient management and patients' written informed consent. Patient inclusion will take place among patients having severe asthma and attending pulmonology outpatient clinics (the chosen study sites are attached as annexes to the study protocol), strictly at the time of the patients' visit. The planned number of patients is 800.
3. Structure of the study In accordance with the requirements of non-interventional studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be made independently of the study, and patients should only be considered for inclusion in the study after a prior therapeutic decision has been made by a pulmonologist. Patient enrolment can take place after the patient has been fully informed about the purpose of the study and all of its details, and the patient has read and signed the patient information leaflet and patient consent form, including any questions they may have. Once this has taken place, the data that would have been generated anyway during the outpatient examination of the patient in accordance with daily practice can be recorded. This is considered the first visit of the study (Visit 1). During this visit, the patient's main demographic data, information on comorbidities and concomitant medications, previous and current asthma therapies, asthma specific assessment (including ACT), exacerbation history, post-dose lung function values (if spirometry data is available), laboratory results (if a laboratory test is performed during the visit or was performed recently), results of other medical examinations (e.g., chest X-ray) if performed regardless of the study, maintenance and reliever inhaled \& non-inhaled therapies (former and new) baseline quality of life based on the asthma quality of life (EQ-5D-5L) questionnaire, and adherence to therapy based on Test of Adherence to Inhalers® (TAI-12) questionnaire are recorded. Patients will then attend two additional visits 30 days and 6 months after enrolment as per routine clinical practice (Visits 2 and 3). During these visits, data will also be recorded, once again, according to routine clinical practice. Assessing the usage of rescue medications and patient adherence are also planned with the use of electronic health record system (EESZT)-verified prescription dispensations (optional for investigators). Visit 4 will be a long-term follow-up to assess the exploratory endpoint of exacerbations rates.
If the patient's maintenance therapy changes during the study as decided by the treating pulmonologist, and the patient is no longer receiving Trimbow 172/5/9 μg pMDI, the patient will be automatically excluded from this NIS. The fact of the therapy modification and its exact date must be recorded on the "current medication" form in the eCRF (electronic Case Report Form) of the next visit. If the change in therapy is related to a suspected adverse reaction, it should be reported separately on the eCRF platform in accordance with section 9 of this protocol ('Collection, recording and reporting of medication safety data').
This NIS is open to all eligible patients according to the inclusion and exclusion criteria. Permitted concomitant treatments: allowed all medications according to local clinical practice (any non-inhalation therapy for asthma or other diseases) and reliever (short-acting bronchodilators) inhaled therapies for asthma. The data to be recorded will be detailed in the study data sheet that forms part of the protocol. The data is recorded in the eCRF (MrAgent - Medisol Development Ltd., see also at 10.1.) system, with consideration to the current professional and legal regulations.
4. Start and duration of the study The first patient enrolment will take place after receiving approval from the National Public Health Center (NPHC), based on a beneficial assessment of the Medical Research Council of Hungary. The study is planned to start on September 16, 2024. Accordingly, first patient first visit (FPFV) is also planned to take place in September, 2024. The launch of the participating centres is planned in two waves, in the autumn of 2024 and in the spring of 2025. Each centre will have 12 months to enrol patients. After the last visit of the last patient (LPLV), centres will have one month to collect all missing data / correct any data flagged as queries during monitoring. Thus, the LPLV will take place on Oct 31, 2026 (primary endpoint) and 30 April, 2027 (exploratory endpoint), respectively. The study is planned to be concluded on August 31, 2027.
5. Data to be recorded during the visits A total of 4 visits will be performed for the assessment of the primary and secondary endpoints during the study. The table below summarises the data collection to be carried out during the visits separately. The patient may be enrolled in the study and their data may only be recorded, if these data would also have been recorded in accordance with standard medical practice.
* Visit 1: Time of enrolment - a normal visit, according to routine clinical practice. Informed consent and baseline patient characteristics will be collected.
* Visit 2: 1 month after enrolment (± 2-3 workdays)
* Visit 3: 6 months after enrolment (± 5-7 workdays)
* Visit 4: 12 months after enrolment (± 10-15 days)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Asthmatic patients switched to Trimbow (BDP/FF/G 172/5/9 μg)
Asthmatic patients who had been switched to BDP/FF/G 172/5/9 μg before study enrollment, due to uncontrolled asthma.
BDP/FF/G (Beclomethasone diprprionate, formoterol fumarate, glycopyrronium bromide) 172/5/9 μg
In accordance with the requirements of non-interventional studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be made independently of the study, and patients should only be considered for inclusion in the study after a prior therapeutic decision has been made by a pulmonologist.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BDP/FF/G (Beclomethasone diprprionate, formoterol fumarate, glycopyrronium bromide) 172/5/9 μg
In accordance with the requirements of non-interventional studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be made independently of the study, and patients should only be considered for inclusion in the study after a prior therapeutic decision has been made by a pulmonologist.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients ≥ 18 years of age in ambulatory care
* Uncontrolled asthma according to the physician's clinical assessment despite the use of
1. LABA - high dose ICS OR
2. 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
1. At least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months
2. Uncontrolled asthma (ACT≤15)
3. 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
Exclusion Criteria
* Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment
* 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.
* 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
* Any malignant disease in the last 5 years
* Tuberculosis (active or anamnestic)
* Actual or previous use of biologics for asthma treatment in the past 12 months
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chiesi Hungary Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hajduböszörmény ESZ-V Nonprofit Kft Tüdőgyógyászat
Hajdúböszörmény, , Hungary
Tüdőgondozó / Szent Erzsébet Kórház
Jászberény, , Hungary
Békés Megyei Központi Kórház, 2. Tüdőgyógyászat szakrendelés - 1. rendelés
Békéscsaba, , Hungary
Kispesti Egészségügyi Intézet Tüdőgondozó, Ernyőképszűrő állomás
Budapest, , Hungary
Országos Korányi Pulmonológiai Intézet (OKPI)
Budapest, , Hungary
Semmelweis Egyetem, Általános Orvostudományi Kar, Pulmonológiai Klinika
Budapest, , Hungary
Szent Kristóf Szakrendelő XI. Kerületi Tüdőgondozó
Budapest, , Hungary
Szent Kristóf Szakrendelő XXII. Kerületi Tüdőgondozó
Budapest, , Hungary
XVI. Kerület Kertvárosi Egészségügyi Szolgálata, Tüdőgyógyászat
Budapest, , Hungary
Csornai Margit Kórház Tüdőbeteggondozó Intézet
Csorna, , Hungary
DE Klinikai Központ, Tüdőgyógyászati Klinika
Debrecen, , Hungary
Debreceni Egyetem Kenézy Gyula Egyetemi Kórház Pulmonológiai Részleg
Debrecen, , Hungary
Debreceni Egyetem Klinikai Központ Allergológiai Szakrendelés
Debrecen, , Hungary
SZTE SZAKK Deszki Multidiszciplináris Centrum
Deszk, , Hungary
Dunakeszi-SZTK Nonprofit Kft. Tüdőgyógyászat
Dunakeszi, , Hungary
Vaszary Kolos Kórház Tüdőgondozó Esztergom
Esztergom, , Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
Fehérgyarmat, , Hungary
Bugát Pál Kórház Tüdőbeteg Gondozó Intézet
Gyöngyös, , Hungary
Petz Aladár Megyei Oktató Kórház
Győr, , Hungary
Békés Megyei Központi Kórház 1. Tüdőgyógyászat Szakrendelés
Gyula, , Hungary
Szent Kereszt Kórház Kalocsa,Tüdőgyógyászati Szakrendelés
Kalocsa, , Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, , Hungary
Keszthelyi Kórház Tüdőgondozó
Keszthely, , Hungary
Kisteleki Egészségügyi Központi Nonprofit Kft.
Kistelek, , Hungary
Szent Damján Görögkatolikus Kórház Tüdőgyógyászati gondozó 1.
Kisvárda, , Hungary
Selye János Kórház Tüdőgyógyászati Szakellátás
Komárom, , Hungary
Kunszentmárton Városi Egészségügyi Központ Tüdőgyógyászat
Kunszentmárton, , Hungary
Szaplonczay Manó Marcali Kórház Tüdőgyógyászati Szakrendelés
Marcali, , Hungary
Mátrai Gyógyintézet Légzőszervi szakrendelés
Mátraháza, , Hungary
Karolina Kórház-Rendelőintézet Mosonmagyaróvár
Mosonmagyaróvár, , Hungary
Kanizsai Dorottya Kórház
Nagykanizsa, , Hungary
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház
Nyírbátor, , Hungary
Szabolcs-Szatmár- Bereg Megyei Kórházak és Egyetemi Oktatókórház Megyei-Városi Tüdőgondozó
Nyíregyháza, , Hungary
Orosházi Kórház Tüdőgondozó
Orosháza, , Hungary
Margit Kórház Pásztó Tüdőgyógyászati Szakrendelés
Pásztó, , Hungary
Egyesített Egészségügyi Intézmények Tüdőgondozó
Pécs, , Hungary
Sarkadi Kistérségi Járóbeteg Szakellátó Központ
Sarkad, , Hungary
Siófoki Kórház-Rendelőintézet Tüdőgondozó
Siófok, , Hungary
Csongrád Megyei Mellkasi Betegségek Szakkórháza, Tüdőgondozó Intézet
Szeged, , Hungary
Alba Szűrőközpont
Székesfehérvár, , Hungary
Fejér Megyei Szent György Egyetemi Oktató Kórház, Tüdőbeteg Gondozó, Városkörnyék I. Szakrendelés Székesfehérvár
Székesfehérvár, , Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelőintézet Tüdőgyógyászati Szakrendelés
Szolnok, , Hungary
Markusovszky Egyetemi Oktatókórház
Szombathely, , Hungary
Református Pulmonológiai Centrum, Törökbálint
Törökbálint, , Hungary
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, , Hungary
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Árpád Vincze, Dr.
Role: primary
Brigitta Dombai, Dr.
Role: primary
Zsuzsanna Csoma, Dr.
Role: primary
Lilla Tamási, Prof.
Role: primary
Ildikó Nádudvary, Dr.
Role: primary
Lívia Medek, Dr.
Role: primary
Éva Tót, Dr.
Role: primary
Zoltán Bártfai, Dr
Role: primary
László Brúgos, Dr
Role: primary
Réka Keszthelyi, Dr.
Role: primary
Erzsébet Takács, Dr.
Role: primary
Klára Szalontay, Dr.
Role: primary
Katalin Kontz, Dr.
Role: primary
Gabriella Horváth, Dr.
Role: primary
Sándor Tóth, Dr.
Role: primary
Csilla Szabó, Dr
Role: primary
Márta Czompó, Dr.
Role: primary
Árpád Vincze, Dr
Role: primary
Gabriella Kiss, Dr.
Role: primary
Ida Nagy, dr.
Role: primary
Szabolcs Körmendy, Dr.
Role: primary
Éva Kuczkó, Dr.
Role: primary
Sándor Tehenes, Dr.
Role: primary
Ágnes Selypes, Dr.
Role: primary
Miklós Kukuly, Dr.
Role: primary
Judit Schlezák, Dr.
Role: primary
Tibor Süveges, Dr.
Role: primary
Jakoob Maha, Dr.
Role: primary
Magdolna Horváth, Dr.
Role: primary
Erika Unger, Dr.
Role: primary
Magdolna Tankó, Dr.
Role: primary
Krisztina Alb, Dr.
Role: primary
Ildikó Kerényi, Dr.
Role: primary
Erika Vecsey, Dr.
Role: primary
Margit Füleki, Dr.
Role: primary
Ágnes Varga, Dr
Role: primary
István Lopusnyik, Dr.
Role: primary
Anna Bartha, Dr.
Role: primary
László Makk, Dr
Role: primary
Zsolt Vidák, Dr.
Role: primary
Nóra Ferenczy, Dr.
Role: primary
Tibor Juhász, Dr.
Role: primary
Krisztina Hajdú, Dr.
Role: primary
Csilla Farkas, Dr.
Role: primary
Márta Beke, Dr.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CHMED_2024/01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.