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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 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, willing to sign a consent form to study participation Who Should NOT Join This Trial: - 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 - 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 - All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
INCLUSION CRITERIA: * 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 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: * 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 * 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 * All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC

Treatments Being Tested

DRUG

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.

Locations (20)

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
Hajduböszörmény ESZ-V Nonprofit Kft Tüdőgyógyászat
Hajdúböszörmény, Hungary
Tüdőgondozó / Szent Erzsébet Kórház
Jászberény, Hungary