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
Chiesi Hungary Ltd.
800 participants
Oct 24, 2024
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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
Exclusion Criteria8
- 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
Interventions
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(45)
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NCT06678191