Clinical trials / NCT06678191
Recruiting

Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting

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…

ClinicalTrials.gov IDNCT06678191
PhaseNot Applicable
Enrollment800
SponsorChiesi Hungary Ltd.
Age18 Years
SexALL
I'm interested View official listing

Conditions studied

Asthma, Chronic Obstructive Pulmonary Disease (COPD), Asthma Bronchiale

About this study

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.

Interventions

Primary outcomes

Eligibility information

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

Study locations

Showing 10 of 45 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.