Health Trials

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • BDP/FF/G (Beclomethasone diprprionate, formoterol fumarate, glycopyrronium bromide) 172/5/9 μg

Treatment groups

800 Participants
are divided into 1 treatment group

Locations

45
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

Sponsors and collaborators

Chiesi Hungary Ltd.

Lead sponsor

Source ClinicalTrials.gov