Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChiesi Hungary Ltd.
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
This trial does not accept healthy volunteersQualifiers
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 population
Asthma patients treated at GINA step 5, uncontrolled with ICS-LABA, containing high dose ICS.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
BDP/FF/G (Beclomethasone diprprionate, formoterol fumarate, glycopyrronium bromide) 172/5/9 μg
DrugIn 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.
Treatment groups
800 Participants
are divided into 1 treatment groupGroup A: Asthmatic patients switched to Trimbow (BDP/FF/G 172/5/9 μg)1 intervention
Trial outcomes
Primary outcomes
1
Asthma control Test
Change (improvement) of asthma control test (ACT) score, during the 6 months of treatment (Visit 3), compared to the score at baseline.
Time frame
6 months2
Asthma control Test 2
• The percentage of patients achieving an improvement in asthma control test (ACT) score of 3 points (MCID, minimum clinically important difference) or more, after the 6 months treatment (Visit 3) compared to baseline.
Time frame
6 monthsSecondary outcomes
1
Asthma control test change
The percentage of patients achieving an improvement according to asthma control levels (uncontrolled= ACT ≤15; partially controlled= 15\<ACT\<20; controlled 20≤ACT)
Time frame
6 months2
HRQoL
Change in Health-related QoL was assessed by measuring the 5-level EuroQoL 5-dimension component (EQ-5D-5L) index score at Visit 3 (6 months), compared to the baseline visit 1 (Week 0), regarding the assessment of the impact of Asthma on the patient's quality of life.
Time frame
6 months3
Adherence
Change in Test of Adherence to Inhalers® (TAI-12) score at Visit 3 (6 months) compared to baseline visit (Visit 1, week 0) regarding adherence to treatment with use of the Trimbow 172/5/9 μg pMDI.
Time frame
6 months4
Lung function
Change in spirometric parameters: FEV1, FVC, FEV1/FVC, at Visit 3 (6 months), compared to the baseline Visit 1 (Week 0), with use of the Trimbow 172/5/9 μg pMDI.
Time frame
6 monthsOther outcomes
1
Exacerbations
Changes in moderate and severe exacerbation rates at Visit 4 (12 months), compared to the baseline Visit 1 (Week 0), with use of the Trimbow 172/5/9 μg pMDI
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov