Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChiesi Slovenija, d.o.o.
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 at GINA 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 adherence.
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
LABA and high dose ICS or
LABA and high-dose ICS + LAMA multi-inhaler triple therapy for a minimum of three months.
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
Trial population
Asthma patients treated at GINA step 5, uncontrolled/ partially controlled with ICS+LABA, containing high dose ICS.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
BDP/FF/G (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium) 172/5/9 μg
Drugextrafine SITT
Treatment groups
200 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
Test of Adherence to Inhalers (TAI)
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 months3
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 monthsSponsors and contacts
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Source ClinicalTrials.gov