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
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
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 design
Treatments tested in this trial
- BDP/FF/G (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium) 172/5/9 μg
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov