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Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)

Recruitingn/aAges 18 Years - anyAllChiesi Slovenija, d.o.o.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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 and high dose ICS or 2. LABA and 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 : 1. at least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months 2. uncontrolled asthma (ACT≤15) or partially controlled asthma (15\<ACT\<20) 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 * 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
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What it tests

  • BDP/FF/G (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium) 172/5/9 μg
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Where

18 sites
AMBULANTA ARIA, specialistična ambulanta za alergijske in pljučne bolezni, d.o.o.
Celje, Slovenia
Dr. ŠEGOTA - PULMOLOG, specialistične zdravstvene storitve, d.o.o.
Celje, Slovenia
Internistična Ambulanta Za Pljučne in Alergijske Bolezni - Karmen Kramer Vrščaj Dr. Med.
Celje, Slovenia
MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o.
Kočevje, Slovenia
Zdravstveni Dom Koper Casa Della Sanita Capodistria
Koper, Slovenia
VELOG Zdravstveni center d.o.o.
Kranj, Slovenia
ARJANA MAČEK, zdravstvene in druge storitve, d.o.o
Ljubljana, Slovenia
KAMBIČ - KAFOL, medicinsko svetovanje in storitve, d.o.o.
Ljubljana, Slovenia

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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