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

NCT07489911

RecruitingN/A

Sponsor: Chiesi Slovenija, d.o.o.

Conditions: Asthma, Asthma Patients, Asthma Bronchiale

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

Countries: Slovenia

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
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
Locations (18)
  • Celje, Slovenia
  • Celje, Slovenia
  • Celje, Slovenia
  • Kočevje, Slovenia
  • Koper, Slovenia
  • Kranj, Slovenia
  • Ljubljana, Slovenia
  • Ljubljana, Slovenia
  • Ljubljana, Slovenia
  • Ljubljana, Slovenia
  • Ljubljana, Slovenia
  • Maribor, Slovenia
  • Murska Sobota, Slovenia
  • Murska Sobota, Slovenia
  • Portorož, Slovenia
  • Šentjur pri Celju, Slovenia
  • Tolmin, Slovenia
  • Velenje, Slovenia