Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)
Recruiting · NCT07489911 · Observational (researchers observe without assigning treatment) · Lead sponsor: Chiesi Slovenija, d.o.o.
View the official record on ClinicalTrials.gov →Interventions studied
BDP/FF/G (beclometasone dipropionate/formoterol fumarate dihydrate/glycopyrronium) 172/5/9 μg
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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:
- LABA and high dose ICS or
- 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 :
- at least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months
- uncontrolled asthma (ACT≤15) or partially controlled asthma (15\<ACT\<20)
- 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
Where it is running
18 locations listed.
- 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
- Zdravstveni Dom Koper Casa Della Sanita Capodistria - Koper, Slovenia
- MEDICOINTERNA, medicinske storitve in svetovanje, d.o.o. - Kočevje, 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
- MEDI PULMO, interna medicina, d.o.o. - Ljubljana, Slovenia
- OBJEM ZDRAVJA zdravstveno svetovalni center d.o.o. - Ljubljana, Slovenia
- PULMEDICO, specialistična zdravstvena dejavnost, d.o.o. - Ljubljana, Slovenia
- ALVEOLA internistični ambulantni diagnostični center d.o.o. - Maribor, Slovenia
- Zasebna Ambulanta Za Pljučne Bolezni, Mag. Alojz Horvat, Dr. Med. Specialist Interne Medicine - Murska Sobota, Slovenia
- EUPNEA d.o.o. - Murska Sobota, Slovenia
- Zasebna Internistično-Pulmološka Ambulanta, Jasmina Panjan Avramovič, Dr.Med.Spec. - Portorož, Slovenia
- Zdravstveni Dom Tolmin - Tolmin, Slovenia
- Zdravstveni Zavod Pulmoradix Velenje - Velenje, Slovenia
- DLAN, pomoč in nega na domu, specialistična zdravstvena dejavnost, Lucija Gabršček Parežnik s.p. - Šentjur pri Celju, Slovenia