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

CompletedN/A

Sponsor: Chiesi Bulgaria

Conditions: Asthma, Asthma Patients, Asthma Bronchiale

Interventions: BDP/FF/G (Beclomethasone diprprionate, formoterol fumarate, glycopyrronium bromide) 172/5/9 μg

Countries: Bulgaria

The mainstay of asthma treatment are ICSs, mostly and usually combined with LABA. In the past decade LAMA had been accepted as an add-on treatment for patients on GINA treatment 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 authorization 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 quality of life.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Physician-confirmed clinical diagnosis of asthma according to GINA guidelines and treated for at least 3 years before inclusion
2. Patients ≥ 18 years of age in ambulatory care
3. Patients who are eligible for the use of Trimbow 172/5/9 μg pMDI according to the SmPC

   1. patients who experienced one or more asthma exacerbation in the previous year AND
   2. patients not adequately controlled according to the physician's clinical assessment despite the use of b1) LABA and high dose ICS OR b2) LABA and high-dose ICS + LAMA multi-inhaler triple therapy. FEV1\<80% at baseline. (spirometry performed at the visit 1 independently of the study or up to 30 days before the enrolment or within 3 days after Visit 1 is acceptable).

5\. Inhaled asthma therapy was changed to Trimbow 172/5/9 μg pMDI no more than 2 weeks prior to OR on the day of study inclusion 6. Patient provided written, informed consent to study participation

Exclusion Criteria:

1. Participation in any clinical trial within 30 days prior to enrolment
2. Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment.
3. Diagnosis of COPD.
4. Tuberculosis (active or anamnestic)
5. Actual or previous use of biologics for asthma treatment in the past 12 months
6. All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC
7. Hypersensitivity to the active substances or to any of the excipients listed in the SmPC
8. Pregnancy and lactation.

Locations (14)

Blagoevgrad, Bulgaria
Dobrich, Bulgaria
Gabrovo, Bulgaria
Haskovo, Bulgaria
Montana, Bulgaria
Pazardzhik, Bulgaria
Pleven, Bulgaria
Razgrad, Bulgaria
Stara Zagora, Bulgaria
Stara Zagora, Bulgaria
Svoge, Bulgaria
Veliko Tarnovo, Bulgaria
Vidin, Bulgaria
Vratsa, Bulgaria