J45
Conditions
Interventions
Group 1: Trimbow® 87 microgram/5 microgram /
9 microgram pressurized inhalation, solution
or
Trimbow® 172 microgram /5 microgram /
9 microgram pressurized inhalation, solution.
The dates for the vi
Sponsors
Chiesi GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients = 18 years of age, 2) Patients with confirmed leading diagnosis of asthma with or without concomitant COPD, 3) Physician decision to start fixed triple therapy with ICS/LABA/LAMA (Trimbow® MS or HS) according to its current authorised indication. The treatment decision must be made independently from participation in this NIS, 4) Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study.
Exclusion criteria
Exclusion criteria: 1) Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period. No further selection criteria apply, in order to enrol a population that is likely to reflect the current target population for ICS/LABA/LAMA combination therapy as per routine clinical practice.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the primary objective (description of patient characteristics and therapy pathways) the following data are collected: - Demographic data - Medical history - Asthma history - Asthma treatment history - Reason for treatment choice of fixed triple therapy - Frequency of application of different strengths of fixed triple therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change from baseline in ACT scores - Change from baseline in Mini-AQLQ scores - Change from baseline in TAI scores - Change from baseline in relevant lung function parameters (spirometry, body plethysmography) - Change from baseline in percentage of patients with low (200-400 ml) or high (above 400 ml) reversibility (FEV1) - Change from baseline in percentage of patients with persistant airway limitation (PAL); PAL defined as post-BD FEV1 <80% predicted and post-BD FEV1/FVC Ratio < 0.7 - Change from baseline in small airway function measured by pre-dose AUCAX (Area under the curve of reactance) using available oscillometry system - Change from baseline in percentage of patients with a fraction of exhaled nitric oxide (FeNO) below or above 20 ppb - Number and severity of exacerbations 12 months prior to baseline and during study - Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit - Use of any systemic corticosteroids 12 months prior to baseline and during study - Use of spacer - Number and type of adverse events - Use of asthma related healthcare resources 3 months prior to baseline and during study - Assessment of patient satisfaction with therapy - Continuation of treatment with Trimbow® (retention rate of Trimbow®) at month 12 and reason for discontinuation incl. follow-up therapy | — |
Countries
Austria, Denmark, France, Germany, Italy, Poland, Spain, United Kingdom
Contacts
Public ContactValentina Bogoevska
Chiesi GmbH
Outcome results
None listed