TriMaximize: A multicentre, prospective, non-interventional trial monitoring therapy pathways of Asthma patients treated with an extra-fine ICS/LABA/LAMA single-inhaler triple therapy in a real-world setting and characterizing the effects on health-related outcomes

Recruiting

Conditions: J45
Asthma

Registration Number: DRKS00024724

Lead Sponsor: Chiesi GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 3950

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

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.

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the primary objective (description of patient characteristics and therapy pathways) the following data are collected:<br>- Demographic data<br>- Medical history<br>- Asthma history<br>- Asthma treatment history<br>- Reason for treatment choice of fixed triple therapy<br>- Frequency of application of different strengths of fixed triple therapy<br>

Secondary Outcome Measures