TriMaximize: A Multicentre, Prospective, Non-interventional Trial in Asthma Patients

NCT06567977 | Recruiting

• 1 other identifier: NIS 005 Pn
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice.

  Primary outcome measures include: Descriptive analisys of patients demografic Descriptive analisys of patient demographic

  12 months

Secondary Outcomes (12)

• Assess asthma control (ACT)

  12 months

• Assess quality of life To measure the functional impairments

  12 months

• Treatment adherence

  12 months

• Lung function

  12 months

• Small airways parameters

  12 months

Interventions

Trimbow OTHER

Trimbow® is a fixed triple therapy containing a long-acting muscarinic antago-nist (LAMA, Glycopyrronium), a long-acting beta-adrenergic agonist (LABA, Formoterol) and an inhaled corticosteroid (ICS, beclomethasone). Trimbow® has an extra-fine formulation delivered as a controlled dosage aerosol. Trim-bow® is to be applied in accordance with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC) in each country.

Also known as: Trimbow®

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult asthmatic patients

You may qualify if:

• Patients ≥ 18 years of age,
• Patients with confirmed leading diagnosis of asthma with or without concomitant COPD,
• 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,
• Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study.

You may not qualify if:

• Participation in an interventional clinical trial within 30 days prior to en-rolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.

Sponsors & Collaborators

• Chiesi Poland Sp. z o.o.: lead
• Gesellschaft für Therapieforschung mbH: collaborator

Study Sites (1)

Indywidualna Specjalistyczna Praktyka Lekarska

Tarnowskie Góry, 42-609, Poland

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Tomasz Debowski, Md Phd

CONTACT

+48-800 506 122 982; t.debowski@chiesi.com

Maciej Wojakiewicz, Phd

CONTACT

+48-800 697 400 054; m.wojakiewicz@chiesi.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: August 23, 2024
• Study Start: August 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 23, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)