NCT05728749

Brief Summary

TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

March 3, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

February 6, 2023

Last Update Submit

July 4, 2023

Conditions

ASTHMA

Keywords

ASTHMATRIMBOWTRIPLE THERAPYBECLOMETHASONEFORMOTEROLGLYCOPYRRONIUMTRIMAXIMIZEREAL-WORLD SETTINGEXTRAFINESINGLE-INHALERCOHORTPROSPECTIVE

Outcome Measures

Primary Outcomes (1)

  • To describe patient characteristics and therapy pathways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice

    Descriptive analysis of patient demographics.

    12 months

Secondary Outcomes (13)

  • Assess asthma control (ACT)

    12 months

  • Assess quality of life

    12 months

  • Assess treatment adherence

    12 months

  • Analyse parameters of lung function using spirometry

    12 months

  • Analyse parameters of small airways disease

    12 months

  • +8 more secondary outcomes

Study Arms (1)

Asthma patients

Trimbow pMDI prescribed for maintenance treatment of adult asthma as per the licensed indication.

Other: Non-interventional

Interventions

Non-interventionalOTHER

As this is a non-interventional trial, only data obtained within the current routine management of asthma at outpatient respiratory centres or GP centres will be documented.

Asthma patients

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAdult, Older Adult
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients will only be included in the Non-Interventional Trial if Trimbow® has been prescribed in line with its current marketing authorisation and the guidance specified in the summary of product characteristics (SmPC). Physicians are urged to offer enrolment to all of their eligible patients consecutively as they present for their routine visit, and not select patients from their patient database. Eligible patients may only be included in the NIT after providing written (witnessed, where required by law or regulation), IEC-approved informed consent.

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,
  • Patient must be covered by a social security scheme,
  • Patient must be treated by one of the practitioners of the centre (at office or at hospital).

You may not qualify if:

  • 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.
  • Patients unable to understand scope of study or patients unwilling to participate in study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChiesiFrance

Bois-Colombes, 92270, France

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Arnaud BOURDIN, Pr

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine CONTRE, Dr

CONTACT

+33675085149c.contre@chiesi.com

Justine FIOCCA, Pharm.D

CONTACT

+33785823381j.fiocca@chiesi.com

Study Design

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

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 15, 2023

Study Start

March 3, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2025

Last Updated

July 6, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)