Health TrialsbyHealthPanel

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

ConditionAsthma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChiesi Poland Sp. z o.o.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

Adult asthmatic patients

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Trimbow

    Other intervention

    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.

Treatment groups

No treatment groups listed

Trial outcomes

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

Time frame
12 months

Secondary outcomes

1

Assess asthma control (ACT)

\- Assess asthma control (ACT) - Change from baseline in ACT scores

Time frame
12 months
2

Assess quality of life To measure the functional impairments

\- Assess quality of life - Change from baseline in Mini-AQLQ scores

Time frame
12 months
3

Treatment adherence

\- Assess treatment adherence - Change from baseline in TAI scores

Time frame
12 months
4

Lung function

\- Analyse parameters of lung function using spirometry - Change from baseline in FEV1

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chiesi Poland Sp. z o.o.

Lead sponsor

Gesellschaft für Therapieforschung mbH

Collaborator

Source ClinicalTrials.gov
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