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| ID | Type | Description | Link |
|---|---|---|---|
| NIS 005 Pn | Other Identifier | International unique identifier (Chiesi) | |
| 294788 | Other Identifier | IRAS |
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| Name | Class |
|---|---|
| Gesellschaft für Therapieforschung mbH | INDUSTRY |
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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).
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).
Trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclometasone).
Asthma patients often need to use multiple inhalers as part of their therapy, which require different inhalation techniques. It has been shown that the use of several inhalers of different mode of action, design and dosage requirements may have a detrimental effect on patient adherence and subsequent treatment outcomes.
In this prospective, non-interventional trial, the investigators aim to evaluate aspects of adherence to Trimbow, a single-inhaler triple therapy (SITT) as a maintenance treatment of asthma, to gather knowledge from routine care on whether appropriate step-up to SITT leads to greater adherence and better health outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma patients | Trimbow pMDI prescribed for maintenance treatment of adult asthma as per the licensed indication. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-interventional | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess asthma control (ACT) | Change from baseline in ACT scores | 12 months |
| Assess quality of life | Change from baseline in Mini-AQLQ scores |
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Inclusion 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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Russell, PhD, MBBS | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Haven Surgery, The Haven, Burnhope, | Durham | County Durham | DH7 0BD | United Kingdom |
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| 12 months |
| Assess treatment adherence | Change from baseline in TAI scores | 12 months |
| Analyse parameters of lung function using spirometry | Change from baseline in FEV1 | 12 months |
| Analyse parameters of small airways disease | Change from baseline in small airway function measured by pre-dose AUCAX (Area under the curve of reactance) using available oscillometry system | 12 months |
| Analyse parameters of asthma-related airway inflammation | Change from baseline in percentage of patients with a fraction of exhaled nitric oxide (FeNO) below or above 20 ppb | 12 months |
| Analyse parameters of persistent airflow limitation | Change from baseline in percentage of patients with persistent airflow limitation (PAL); PAL defined as post-BD FEV1 <80% predicted and post-BD FEV1/FVC Ratio < 0.7 | 12 months |
| Analyse the incidence of asthma exacerbations | Number of exacerbations 12 months prior to baseline and during study | 12 months |
| Analyse the severity of asthma exacerbations as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) classification of asthma exacerbations | Severity of exacerbations, defined according to the ATS/ERS classification of asthma exacerbations, will be analysed 12 months prior to baseline and during study | 12 months |
| Analyse use of rescue medication | Use of any rescue medication 7 days prior to baseline and during study 7 days prior to respective visit | 12 months |
| Analyse use of systemic corticosteroids | Use of any systemic corticosteroids 12 months prior to baseline and during study | 12 months |
| Assess adverse events associated with use of Trimbow | Assessment of the number and type of adverse events | 12 months |
| Assess retention rate with Trimbow | Assess continuation of treatment with Trimbow (retention rate of Trimbow) at month 12 | 12 months |
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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