Triple therapy effectiveness in COPD patients with characteristics of asthma: A pragmatic primary care trial - The TRACkER trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28851

Enrollment

316

Registered

2019-12-11

Start date

2019-12-02

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD

Interventions

In the intervention group patients will use a single inhaler triple therapy (Trimbow), which includes a combination of beclomethasone dipropionate, formoterol fumarate dihydrate, and glycopyrronium br

Eligibility

Inclusion criteria

Inclusion criteria: - Physician diagnosis of COPD (documented obstruction or obstruction measured at the first study visit) - Age 40 years and older - Symptomatic (defined as Clinical COPD Questionnaire score ? 1) - ICS-naive (last 12 months no ICS containing treatment) - Usage of a long-acting bronchodilator; either usage of a single LABA or LAMA, usage of a single LABA and a single LAMA, or a usage of a single LABA/LAMA inhaler. Patients are allowed to use short-acting bronchodilator. - Blood eosinophils =100 cells per µL - One or more characteristics of asthma according to GOLD 2019 (age of onset, pattern of respiratory symptoms, history/family of asthma, history of Atopy).

Exclusion criteria

Exclusion criteria: - Chronic oral corticosteroid, use more than 60 days in the last 3 months - Recent exacerbation (last 6 weeks before inclusion) - Life expectancy of less than 2 years - Allergy to intervention formulation - Inability to understand Dutch - Any other condition which, at the GPs and/or investigator’s discretion, is believed to present a safety risk or may impact the study results - Patients participating in another ongoing clinical trial that in the investigator’s opinion influences the current study (e.g. another randomized controlled trial) - In ability to understand and sign the written consent form.

Design outcomes

Primary

Measure	Time frame
To investigate the effectiveness of triple therapy (ICS/LABA/LAMA) on the change in health status, measured with the Clinical COPD Questionnaire (CCQ), in symptomatic ICS-naive COPD patients with characteristics of asthma according to GOLD 2019 (age of onset, pattern of respiratory symptoms, history/family of asthma, history of Atopy) and blood eosinophil counts of =100 cells per µL compared to treatment with dual therapy (LABA/LAMA), within a primary care population. Effectiveness is regarded as difference in the proportion of patients a with minimal clinically improvement on health status (CCQ improvement =0.4) between the study groups.	—

Measure

Time frame

To investigate the effectiveness of triple therapy (ICS/LABA/LAMA) on the change in health status, measured with the Clinical COPD Questionnaire (CCQ), in symptomatic ICS-naive COPD patients with characteristics of asthma according to GOLD 2019 (age of onset, pattern of respiratory symptoms, history/family of asthma, history of Atopy) and blood eosinophil counts of =100 cells per µL compared to treatment with dual therapy (LABA/LAMA), within a primary care population. Effectiveness is regarded as difference in the proportion of patients a with minimal clinically improvement on health status (CCQ improvement =0.4) between the study groups.

—

Secondary

Measure	Time frame
- To identify patient and disease characteristics that are predictive for triple therapy effectiveness. Effectiveness is defined as improvement in CCQ of =0.4 from baseline to follow-up.The patient and disease characteristics that will be assessed are the following: 1) Patient demographics and disease history; 2) Symptoms of asthma as defined by GOLD 2019; 3) Blood test outcome measures (specific IgE and eosinophil counts); 4) Spirometry outcome measures; 5) Fractional exhaled nitric oxide (FeNO) levels; 6) Asthma Control Questionnaire (ACQ); 7) Small Airways Dysfunction Test (SADT) - To compare the number of moderate and severe exacerbations before (6 months) and during the study (6 months) between the study groups. - To investigate the difference in the pneumonia incidences between the study groups - To compare the proportion of net responders (positive responders (=0.4 improvement on the CCQ) minus negative responders (=0.4 decline on the CCQ)) between the study groups. - To compare the proportion of patients with clinically relevant improvement on either one or both, the CCQ (=0.4) or the ACQ (=0.5). - To compare the properties of the CCQ and the COPD Assessment Test (CAT) over the study period. - To compare the difference in lung function measures, Eos and FeNO between the study groups. - To describe patient reported side effects using the Inhaled Corticosteroids side-effect Questionnaire Short Form (ICQ-S). - To collect health resource utilization data (e.g. exacerbations, hospitalizations) and investigate the difference in health resource use and costs between the study groups. - To investigate the differences in genome-wide expression of mRNA, MiRNA and methylation status in epithelial cells derived from nasal brushings between the study groups.	—

Measure

Time frame

- To identify patient and disease characteristics that are predictive for triple therapy effectiveness. Effectiveness is defined as improvement in CCQ of =0.4 from baseline to follow-up.The patient and disease characteristics that will be assessed are the following: 1) Patient demographics and disease history; 2) Symptoms of asthma as defined by GOLD 2019; 3) Blood test outcome measures (specific IgE and eosinophil counts); 4) Spirometry outcome measures; 5) Fractional exhaled nitric oxide (FeNO) levels; 6) Asthma Control Questionnaire (ACQ); 7) Small Airways Dysfunction Test (SADT) - To compare the number of moderate and severe exacerbations before (6 months) and during the study (6 months) between the study groups. - To investigate the difference in the pneumonia incidences between the study groups - To compare the proportion of net responders (positive responders (=0.4 improvement on the CCQ) minus negative responders (=0.4 decline on the CCQ)) between the study groups. - To compare the proportion of patients with clinically relevant improvement on either one or both, the CCQ (=0.4) or the ACQ (=0.5). - To compare the properties of the CCQ and the COPD Assessment Test (CAT) over the study period. - To compare the difference in lung function measures, Eos and FeNO between the study groups. - To describe patient reported side effects using the Inhaled Corticosteroids side-effect Questionnaire Short Form (ICQ-S). - To collect health resource utilization data (e.g. exacerbations, hospitalizations) and investigate the difference in health resource use and costs between the study groups. - To investigate the differences in genome-wide expression of mRNA, MiRNA and methylation status in epithelial cells derived from nasal brushings between the study groups.

—

Contacts

Public ContactJanwillem Kocks

GPRI

janwillem.kocks@gpri.nl+31 (0)50 2113898

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)