TRACkER trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

General Practitioners Research Institute B.V.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

completed 19 Feb 2024

Decision date (initial)

2023-10-24

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Chiesi Pharmaceuticals B.V.

External identifiers

EU CT number

2023-508300-37-00

EudraCT number

2019-003351-11

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy

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 and blood eosinophil counts of ≥100 cells per μL compared to treatment with dual therapy (LABA/LAMA), within a primary care population.

Secondary objectives 12

1. To identify patient and disease characteristics that are predictive for triple therapy effectiveness.
2. To compare the number of moderate and severe exacerbations before (6 months) and during the study (6 months) between the study groups.
3. To investigate the difference in the pneumonia incidences between the study groups.
4. 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
5. To compare the proportion of patients with clinically relevant improvement on either one or both, the CCQ (≥0.4) or the ACQ (≥0.5).
6. To compare the properties of the CCQ and the COPD Assessment Test (CAT) over the study period.
7. To compare the difference in lung function measures, Eos and FeNO between the study groups.
8. To describe patient reported side effects using the Inhaled Corticosteroids side-effect Questionnaire Short Form (ICQ-S).
9. To collect health resource utilisation data (e.g. exacerbations, hospitalisations) and investigate the difference in health resource use and costs between the study groups.
10. 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.
11. To validate the role of matrix proteins in the pathological processes in COPD to identify therapeutic targets for intervention and examine their utility as biomarkers for monitoring and predicting disease progression and/or treatment response between the study groups.
12. To investigate whether presence of a single nucleotide polymorphisms (SNPs) or combination of SNPs can a) help to predict if COPD patients respond favorably to ICS, and b) influence expression level of a COPD relevant gene, i.e. are expression quantitative trait loci.

Conditions and MedDRA coding

Chronic Obstructive Pulmonary Disease (COPD)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Physician diagnosis of COPD (documented obstruction or obstruction measured at the first study visit)
2. Age 40 years and older
3. Symptomatic (defined as Clinical COPD Questionnaire score ≧ 1)
4. ICS-naive (last 12 months no ICS containing treatment)
5. 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 a short-acting bronchodilator.
6. Blood eosinophils ≥100 cells per μL AND one or more characteristics of asthma according to GOLD 2019.

Exclusion criteria 8

1. Chronic oral corticosteroid, use more than 60 days in the last 3 months, except for prescriptions during a Covid infection
2. Recent exacerbation (last 6 weeks before inclusion)
3. Life expectancy of less than 2 years
4. Allergy to intervention formulation
5. Inability to understand national language.
6. Any other condition which, at the physician’s and/or investigator’s discretion, is believed to present a safety risk or may impact the study results
7. Patients participating in another ongoing clinical trial that in the investigator’s opinion influences the current study (e.g. another randomized controlled trial)
8. Inability to understand and sign the written consent form.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary outcome of this study is the difference in the proportion of patients with a clinically relevant improvement in health status (≥0.4 improvement on the CCQ) between the triple therapy group and LABA/LAMA treatment groups at the end of the 26 weeks intervention period.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

General Practitioners Research Institute B.V.

Sponsor organisation

General Practitioners Research Institute B.V.

Address

Professor Enno Dirk Wiersmastraat 5

City

Groningen

Postcode

9713 GH

Country

Netherlands

Scientific contact point

Organisation

General Practitioners Research Institute B.V.

Contact name

Researchers Tracker study team

Public contact point

Organisation

General Practitioners Research Institute B.V.

Contact name

Researchers Tracker study team

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Application history

1 submissions — initial application plus substantial / non-substantial modifications