Role of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of COPD

NCT ID: NCT05814484

Last Updated: 2023-07-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2025-01-31

Brief Summary

This is an observational study examining inhaler adherence and subsequent changes in blood eosinophil count in exacerbations of Chronic obstructive pulmonary disease (COPD) population.

The study will run for 6 months as an observation period. Passive inhaler adherence monitoring will be done electronically via inhaler sensors connected to mobile Apps, and collecting symptoms questionnaires, diary of exacerbation events and trial visits predominantly in remote fashion. It will explore the feasibility of digital platform in clinical practice to collect the adherence data along with exacerbation events.

Detailed Description

How Chronic Obstructive Pulmonary Disease (COPD) affects patients varies greatly among individuals. The concept of treatable traits, which identifies factors within an individual to allow targeted treatment has altered management strategies. The most commonly used biomarker for exacerbations of COPD is the blood eosinophil count [BEC], which tends to indicate a higher risk of exacerbations, but importantly is a biomarker of treatment response for corticosteroids.

Current pharmacological treatment for COPD is predominately based around inhaled therapy in the form of bronchodilators and inhaled corticosteroids (ICS) therapy.

However, almost half of the COPD population have been shown to poorly follow the prescribed inhaled therapy. This is important as a non-adherent trait may impact on BEC and result in unnecessary treatment escalation, increased risk to higher risk individuals (e.g. patients with high BEC) and lack of intervention around inhaler adherence.

Recent developments of digital platforms could potentially address this by capturing objective adherence data, unrecorded exacerbation events or if possible, anticipating the latter.

In summary, it is important to align inhaler adherence in conjunction with established biomarker, as is likely to help gain maximum benefit and better target interventions. In this study, the investigators propose the electronic monitoring of adherence and exacerbation reporting data along with the reflected changes in biomarkers and disease outcomes to lead a meaningful treatable trait approach in real-life setting.

Conditions

Chronic Obstructive Pulmonary Disease; Adherence, Treatment

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of COPD documented by a health care provider with previous documented obstructive spirometry
• History of frequent exacerbations (defined as 2 or more exacerbations requiring oral corticosteroids and/or antibiotics within 12 months of pre-screening).
• Male or female participants aged ≥18 years.
• Willing and able to consent to participate in study.
• Able to use a smartphone device and comply with trial procedures.
• Participants with established triple therapy (ICS +LABA + LAMA) as controller at least 4 weeks prior to screening

Exclusion Criteria

• Unable to give informed consent.
• Unable to use a smartphone device.
• Current or within the last 6 months (or maximum relevant wash out period, whichever is longer), participation in an investigational medicinal product (IMP) or device trial at the time of screening.
• Use of maintenance systemic corticosteroids within last 30 days.
• Patients whose treatment is considered palliative (life expectancy <6 months).
• History of unstable or severe cardiac, hepatic, or renal disease, or other medically significant illness, which the investigator believes, would be a contraindication to study participation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aparito Ltd.

INDUSTRY

Sponsor Role: collaborator

University of Leicester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil Greening

Role: PRINCIPAL_INVESTIGATOR

University of Leicester, Biomedical Research Centre, Respiratory Science

Locations

NIHR Biomedical Research Centre, University of Leicester

Leicester, Leicestershire, United Kingdom

Countries

United Kingdom

Central Contacts

Hnin WW Aung, MBBS

Role: CONTACT

hwwa1@leicester.ac.uk

+447949813009

Other Identifiers

0884

Identifier Type: -

Identifier Source: org_study_id