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

Chronic Obstructive Pulmonary Disease Clinical Trial

— INCLINE  

Official title:

An Observational Cohort Study of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05814484
• Other study ID #: 0884
• Status: Not yet recruiting
• Start date: August 10, 2023
• Est. completion date: January 2025

Study information

• Verified date: July 2023
• Source: University of Leicester
• Contact: Hnin WW Aung, MBBS
• Phone: +447949813009
• Email: hwwa1[@]leicester.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: January 2025
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adherence, Treatment
• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United Kingdom	NIHR Biomedical Research Centre, University of Leicester	Leicester	Leicestershire

Sponsors (2)

Lead Sponsor	Collaborator
University of Leicester	Aparito Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total number of exacerbation events	All exacerbation events during study period	24 weeks
Secondary	Number of participants who successfully completed the trial digital tasks	Participants who filled out electronic questionnaires and weekly symptom diaries	Month 6
Secondary	Feasibility of digital platform	Number of exacerbation events captured by digital platform	Month 6
Secondary	Change in blood eosinophil count over time	Peripheral blood eosinophil count	Month 1, 2,4 & 6
Secondary	Change in lung function test	Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1)	Month 0 & 6
Secondary	Change in score of St George's Respiratory Questionnaire (SGRQ)	This 50-item questionnaire measures health status (quality of life) in patients with diseases of airway obstruction. Scores are broken down into 'symptoms' (normal participant range 9-15), 'activity' (normal participant range 7-12), 'impacts' (normal participant range 1-3), and a total score (normal participant range 5-7). Higher scores indicate poorer health status.	Month 0,2,4 & 6
Secondary	Change in score of COPD Assessment Tool (CAT)	The COPD Assessment Test (CAT) is a questionnaire for people with Chronic Obstructive Pulmonary Disease (COPD). It is designed to measure the impact of COPD on a person's life, and how this changes over time. Scores range from 0-40, with higher scores indicating greater impact of COPD on a patient's life.	Month 0,2,4 & 6
Secondary	Change in Extended MR dyspnoea score (eMRC)	This scale measures perceived respiratory disability. Participants rate their grades of breathlessness on a scale of 1 (least) to 5 (worst). The extension divides the grade 5 rating into 'a' (independent) and 'b' (dependent) to establish dependence on others for washing and dressing.	Month 0,2,4 & 6
Secondary	Number of exacerbation events	To compare between T2H and non T2H groups regardless of adherence level	Month 6
Secondary	Changes in blood eosinophil count	Comparison between nonT2high and T2high subgroups regardless of adherence rate	Month 1,2,4 & 6