Clinical trial NCT05814484: Role of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of COPD
Official title: An Observational Cohort Study of Inhaler Adherence and Blood Eosinophil Count in Exacerbations of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Obstructive Pulmonary Disease
Adherence, Treatment
Keywords: Blood Eosinophil Count
Exacerbation
Lead sponsor: University of Leicester
Sponsor class: OTHER
Collaborators: name: Aparito Ltd.
First posted: 2023-04-14
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: COPD patients with frequent exacerbation events

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.

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.

Primary outcomes:
measure: Total number of exacerbation events
timeFrame: 24 weeks
Secondary outcomes:
measure: Number of participants who successfully completed the trial digital tasks
timeFrame: Month 6
measure: Feasibility of digital platform
timeFrame: Month 6
measure: Change in blood eosinophil count over time
timeFrame: Month 1, 2,4 & 6
measure: Change in lung function test
timeFrame: Month 0 & 6
measure: Change in score of St George's Respiratory Questionnaire (SGRQ)
timeFrame: Month 0,2,4 & 6
measure: Change in score of COPD Assessment Tool (CAT)
timeFrame: Month 0,2,4 & 6
measure: Change in Extended MR dyspnoea score (eMRC)
timeFrame: Month 0,2,4 & 6
measure: Number of exacerbation events
timeFrame: Month 6
measure: Changes in blood eosinophil count
timeFrame: Month 1,2,4 & 6
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: NIHR Biomedical Research Centre, University of Leicester
state: Leicestershire
Study officials:
affiliation: University of Leicester, Biomedical Research Centre, Respiratory Science
name: Neil Greening
role: PRINCIPAL_INVESTIGATOR
References: