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

NCT05814484 | Unknown DMC

• 1 other identifier: 0884
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Adherence, Treatment

Keywords

Blood Eosinophil Count; Exacerbation

Outcome Measures

Primary Outcomes (1)

• Total number of exacerbation events

  All exacerbation events during study period

  24 weeks

Secondary Outcomes (9)

• Number of participants who successfully completed the trial digital tasks

  Month 6

• Feasibility of digital platform

  Month 6

• Change in blood eosinophil count over time

  Month 1, 2,4 & 6

• Change in lung function test

  Month 0 & 6

• Change in score of St George's Respiratory Questionnaire (SGRQ)

  Month 0,2,4 & 6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

COPD patients with frequent exacerbation events

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Leicester: lead
• Aparito Ltd.: collaborator

Study Sites (1)

NIHR Biomedical Research Centre, University of Leicester

Leicester, Leicestershire, LE1 9QP, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Full Blood Count (Plasma, Serum) Nasopharyngeal swab Urine Sputum C Reactive Protein

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Neil Greening

  University of Leicester, Biomedical Research Centre, Respiratory Science

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hnin WW Aung, MBBS

CONTACT

+447949813009; hwwa1@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: April 14, 2023
• Study Start: August 10, 2023
• Primary Completion: November 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)