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

Launched by UNIVERSITY OF LEICESTER · Apr 12, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how well people with Chronic Obstructive Pulmonary Disease (COPD) use their inhalers and how this affects their blood eosinophil counts during flare-ups of their condition. A flare-up, or exacerbation, is when symptoms worsen and may require additional treatment. Over six months, researchers will monitor inhaler use using special sensors that connect to mobile apps, along with collecting information about symptoms and flare-ups mostly through remote check-ins. The goal is to see if this digital approach can help better track treatment adherence and flare-up occurrences in real life.

To participate, individuals must be at least 18 years old and have a confirmed diagnosis of COPD, along with a history of frequent flare-ups (two or more requiring significant treatment in the past year). Participants should also be using a specific combination of medications called triple therapy for at least four weeks prior to the study. Those who can’t use a smartphone or have certain health conditions or recent trial participation may not be eligible. By joining this study, participants will contribute to understanding how technology can aid in managing COPD more effectively.

Gender

ALL

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.