Chronic obstructive pulmonary disease (COPD) Respiratory
Conditions
Interventions
Current interventions as of 17/01/2025:
This is a pragmatic real-life study which does not involve any study visits outside routine care. All patient contact and visits during the study will be part
COPD002 is part of a nationally available Quality and Outcomes Framework Indicator for COPD (a marker for achievement of COPD patient care). Sites will be randomised in 1:1 ratio to the control arm or
Sponsors
Observational and Pragmatic Research International Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 17/01/2025: For a practice to be eligible for participation, the following criteria should be met: 1. General practice in the United Kingdom (England, Scotland, Wales, Northern Ireland) participating in Optimum Patient Care services that support chronic disease review and provide high-quality respiratory data 2. Willing to use advanced technology as part of clinical practice 3. At least 8 patients suitable for adherence technology 4. Actively prescribing Ultibro® Breezehaler® as a routine clinical care option; (i.e. inhaler compatible with the add-on technology) ASA arm patients included in the study: 1. Aged =40 years 2. COPD diagnosis 3. =2 exacerbations in the last 2 years or 2 years preceding March 2020 4. Prescribed maintenance inhaled COPD therapy in the last 12 months 5. 2 years’ valid EMR data 6. Pharmacist deemed patient to be clinically suitable and poorly adherent to inhaled therapy (according to EMR, self-report or clinical judgement) Control arm patients included in the study: 1. Matched to intervention patients based on LABA/LAMA prescription date 2. Aged =40 years 3. COPD diagnosis 4. =2 exacerbations in the last 2 years or 2 years preceding March 2020 5. Prescribed maintenance inhaled COPD therapy in the last 12 months 6. 2 years’ valid EMR data _____ Previous inclusion criteria as of 06/09/2023: For a practice to be eligible for participation, the following criteria should be met: 1. General practice in the United Kingdom (England, Scotland, Wales, Northern Ireland) participating in Optimum Patient Care services that support chronic disease review and provide high-quality respiratory data 2. Willing to use advanced technology as part of clinical practice 3. At least 8 patients suitable for adherence technology 4. Actively prescribing Ultibro® Breezehaler® as a routine clinical care option; (i.e. inhaler compatible with the add-on technology) Patients suitable for adherence technology support: 1. Aged =40 years 2. Ever-smoker 3. On the COPD register of participating practices 4. Coded COPD diagnosis and FEV1/FVC ever recorded <0.7 5. At least 2 moderate/severe COPD exacerbations in the last 24 months (or prior to March 2020, if poorer) 6. Total adherence to current mono/dual therapy of =50% based on refill Rx data or a clinical EHR code for poor adherence in the last 12 months (or prior to March 2020, if poorer) Previous inclusion criteria: For a practice to be eligible for participation, the following criteria should be met: 1. Willing to receive OPC clinical audit and quality improvement services, including IT access for secure software installation and de-identified data extraction 2. Willing to use adherence technology as part of clinical practice 3. At least 16 patients suitable for adherence technology support (see below) 4. A clinician (doctor, nurse, pharmacist, etc) willing to act as a practice lead 5. Prescribing or able to prescribe Ultibro® Breezehaler® as a routine clinical care option i.e. inhaler compatible with the add-on technology Patients suitable for adherence technology support: 1. Confirmed COPD diagnosis 2. Smoking history 3. At least 2 COPD exacerbations in the last 24 months 4. Poor adherence to single/dual COPD therapy – Total adherence to current mono/dual therapy of =50% based on refill Rx data in the last 12 months
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 17/01/2025: Practice exclusion criteria: 1. Consent refusal code indicating opt-out of data used for research 2. Clinically unsuitable for LABA/LAMA therapy 3. Unresolved asthma diagnosis with an inhaled corticosteroid (ICS) prescription in the last 12 months 5. ASA arm only: Unable to use technology (e.g. not having/able to use a smartphone compatible with the technology, not having reliable Internet access) _____ Previous exclusion criteria as of 06/09/2023: Practice exclusion criteria: 1. General practice not prescribing Ultibro® as part of routine clinical care to patients with COPD 2. General practices hosting or affected by research, or other aspects of care, which might significantly influence the practice-wide implementation Patient exclusion criteria: 1. Patients with a consent refusal code indicating opt-out of data used for research 2. Patients not deemed clinically appropriate for the therapy which is technology-compatible 3. Patients on triple therapy (ICS/LABA/LAMA) 4. Read code for asthma (excluding ‘asthma resolved’ read codes) 5. Blood eosinophil count >300 cells/µl if blood count available in the last 12 months 6. Unable to use technology (e.g. not having/able to use a smartphone compatible with the technology, not having reliable Internet access) Previous exclusion criteria: GP Practice who cannot prescribe Ultibro breezhaler or currently do not prescribe Ultibro breezhaler
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 17/01/2025: The primary endpoint is time to treatment failure. Data will be collected from electronic medical health records. Time to treatment failure is defined as the time (in whole days) from baseline to the first occurrence of: 1. Moderate/severe COPD exacerbation, requiring: an acute oral corticosteroid course prescription, antibiotics prescribed with evidence of a lower respiratory consultation at the same day, respiratory-related hospital attendance/admission (based on GP medical record data), or respiratory-related A&E/ER attendance (based on GP medical record data) 2. Prescription of ICS 3. Prescription of additional chronic therapy for COPD (i.e. theophylline or other methylxanthines, maintenance oral corticosteroids, PDE4 inhibitors, macrolides (e.g. Azithromycin, Erythromycin), mucolytics (e.g. carbocysteine, N-acetylcysteine), or any other respiratory medication prescribed for COPD) 4. All-cause death _____ Previous primary outcome measure: The primary endpoint is time to treatment failure. Data will be collected from electronic medical health records. Time to treatment failure is defined as the time (in whole days) from baseline to the first occurrence of: 1. Moderate/severe COPD exacerbation, requiring: an acute oral corticosteroid course prescription, antibiotics prescribed with evidence of a lower respiratory consultation at the same day, respiratory-related hospital attendance/admission (based on GP medical record data), or respiratory-related A&E/ER attendance (based on GP medical record data) 2. Escalation of therapy to triple therapy (ICS/LABA/LAMA) 3. Prescription of additional chronic therapy for COPD (i.e. theophylline or other methylxanthines, maintenance oral corticosteroids, PDE4 inhibitors, macrolides (e.g. Azithromycin, Erythromycin), mucolytics (e.g. carbocysteine, N-acetylcysteine), or any other respiratory medication prescribed for COPD) 4. Respiratory-related death | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 17/01/2025: 1. Rate of moderate/severe exacerbations over the 12-month trial period (based on electronic medical record data) 2. Proportion of patients with at =1 moderate/severe exacerbation over the 12-month trial period (based on electronic medical record data) Exploratory outcome measures: 1. Adherence based on prescription refill records over 12 months 2. Respiratory-related healthcare resource utilization (HCRU) 3. Acceptance rate of the technological adherence support package at ASA sites _____ Previous secondary outcome measures: 1. Adherence, determined as Medication Possession Ratio (MPR) based on electronic medical record data at 12 months 2. Proportion of patients with moderate/severe exacerbations, and total number of exacerbations at 12 months, based on electronic medical record data, where exacerbation is defined as requiring: an acute oral corticosteroid course prescription, antibiotics prescribed with evidence of a lower respiratory consultation at the same day, respiratory-related hospital attendance or admission (based on GP medical record data), or respiratory-related A&E/ER attendance (based on GP medical record data) | — |
Countries
England, United Kingdom
Outcome results
None listed