Chronic Obstructive Pulmonary Disease Respiratory
Conditions
Interventions
Design: The study is a 16-week (112 day) randomised controlled trial (RCT) which will be operated over four centres.
An RCT is a rigorously monitored study which attempts, as far as is possible, to re
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Sponsors
Hull University Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Age
30 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged > = 30 years 2. Clinician diagnosed COPD with airflow obstruction, confirmed on spirometry (FEV-1/FVC ratio = 10 pack-year smoking history 4. Modified Medical Research Council Dyspnoea Scale (mMRC) breathlessness score > = 2 5. Patients receiving optimal guideline recommended inhaled treatment for COPD, including a minimum of dual-acting bronchodilator therapy (long-acting beta-agonist and long-acting muscarinic antagonist) with or without an inhaled corticosteroid. 6. Patients prescribed > = 12 SABA inhalers/canisters within the past year with self-reported SABA use most days. Only those prescribed a pressurised metered dose inhaler (pMDI) SABA are eligible for inclusion. 7. Provision of written informed consent 8. Willing and able to comply with all required study activities
Exclusion criteria
Exclusion criteria: 1. Those with significant cardiorespiratory disease, other than COPD, considered the primary cause of their breathlessness/high SABA use. 2. Those with a COPD exacerbation requiring oral corticosteroids and/or antibiotics and/or hospitalisation within 4-weeks before recruitment (taken from last day of exacerbation treatment). 3. Those with a planned pulmonary rehabilitation attendance during the study (pulmonary rehabilitation referral will be offered one on completing trial participation if appropriate).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean daily SABA use from baseline (days -28-0) at days 56 - 84. Daily SABA use will be recorded throughout the trial | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. COPD Assessment Test (CAT) score at Day -28, 0, 28, 56, and 84 2. Breathlessness numerical rating scales for ‘worst’, ‘distress caused by’ and ‘coping with’ breathlessness within the past 24 hours at Day -28, 0, 28, 56, and 84 3. Modelled annual SABA inhaler/cannister pick-up rate will be reported (based on number of actuations at baseline (days -28 – 0) and between days 56 and 84 4. Health-related quality-of-life: EQ-5D-5L and VAS at Day -28, 0 and 84 5. Healthcare-resource-utilisation measured using self-reported usage and medical records at Day 0, 28, 56 and 84 6. Modelled CO2e (for COPD treatments alone and combined for COPD treatments, study intervention and healthcare-resource-utilisation) using calculated carbon footprint of fan, calculated carbon footprint of inhalers, as well as calculated carbon footprint of healthcare utilisation while in the study at Day -28 – Day 84 Feasibility outcome measures: 1. Recruitment and retention: recruitment rate (per site and aggregated), eligibility to consent ratio, screen failures and participant retention measured using completed consent forms, screening and enrolment logs, and number of participants completing the study at Day -28 and end of study 2. Data quality and integrity: Amount and pattern of missing data (SABA inhaler use) measured through sensor recorded data collected perpetually throughout participant duration e.g., Day -28 – Day 112 3. Intervention: feasibility, acceptability and fidelity of the intervention will be measured through adherence in delivery and uptake of the intervention (as a whole and individual intervention components) as documented in the eCRF. Overall intervention acceptability will be assessed via qualitative interviews conducted at the end of participants participation in the RCT e.g., post-Day 112. For those participants that withdrew from the study, interviews may be held at any time post-withdrawal. | — |
Countries
England, United Kingdom
Outcome results
None listed