NCT06347536: RAPID

Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

Recruiting now Phase 3 Last updated 10 February 2025

What this trial tests

Phase 3 trial testing Supported rescue pack in COPD in 1,400 participants. Currently enrolling.

Timeline

30 January 2025

Primary endpoint
31 December 2027

31 December 2027

Quick facts

Lead sponsor	Guy's and St Thomas' NHS Foundation Trust
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	1,400
Start date	30 January 2025
Primary completion	31 December 2027
Estimated completion	31 December 2027
Sites	34 locations across United Kingdom

Drugs / interventions tested

• Supported rescue pack

Conditions studied

• COPD — all drugs for COPD →
• COPD Exacerbation — all drugs for COPD Exacerbation →

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Who can join

40 and older, any sex, with COPD or COPD Exacerbation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Chronic obstructive pulmonary disease (COPD) is a chronic lung disease affecting approximately 10% of the adult population globally. COPD is recognised to be an important area of focus, as part of one of the healthcare challenges defined by the Office of Life Sciences. Patients with COPD often experience exacerbations which are triggered episodes leading to disease worsening. Exacerbations are associated with increased morbidity and a risk of mortality.

Severe exacerbations, where patients are hospitalised, are of particular concern to patients, carers and healthcare givers. The National Institute for Health and Care Excellence (NICE) recommends that hospital clinicians looking after patients with COPD should provide rescue packs (a course of prednisolone and antibiotics) and a basic management plan to patients on discharge. It is recognised that there is a high-risk 90-day period to patients with COPD following discharge from hospital, where there is a 43% risk of readmission and a 12% risk of mortality; however repeated national audit data has shown that, despite NICE recommendations this high risk of readmission and mortality has not changed.

A multicentre randomised clinical trial of 1400 patients will be conducted in 30 acute NHS trusts. This will test the hypothesis that a self-supported rescue pack management plan consisting of rescue packs + written self-management plan + twice weekly telephone/text symptom alert assessments in the high-risk 90-day period is better than standard care in reducing 90-day readmission by 20%. If successful, this intervention would be rapidly implementable, improve patient clinical outcomes and have a cost saving of approximately £350 million per annum.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.