Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD — PRIME  

COPD Clinical Trial

Official title: Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD

Status Recruiting

Clinical Trial Summary

PRIME goal is to early detect and treat acute exacerbations of chronic obstructive pulmonary disease (AECOPD). This is important since COPD accelerates aging and represents major burden worldwide and in Portugal, mainly due to its frequent AECOPD. Pulmonary rehabilitation (PR) is an effective strategy of its management but it is scarce. When AECOPD are early detected and treated, it optimizes patients' outcomes and reduces the burden of COPD, especially if PR is used. However, up to date, there is no model to predict AECOPD for clinical practice. The lung microbiota shows promise to overcome this barrier and inform on COPD trajectory and will be investigated. In addition, despite of most AECOPD being managed in the community, PR is mainly available in hospitals and less than 1% of patients are having access. Thus, community-based PR will be implemented and a clinical decision tool developed for prioritizing who will most benefit from PR, enhancing evidence-based access to PR.

Clinical Trial Description

PRIME aims to address these two gaps, establishing the role of microbiota and clinical data in predicting AECOPD and increasing the evidence on PR in AECOPD through the translation of PR guidelines to the community. Specifically, it aims to:

• Explore the longitudinal changes in microbiota and clinical data between stable and exacerbations periods;

• Establish the feasibility and short- and long-term effects of community-based PR for AECOPD;

• Define the characteristics of patients who most benefit from community-based PR.

156 patients with COPD will be followed monthly for a year and their lung microbiota and clinical data will be analysed. Community-based PR will be delivered to 56 patients. Data will be collected before, at 3 weeks, after PR and at 6 months to assess the feasibility and effects of PR. A clinical decision-making tool (CDMT) to prioritise patients with AECOPD for PR will be developed.

The experienced multidisciplinary team will ensure the following novel results:

• a clinical and lung microbiota profile of patients with COPD;

• a model of AECOPD prediction;

• recommendations for community-based PR in AECOPD;

• a CDMT to prioritise patients with AECOPD for PR.

PRIME will contribute to optimise outcomes, improve AECOPD healthcare services and reduce the burden with COPD. ;

Related Conditions & MeSH terms

• COPD
• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

• NCT number: NCT03701945
• Study type: Interventional
• Source: Aveiro University
• Contact: Alda Marques, PhD
• Phone: 00351 234 372 462
• Email: amarques@ua.pt
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2018
• Completion date: June 30, 2021