NCT03701945: PRIME

Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD

Status unknown NA Last updated 8 July 2020

What this trial tests

NA trial testing Pulmonary rehabilitation in COPD Exacerbation in 156 participants. Status unknown.

Timeline

1 October 2018

Primary endpoint
30 June 2021

30 June 2021

Quick facts

Lead sponsor	Aveiro University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	156
Start date	1 October 2018
Primary completion	30 June 2021
Estimated completion	30 June 2021
Sites	1 location across Portugal

Drugs / interventions tested

• Pulmonary rehabilitation

Conditions studied

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

Sponsor

Aveiro University

Who can join

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

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Shared mechanisms of multimorbidity in COPD, atherosclerosis and type-2 diabetes: the neutrophil as a potential inflammatory target.
   Hughes MJ, McGettrick HM, Sapey E. · · 2020 · cited 41× · PMID 32198215 · DOI 10.1183/16000617.0102-2019
2. Monthly Follow-Ups of Functional Status in People with COPD: A Longitudinal Study.
   Rocha V, Cabral J, Souto-Miranda S, Machado AF, et al · · 2022 · cited 3× · PMID 35683440 · DOI 10.3390/jcm11113052