06/01/2018 **The study has been successfully enrolled. Screening is now closed.**
A Clinical Trial for Individuals with PCD
Parion Sciences and Vertex Pharmaceuticals announce the CLEAN-PCD trial of a novel inhaled compound (VX-371) designed to improve airway hydration and aid with clearance of mucus. CLEAN-PCD, an international clinical study, will evaluate the effectiveness of this compound in individuals with PCD. For more information about this particular study, please visit the official Clinical Trials Site.
Rationale
In PCD, ineffective ciliary function leads to stagnant mucus in the airways. Retained mucus is a breeding ground for infectious pathogens. Infection and inflammation in the airways triggers additional mucus production and the mucus becomes thicker and harder to remove. This creates a ‘vicious cycle’ of mucus hypersecrection, infection, inflammation and more mucus hypersecretion. The proposed mechanism of this investigational compound VX-371 is reducing the burden of this vicious cycle through more effective clearance of mucus.
Criteria
To preserve the integrity of the data collected during the CLEAN-PCD trial, there are carefully selected inclusion (who can participate) and exclusion (who cannot) criteria for this study. Clinical studies seek to answer a clinical question(s) and to ensure that these questions are the only focus, careful attention is paid to prevent ‘confounding’ issues from arising. Inclusion and exclusion criteria for CLEAN-PCD can be found at the link below.
Please note that there are 35 centers in 8 countries participating in this trial so far and individuals who wish to participate will need to be seen at one of these centers.
Study Design
The study design for CLEAN-PCD ensures that every participant will be on the investigational drug at some point during the trial. There will be two phases–one on drug or placebo, followed by a washout period, and then the second phase where participants will receive either the drug or placebo they did not get in phase I.
Goal
The goal of research is to provide generalized knowledge that can be applied to a population under study. This is different than a therapeutic relationship with your own doctor, which is designed to help you as an individual. You may not personally benefit from participating in research. Choosing not to participate in a clinical trial will not affect your relationship with your healthcare provider or with the PCDF. It is a strictly personal decision.
*Study Update*
06/01/2018 The study has been successfully enrolled. Screening is now closed.
DISCLAIMER: Information about the CLEAN-PCD study is provided for information only and does not constitute an endorsement by the PCDF.
