Title {1} | PAciFy Cough – A multicentre, double blind, placebo controlled, crossover trial of morphine sulfate for the treatment of PulmonAry Fibrosis Cough |
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Trial registration {2a and 2b}. | EudraCT number: 2019-003571-19 |
Protocol version {3} | 8th March 2021, version 4.1 |
Funding {4} | This study is fully funded by the Moulton Charitable Foundation. |
Author details {5a} |
Zhe Wu – Royal Brompton Hospital, Guy’s and St Thomas’ NHS Foundation Trust; National Heart and Lung Institute, Imperial College London Winston Banya – Royal Brompton Hospital, Guy’s and St Thomas’ NHS Foundation Trust Nazia Chaudhuri – Manchester University NHS Foundation Trust Ira Jakupovic – Royal Brompton and Harefield Hospitals, Guy’s and St Thomas’ NHS Foundation Trust Toby M Maher – Keck School of Medicine, University of Southern California Brijesh Patel – Royal Brompton Hospital, Guy’s and St Thomas’ NHS Foundation Trust Lisa Spencer – Liverpool Interstitial Lung Disease Service, Aintree University Hospital, Liverpool University Hospitals NHS Foundation Trust Muhunthan Thillai – Royal Papworth Hospital; Department of Medicine, University of Cambridge Alex West – Guy’s and St Thomas’ NHS Foundation Trust John Westoby – lay member Marlies Wijsenbeek – Centre for Interstitial Lung Disease and Sarcoidosis, Erasmus University Medical Centre Rotterdam Jaclyn Smith - Division of Infection, Immunity and Respiratory Medicine, Manchester Academic Health Science Centre, University of Manchester Philip L Molyneaux - National Heart and Lung Institute, Imperial College London & Royal Brompton Hospital, Guy’s and St Thomas’ NHS Foundation Trust |
Name and contact information for the trial sponsor {5b} |
Royal Brompton and Harefield Hospitals (RBHH) Ira Jakupovic, Research Governance and Regulatory Compliance Manager Guy’s and St Thomas’ NHS Foundation Trust (GSTFT) Royal Brompton and Harefield Hospitals (RBHH) Research Office, Chelsea Wing, Level 2, Sydney Street, London, SW3 6NP |
Role of sponsor {5c} |
The study sponsor has overseen the design of the study and will have oversight of the trial. The sponsor has ensured that the trial protocol, Patient Information Sheet (PIS), Informed Consent Form (ICF), GP letter and submitted supporting documents have been approved by the MHRA and a main Research Ethics Committee (REC), prior to any patient recruitment taking place. This study will be conducted in compliance with the protocol approved by the REC and according to GCP standards and UK Clinical Trials Regulation. Data ownership rights will lie with the institution. Our expectation is that after data analysis, information from this study will be widely disseminated in the medical and scientific community. |