Cargando…
Study protocol for a randomised, placebo-controlled, single-blind phase II study of the efficacy of morphine for dyspnoea in patients with interstitial lung disease (JORTC-PAL 15)
INTRODUCTION: Dyspnoea is common in patients with interstitial lung disease (ILD) and often refractory to conventional treatment. Little is known about the efficacy of systemic morphine for dyspnoea in patients with ILD. The aim of this study is to estimate the efficacy of a single subcutaneous morp...
Autores principales: | , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2021
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8130746/ https://www.ncbi.nlm.nih.gov/pubmed/34006542 http://dx.doi.org/10.1136/bmjopen-2020-043156 |
_version_ | 1783694585597263872 |
---|---|
author | Matsuda, Yoshinobu Morita, Tatsuya Oyamada, Shunsuke Ariyoshi, Keisuke Yamaguchi, Takuhiro Iwase, Satoru |
author_facet | Matsuda, Yoshinobu Morita, Tatsuya Oyamada, Shunsuke Ariyoshi, Keisuke Yamaguchi, Takuhiro Iwase, Satoru |
author_sort | Matsuda, Yoshinobu |
collection | PubMed |
description | INTRODUCTION: Dyspnoea is common in patients with interstitial lung disease (ILD) and often refractory to conventional treatment. Little is known about the efficacy of systemic morphine for dyspnoea in patients with ILD. The aim of this study is to estimate the efficacy of a single subcutaneous morphine injection for dyspnoea in patients with ILD. METHODS AND ANALYSIS: We will conduct a multicentre, prospective, randomised, placebo-controlled, single-blinded phase II study of a single subcutaneous morphine injection for dyspnoea in patients with ILD. In patients with ILD who have dyspnoea at rest refractory to conventional treatment will be eligible for participation in this study. The morphine dose will be 2 mg. The primary endpoint is changes in dyspnoea intensity from baseline to 60 min after treatment as measured using an 11-point Numerical Rating Scale and compared between the morphine and placebo groups. ETHICS AND DISSEMINATION: Ethical approval has been obtained by the Osaka City University Certified Review Board. The results of this study will be submitted for publication in an international peer-reviewed journal and the findings will be presented at international scientific conferences. TRIAL REGISTRATION NUMBER: jRCTs051190030; pre-results. |
format | Online Article Text |
id | pubmed-8130746 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-81307462021-05-27 Study protocol for a randomised, placebo-controlled, single-blind phase II study of the efficacy of morphine for dyspnoea in patients with interstitial lung disease (JORTC-PAL 15) Matsuda, Yoshinobu Morita, Tatsuya Oyamada, Shunsuke Ariyoshi, Keisuke Yamaguchi, Takuhiro Iwase, Satoru BMJ Open Respiratory Medicine INTRODUCTION: Dyspnoea is common in patients with interstitial lung disease (ILD) and often refractory to conventional treatment. Little is known about the efficacy of systemic morphine for dyspnoea in patients with ILD. The aim of this study is to estimate the efficacy of a single subcutaneous morphine injection for dyspnoea in patients with ILD. METHODS AND ANALYSIS: We will conduct a multicentre, prospective, randomised, placebo-controlled, single-blinded phase II study of a single subcutaneous morphine injection for dyspnoea in patients with ILD. In patients with ILD who have dyspnoea at rest refractory to conventional treatment will be eligible for participation in this study. The morphine dose will be 2 mg. The primary endpoint is changes in dyspnoea intensity from baseline to 60 min after treatment as measured using an 11-point Numerical Rating Scale and compared between the morphine and placebo groups. ETHICS AND DISSEMINATION: Ethical approval has been obtained by the Osaka City University Certified Review Board. The results of this study will be submitted for publication in an international peer-reviewed journal and the findings will be presented at international scientific conferences. TRIAL REGISTRATION NUMBER: jRCTs051190030; pre-results. BMJ Publishing Group 2021-05-18 /pmc/articles/PMC8130746/ /pubmed/34006542 http://dx.doi.org/10.1136/bmjopen-2020-043156 Text en © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Respiratory Medicine Matsuda, Yoshinobu Morita, Tatsuya Oyamada, Shunsuke Ariyoshi, Keisuke Yamaguchi, Takuhiro Iwase, Satoru Study protocol for a randomised, placebo-controlled, single-blind phase II study of the efficacy of morphine for dyspnoea in patients with interstitial lung disease (JORTC-PAL 15) |
title | Study protocol for a randomised, placebo-controlled, single-blind phase II study of the efficacy of morphine for dyspnoea in patients with interstitial lung disease (JORTC-PAL 15) |
title_full | Study protocol for a randomised, placebo-controlled, single-blind phase II study of the efficacy of morphine for dyspnoea in patients with interstitial lung disease (JORTC-PAL 15) |
title_fullStr | Study protocol for a randomised, placebo-controlled, single-blind phase II study of the efficacy of morphine for dyspnoea in patients with interstitial lung disease (JORTC-PAL 15) |
title_full_unstemmed | Study protocol for a randomised, placebo-controlled, single-blind phase II study of the efficacy of morphine for dyspnoea in patients with interstitial lung disease (JORTC-PAL 15) |
title_short | Study protocol for a randomised, placebo-controlled, single-blind phase II study of the efficacy of morphine for dyspnoea in patients with interstitial lung disease (JORTC-PAL 15) |
title_sort | study protocol for a randomised, placebo-controlled, single-blind phase ii study of the efficacy of morphine for dyspnoea in patients with interstitial lung disease (jortc-pal 15) |
topic | Respiratory Medicine |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8130746/ https://www.ncbi.nlm.nih.gov/pubmed/34006542 http://dx.doi.org/10.1136/bmjopen-2020-043156 |
work_keys_str_mv | AT matsudayoshinobu studyprotocolforarandomisedplacebocontrolledsingleblindphaseiistudyoftheefficacyofmorphinefordyspnoeainpatientswithinterstitiallungdiseasejortcpal15 AT moritatatsuya studyprotocolforarandomisedplacebocontrolledsingleblindphaseiistudyoftheefficacyofmorphinefordyspnoeainpatientswithinterstitiallungdiseasejortcpal15 AT oyamadashunsuke studyprotocolforarandomisedplacebocontrolledsingleblindphaseiistudyoftheefficacyofmorphinefordyspnoeainpatientswithinterstitiallungdiseasejortcpal15 AT ariyoshikeisuke studyprotocolforarandomisedplacebocontrolledsingleblindphaseiistudyoftheefficacyofmorphinefordyspnoeainpatientswithinterstitiallungdiseasejortcpal15 AT yamaguchitakuhiro studyprotocolforarandomisedplacebocontrolledsingleblindphaseiistudyoftheefficacyofmorphinefordyspnoeainpatientswithinterstitiallungdiseasejortcpal15 AT iwasesatoru studyprotocolforarandomisedplacebocontrolledsingleblindphaseiistudyoftheefficacyofmorphinefordyspnoeainpatientswithinterstitiallungdiseasejortcpal15 |