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  • 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)

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Respiratory medicine
Protocol
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)
  1. Yoshinobu Matsuda1,
  2. Tatsuya Morita2,
  3. Shunsuke Oyamada3,
  4. Keisuke Ariyoshi4,
  5. Takuhiro Yamaguchi5,
  6. Satoru Iwase6
  1. 1Department of Psychosomatic Internal Medicine, National Hospital Organisation Kinki-Chuo Chest Medical Center, Sakai, Japan
  2. 2Palliative and Supportive Care Division, Seirei Mikatahara Hospital, Hamamatsu, Japan
  3. 3Department of Biostatictics, JORTC Data Center, Tokyo, Japan
  4. 4Department of Data Management, JORTC Data Center, Tokyo, Japan
  5. 5Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan
  6. 6Department of Palliative Medicine, Saitama Medical University, Moroyama, Japan
  1. Correspondence to Dr Yoshinobu Matsuda; matsuda.yoshinobu.tx{at}mail.hosp.go.jp

Abstract

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.

  • interstitial lung disease
  • palliative care
  • clinical trials
http://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://doi.org/10.1136/bmjopen-2020-043156

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    Footnotes

    • Contributors YM: lead author of the study protocol and principal investigator. YM, TM, SO, KA, TY and SI: participated in the design of the study. SO and TY: designed the statistical analysis plan. All authors contributed to writing and revising the manuscript critically, and all gave their final approval of the version to be published.

    • Funding This study was supported by the following grants: 2018–2020 Grant-in-Aid for Scientific Research (Grant-in-Aid for Young Scientists B; grant number 17K15909) and Osaka Medical Research Foundation for Intractable Diseases (grant number 23-2-41).

    • Disclaimer The funders had no role in the study design and will have no role in the data collection, analysis or dissemination of study results.

    • Competing interests None declared.

    • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

    • Provenance and peer review Not commissioned; externally peer reviewed.