Randomized phase 2 study of the efficacy of morphine for dyspnea in patients with interstitial lung disease

• Project/Area Number: 17K15909
• Research Category: Grant-in-Aid for Young Scientists (B)
• Allocation Type: Multi-year Fund
• Research Field: General internal medicine(including psychosomatic medicine)
• Research Institution: NHO Kinki Chuo Chest Medical Center(Clinical Research Center)
• Principal Investigator: Matsuda Yoshinobu 独立行政法人国立病院機構近畿中央呼吸器センター, 心療内科, 心療内科医長 (40505666)
• Project Period (FY): 2017-04-01 – 2023-03-31
• Project Status: Completed (Fiscal Year 2022)
• Budget Amount: ¥4,030,000 (Direct Cost: ¥3,100,000、Indirect Cost: ¥930,000); Fiscal Year 2020: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000); Fiscal Year 2019: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000); Fiscal Year 2018: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000); Fiscal Year 2017: ¥1,430,000 (Direct Cost: ¥1,100,000、Indirect Cost: ¥330,000)
• Keywords: 間質性肺疾患 / 呼吸困難 / モルヒネ / 緩和ケア / 多施設共同研究 / 認定IRB / EDC / 多施設共同試験 / 研究計画書 / 研究支援組織

Outline of Final Research Achievements

Patient enrollment began on June 13, 2019 and 36/50 patients were enrolled as of March 31, 2023.The study was presented at the Joint Meeting of Palliative, Supportive and Psycho-Oncology Care in August 2020 and was selected as the outstanding presentation. In addition, the protocol of this study was published in 2021 in BMJ Opne.

Academic Significance and Societal Importance of the Research Achievements

現時点では、目標登録数である50例に到達していないが、本試験が完遂し、間質性肺疾患の呼吸困難に対するモルヒネの有効性が示されれば、モルヒネ注射剤の臨床試験としては初の結果であり、学術的意義が大きい。また、本研究の出口戦略である、①緩和ケア教育モジュールへの反映、②診療ガイドラインへの収載、③社会保険診療報酬支払い基金への検討依頼を通じて間質性肺疾患の呼吸困難に対するモルヒネの使用が標準治療になれば、多くの呼吸困難患者のQOL向上に役立つ。

Research Products

• [Journal Article] 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) (2021)
  • Author(s): Matsuda Yoshinobu、Morita Tatsuya、Oyamada Shunsuke、Ariyoshi Keisuke、Yamaguchi Takuhiro、Iwase Satoru
  • Journal Title: BMJ Open Volume: 11 Issue: 5 Pages: e043156-e043156
  • DOI: 10.1136/bmjopen-2020-043156
  • Peer Reviewed / Open Access
• [Journal Article] Morphine for Refractory Dyspnea in Interstitial Lung Disease: A Phase I Study (JORTC-PAL 05) (2018)
  • Author(s): Matsuda Yoshinobu、Morita Tatsuya、Miyaji Tempei、Ogawa Tomoko、Kato Kuniko、Kawaguchi Takashi、Tokoro Akihiro、Iwase Satoru、Yamaguchi Takuhiro、Inoue Yoshikazu
  • Journal Title: Journal of Palliative Medicine Volume: 21 Issue: 12 Pages: 1718-1723
  • DOI: 10.1089/jpm.2018.0272
  • Peer Reviewed
• [Journal Article] Low-Dose Morphine for Dyspnea in Terminally Ill Patients with Idiopathic Interstitial Pneumonias (2017)
  • Author(s): Matsuda Yoshinobu、Maeda Isseki、Tachibana Kazunobu、Nakao Keiko、Sasaki Yumiko、Sugimoto Chikatoshi、Arai Toru、Tokoro Akihiro、Akira Masanori、Inoue Yoshikazu
  • Journal Title: Journal of Palliative Medicine Volume: 20 Issue: 8 Pages: 879-883
  • DOI: 10.1089/jpm.2016.0432
  • Peer Reviewed
• [Presentation] 間質性肺疾患の呼吸困難に対するモルヒネ (2018)
  • Author(s): 松田能宣
  • Organizer: 第23回日本緩和医療学会学術大会
• [Presentation] 間質性肺疾患の呼吸困難に対するモルヒネの安全性に関する第I相試験: JORTC-PAL05 (2017)
  • Author(s): 松田能宣
  • Organizer: 第22回日本緩和医療学会学術大会
• [Presentation] Phase I study of safety of morphine for dyspnea in patients with interstitial lung diseases: JORTC PAL05 study (2017)
  • Author(s): Yoshinobu Matsuda
  • Organizer: American Thoracic Society International Conference 2017