Palliation of chronic breathlessness with morphine in patients with fibrotic interstitial lung disease – a randomised placebo-controlled trial

Kronborg-White, Sissel; Andersen, Charlotte Uggerhøj; Kohberg, Charlotte; Hilberg, Ole; Bendstrup, Elisabeth

doi:10.1186/s12931-020-01452-7

Cited by 23 publications

(33 citation statements)

References 27 publications

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“…Recently, Kronborg-White et al 22 found in a randomised controlled trial that oral morphine did not significantly reduce dyspnoea compared with placebo in patients with fibrotic ILD. Despite similarities between their trial and our study, there are some differences.…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

“… 20 21 A randomised controlled trial found that oral morphine did not significantly reduce dyspnoea compared with placebo in patients with fibrotic ILD. 22 To the best of our knowledge, no published prospective study other than the one mentioned above has examined the efficacy and safety of systemic morphine for dyspnoea in patients with ILD. 23–25 From the phase I study we conducted to investigate the safety of systemic morphine and determine the recommended dose of morphine to be used in further clinical trials, we reported that the recommended dose of single subcutaneous morphine for dyspnoea in patients with ILD is 2 mg. 26 The aim of this study is to estimate the efficacy of a single subcutaneous morphine injection for dyspnoea in patients with ILD.…”

Section: Introductionmentioning

confidence: 99%

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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)

Matsuda

Morita

Oyamada³

et al. 2021

BMJ Open

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IntroductionDyspnoea 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 analysisWe 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 disseminationEthical 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 numberjRCTs051190030; pre-results.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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)

Matsuda

Morita

Oyamada³

et al. 2021

BMJ Open

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“…As disease-specific HRQOL PROMs generally reflect changes in these parameters, these have characteristically been chosen for use in those clinical trials (77,98,100). As patient-centered research in ILD expands, future interventions may target the more disease-specific symptoms (e.g., cough, dyspnea, fatigue) (158)(159)(160). For these clinical trials, domain-specific PROMs focusing on each symptom may likely be chosen as the primary endpoint and therefore these instruments will need to be adapted for use cross-culturally.…”

Section: Remaining Gaps and Opportunitiesmentioning

confidence: 99%

Health Related Quality of Life in Interstitial Lung Disease: Can We Use the Same Concepts Around the World?

Aronson

Suzuki

2021

Front. Med.

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Health-Related Quality of Life (HRQOL) is increasingly viewed as an important patient-centered outcome by leading health organizations, clinicians, and patients alike. This is especially true in the interstitial lung disease community where patients often struggle with progressive and debilitating disease with few therapeutic options. In order to test the effectiveness of new pharmacologic therapies and non-pharmacologic interventions globally in ILD, this will require expansion of clinical research studies to a multinational level and HRQOL will be an important endpoint to many. In order to successfully expand trials across multiple nations and compare the results of studies between different communities we must recognize that there are differences in the concepts of HRQOL across the world and have strategies to address these differences. In this review, we will describe the different global influences on HRQOL both generally and in the context of ILD, discuss the processes of linguistic translation and cross-cultural adaptation of HRQOL Patient Reported Outcome Measures (PROMs), and highlight the gaps and opportunities for improving HRQOL measurement in ILD across the world.

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“…Breathing comfort is a high end-of-life priority for terminally ill patients [ 6 ], and the management of dyspnea is a serious unmet need in palliative care for ILD patients. Morphine and benzodiazepines are often administered to these patients in clinical practice to manage symptoms including dyspnea [ 7 , 8 ], but these medications were shown to be insufficiently effective for chronic breathlessness in a palliative care setting [ 9 ] and few reports have examined the effects of symptom relief in end-of-life settings.…”

Section: Introductionmentioning

confidence: 99%

Impact of end-of-life respiratory modalities on quality of dying and death and symptom relief in patients with interstitial lung disease: a multicenter descriptive cross-sectional study

et al. 2022

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Background Respiratory modalities applied at the end of life may affect the burden of distressing symptoms and quality of dying and death (QODD) among patients with end-stage interstitial lung disease (ILD); however, there have been few studies into respiratory modalities applied to these patients near death. We hypothesized that high-flow nasal cannula (HFNC) might contribute to improved QODD and symptom relief in patients with end-stage ILD. Objectives This multicenter study examined the proportion of end-of-life respiratory modalities in a hospital setting and explored its impact on QODD and symptom relief among patients dying with ILD. Methods Consecutive patients with ILD who died in four participating hospitals in Japan from 2015 to 2019 were identified and divided into four groups according to end-of-life respiratory modality: conventional oxygen therapy (COT), HFNC, non-invasive ventilation (NIV), and invasive mechanical ventilation (IMV). In addition, a mail survey was performed to quantify the QODD and symptom relief at their end of life from a bereaved family’s perspective. QODD and symptom relief were quantified using the Good Death Inventory (GDI) for patients with a completed bereavement survey. The impact of end-of-life respiratory modalities on QODD and symptom relief was measured by multivariable linear regression using COT as a reference. Results Among 177 patients analyzed for end-of-life respiratory modalities, 80 had a completed bereavement survey. The most common end-of-life respiratory modality was HFNC (n = 76, 42.9%), followed by COT (n = 62, 35.0%), NIV (n = 27, 15.3%), and IMV (n = 12, 6.8%). Regarding the place of death, 98.7% of patients treated with HFNC died outside the intensive care unit. Multivariable regression analyses revealed patients treated with HFNC had a higher GDI score for QODD [partial regression coefficient (B) = 0.46, 95% CI 0.07–0.86] and domain score related to symptom relief (B = 1.37, 95% CI 0.54–2.20) than those treated with COT. Conclusion HFNC was commonly used in patients with end-stage ILD who died in the hospital and was associated with higher bereaved family ratings of QODD and symptom relief. HFNC might contribute to improved QODD and symptom relief in these patients who die in a hospital setting.

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Palliation of chronic breathlessness with morphine in patients with fibrotic interstitial lung disease – a randomised placebo-controlled trial

Cited by 23 publications

References 27 publications

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)

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)

Health Related Quality of Life in Interstitial Lung Disease: Can We Use the Same Concepts Around the World?

Impact of end-of-life respiratory modalities on quality of dying and death and symptom relief in patients with interstitial lung disease: a multicenter descriptive cross-sectional study

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