2023-503700-81-00招募中4 期
Palliation of Dyspnea and Cough using Morphine in patients with Fibrotic Interstitial Lung Disease
Aarhus University Hospital3 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年3月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 110
- 试验地点
- 3
- 主要终点
- The change in average VAS score for dyspnea the last 24-hours (baseline) measured over a week and after 4 weeks treatment with morphine.
研究概览
简要总结
The main object of the study is to examine the effect of 4 weeks treatment with slow-release morphine compared to placebo on the perception of breathlessness in patients with fibrotic interstitial lung diseases.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment period
- 盲法
- Double (Analyst, Investigator, Monitor, Subject, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •fibrotic interstitial lung disease
- •GAP (Gneder-Age-Physiology) score 2-3
- •Presence of fibroses on HRCT (tractionbronchiectasis, honeycombing, loss of volume >10% assessed by the investigator
- •MRC (Medical Research Councils) dyspnea score ≥ 3
- •Informed written consent
- •Age ≥ 18 år
- •Authoritative
排除标准
- •Regular treatment with morphine or morphine analogues
- •Allergy or intolerance to morphine or morphine analogues
- •Ongoing infection or exacerbation
- •Patients with so severe impaired respiration that any form of worsening would be too risky (assessed by the investigator)
- •Treatment with benzodiazepines (not benzodiazepine receptor agonists)
结局指标
主要结局
The change in average VAS score for dyspnea the last 24-hours (baseline) measured over a week and after 4 weeks treatment with morphine.
The change in average VAS score for dyspnea the last 24-hours (baseline) measured over a week and after 4 weeks treatment with morphine.
次要结局
- Change in walking distance during 6-minute walk test from baseline to follow-up after 4 weeks of treatment
- Change in level of desaturation at 6-minute walk test from baseline to follow-up after 4 weeks of treatment
- Change in BORG dyspnea scale at 6-minute walk test from baseline to follow-up after 4 weeks of treatment
- Change in questionnaire (VAS for tough, Leicester Cough Questionnaire, King's Brief Lung Disease Questionnaire, COPD assessment Score) from baseline to follow-up after 4 weeks of treatment
研究者
Sissel Kronborg-White
Scientific
Aarhus University Hospital
研究点 (3)
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