Palliation of Dyspnea With Morphine in Patients With Interstitial Lung Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- VAS dyspnea score
研究概览
简要总结
36 patients with interstitial lung disease will be randomized to 1 weeks treatment with morphine hydrochloride as oral linctus 5 mg, four times a day, and 5 mg as needed up to 4 times a day, or corresponding doses of placebo.
VAS score for dyspnea will be evaluated after 1 hour and 1 week at follow up. Other questionnaires will also be evaluated (GAD-7, K-BUILD, Leicester score)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of interstitial lung disease (IPF, NSIP, RA-ILS, Scl-ILS, MCTD-ILS, asbestous, drug induced ILD, unclassified ILD)
- •Dyspnea corresponding to Medial Research Councils (MRC) dyspnea score ≥ 3
- •Written consent
- •Age ≥ 18 years
- •Competent
- •For fertile women: Negative pregnancy test
- •For fertile and sexually active participants: Use of safe anti-conceptionals
排除标准
- •Ongoing infection
- •Decreased lung function to a degree which makes any form of respiratory depression life threatening
- •Treatment with morphine or morphine analogues
- •Allergy towards morphine hydrochloride
研究组 & 干预措施
Morphine
18 patients treated with oral morphine hydrochloride linctus 5 mg 4 four times daily and as needed up to 4 times daily
干预措施: Morphine hydrochloride (Drug)
Placebo
18 patients treated with oral linctus corresponding to 5 mg morphine hydrochloride, four times daily and as needed up to 4 times daily
干预措施: Placebo (Other)
结局指标
主要结局
VAS dyspnea score
时间窗: 1 week
次要结局
- Oxygen saturation(1 hour and 1 week)
- K-bild questionnaire(1 week)
- GAD-7 questionnaire(1 week)
- 6 min walk test(1 hour and 1 week)
- Leicester Score(1 week)
研究者
Charlotte Andersen
MD, PhD
University of Aarhus