NCT04497831Unknown3 期
Determining the Effectiveness of Nebulized Morphine in Treating Dyspnea in Advanced Idiopathic Pulmonary Fibrosis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 入组人数
- 20
- 主要终点
- The primary end point is a reduction of breathlessness intensity by ≥20 mm at 100 mm visual analogue scale (VAS) after nebulization, during daily, normal activities
研究概览
简要总结
"Determination of the effectiveness of nebulized morphine in the treatment of dyspnea in patients with advanced idiopathic pulmonary fibrosis"
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IPF diagnosis in accordance with guidelines
- •Period of stable disease
- •Dyspnea rated 3 to 4 in mMRC scale
- •Current non-smoker
- •Other potential causes of breathlessness such as kidney or heart failure optimally treated in the opinion of the principal investigator
- •Able to complete questionnaires and trial assessments
- •Ability to give informed consent
- •If female, must be:
- •postmenopausal (no menses for 12 months without an alternative medical cause)
- •using acceptable contraception and agree to exclude pregnancy with pregnancy test in the beginning of the hospitalization
排除标准
- •- other coexisting severe chronic lung diseases
- •absolute contraindications to six-minute-walking-test according to
- •Polish Respiratory Society guidelines:
- •< 7-10 days since coronary interventions due to STEMI
- •< 24 h since planned coronary intervention
- •myocarditis/pericarditis
- •symptomatic rhythm and conduction abnormalities
- •acute deep vein thrombosis, pulmonary embolism, pulmonary infarction
- •decompensated heart failure
- •acute infection and other diseases which can significantly impact the test result (eg. severe anemia, acute kidney or liver failure, hypo- or hyperthyroidism, etc)
- •contraindications to morphine hydrochloride:
- •previous history of respiratory depression after opioid administration
- •previous history of allergic reactions to opioids
- •severe ventilation impairment due to e.g. asthmatic state, airway foreign body
- •severe kidney or liver failure
- •increased intracranial pressure
- •head injury
- •cerebral edema
- •seizure disorders
- •acute alcohol poisoning
- •acute abdomen
- •acute diarrhea caused by infection or food poisoning;
- •patients at risk of paralytic ileus;
- •biliary colic;
- •phaeochromocytoma;
- •simultaneous MAO inhibitor treatment and immediate 2-week period following its discontinuation - ongoing opioid treatment for any indication
研究组 & 干预措施
Study Drug
Experimental
Morphine hydrochloride
干预措施: Morphine hydrochloride (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The primary end point is a reduction of breathlessness intensity by ≥20 mm at 100 mm visual analogue scale (VAS) after nebulization, during daily, normal activities
时间窗: Breathlessness during daily, normal activities will be measured with VAS 1 hour before nebulization and 4 hours after
The primary end point is a reduction of breathlessness intensity by ≥20 mm at 100 mm visual analogue scale (VAS) after nebulization, during daily, normal activities
次要结局
- Secondary end point(Cough and chest pain severity during normal activities will be assessed with VAS 1h before nebulization and 4 hours after Six minute walking test, along with breathlessness, cough and chest pain assessment in VAS, will be performed 1h before nebuli)
研究者
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