EUCTR2019-003571-19-GB进行中（未招募）1 期
PAciFy Cough: A multicentre, double blind, placebo controlled, crossover trial of morphine sulfate for the treatment of PulmonAry Fibrosis Cough - PACIFY Cough
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Self-reported cough (> 8 weeks) with cough VAS = 30/100
- •2.A diagnosis of IPF within 5 years prior to the screening visit, as per applicable ATS/ERS/JRS/ALAT guidelines, in line with hospital records
- •3.1Male and female participants aged = 40 – 90 years at the time of signing informed consent
- •4.1 Male participants: A male participant must agree to use contraception as detailed in Appendix 2 of this protocol during the study and for at least 90 days after the follow-up visit, and refrain from donating sperm during this period
- •4.2 Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP) as defined in Appendix 2.
- •5.Meeting all of the following criteria during the screening period: FVC = 45% predicted of normal, Forced expiratory volume in 1 second (FEV1)/FVC =0.7, DLCO corrected for Hb =30% predicted of normal.
- •6.The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (investigator determined within 24 months of the study screening visit).
- •7.Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •?1.Treatment with immunosuppressive therapy or antibiotics within last 4 weeks of screening visit. A stable dose of corticosteroids equivalent to prednisolone of 10 mg per day or less, if used for an indication other than pulmonary disease will be permitted.
- •2.Current smoker
- •3.History of alcohol and drug(s) addiction
- •4.Regular use of sedative therapies
- •5.Acute IPF exacerbation within 6 months prior to screening and/or during the screening period.
- •6.Concurrent use of pirfenidone or Nintedanib, unless receiving a stable dose for at least 8 weeks prior to screening
- •7.Use of ACE inhibitors
- •8.Patients with co-existent conditions known to be associated with the development of fibrotic lung disease. This includes; connective tissue disease, suspected drug-induced lung disease, asbestosis or other asbestos related disease (pleural plaques, mesothelioma), granulomatous disease including sarcoidosis. Patients with an auto-immune profile considered diagnostic for a specific connective tissue disease will be excluded, even in the absence of systemic symptoms. Non-specific rises in auto antibodies e.g. rheumatoid factor, anti-nuclear antibody etc. will not be used to exclude individuals from the study.
- •9.Significant other organ co-morbidity including hepatic or renal impairment and pulmonary hypertension (investigator determined).
- •10.Significant coronary artery disease (myocardial infarction within 6 months or ongoing unstable angina within 4 weeks of screening visit) or congestive cardiac failure based on clinical examination
- •11.Patients at significant risk for side effects, intolerance or allergy to morphine
- •12.Pregnant and breastfeeding patients, or women of child-bearing potential, not using a reliable contraceptive method (see Appendix 2). A urine pregnancy test will be performed in females of child-bearing potential at the initial study visit.
- •13.Unable to provide informed written consent
- •14.Predicted life expectancy < 6 months
- •15.Use of long-term oxygen therapy. Use of ambulatory oxygen will be permitted.
- •16.Current or use of opiates within 14 days of the screening visit.
研究者
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