A pilot study of the use of oral modafinil added to standard care in hypercapnic respiratory failure in COPD - modafinil in hypercapnic respiratory failure

Epsom and St Helier University Hospitals NHS Trust R&D Dpt0 个研究点目标入组 60 人开始时间: 2014年8月28日最近更新: 2015年2月16日

适应症

试验速览

暂无简介。

•i.Male or female.
•ii.Aged 40 – 86 years
•iii.An established clinical history consistent with COPD and known chronic hypercapnic respiratory failure on standard treatments.
•iv.Arterial gases confirming known hypercapnia with PaO2 below 8.1kPa and arterial carbon dioxide level >7.5 kPa in the absence of an exacerbation.
•v.No use of oxygen or nasal ventilator nor CPAP machine
•vi.Able to comply with questionnaires and assessments
•vii.No history of significant renal or liver failure or uncontrolled hypertension that would preclude the use of modafinil.
•viii.No history of significant psychological disturbances
•ix.No drugs that are likely to interact with modafinil
•x.No evidence of current left cardiac failure.
•xi.Compliant with all standard COPD treatments including inhalers, nebulizers and theophyllines and steroids to optimize COPD care.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•1. On NIPPV or CPAP
•2. Adverse reaction to modafinil
•3. Likely interaction of other drugs with modafinil
•4. Psychiatric illness/anxiety that maybe adversely affected my modafinil
•5. Hypercapnic respiratory failure only during an acute COPD exacerbation.
•6.A recognized coexisting respiratory disorder that in the opinion of the investigator would put the patient at risk or invalidate the study outcome measures.
•7.Epilepsy, significant psychological disorders, un-controlled hypertension, known significant liver or kidney disease.

发起方

Epsom and St Helier University Hospitals NHS Trust R&D Dpt