ISRCTN15705669Terminated未知
A study to assess the benefit of modafinil in COPD with type-2 respiratory failure: an open randomised study
St Helier Hospital, R&D Dept0 sites40 target enrollmentStarted: November 11, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Terminated
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Male or menopausal females aged 40 – 86 years
- •2. Negative pregnancy test in women at entry to study with a raised FSH level if under 60yrs old
- •3. Acceptable ECG on entry to study
- •4. An established clinical history consistent with COPD and known chronic hypercapnic respiratory failure on standard treatments
- •5. Arterial gases confirming known hypercapnia with PaO2 below 8.1kPa and arterial carbon dioxide level >7.5 kPa in the absence of an exacerbation
- •6. No use of oxygen or nasal ventilator nor CPAP machine
- •7. Able to comply with questionnaires and assessments
- •8. No history of significant renal or liver failure or uncontrolled hypertension and epilepsy that would preclude the use of modafinil
- •9. No history of significant psychological disturbances
- •10. No drugs that are likely to interact with modafinil
- •11. No evidence of current left cardiac failure
- •12. Compliant with all standard COPD treatments including inhalers, nebulizers and theophyllines and steroids to optimize COPD care
Exclusion Criteria
- •1. Hypercapnic respiratory failure only during an acute COPD exacerbation
- •2. A recognized coexisting respiratory disorder that in the opinion of the investigator would put the patient at risk or invalidate the study outcome measures
- •3. Epilepsy, significant psychological disorders, un-controlled hypertension, known significant liver or kidney disease
- •4. Non-menopausal women including pregnant and breast feeding women or those sexually active and taking contraception (both oral and barrier method). This will be checked by a FSH level also
Investigators
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