A pilot study of modafinil add to standard care in Type-2 respiratory failure in COPD

• Conditions: Hypercapnic respiratory failure in COPD; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-005107-13-GB
• Lead Sponsor: Epsom and St Helier University Hospitals NHS Trust R&D Dpt

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-08-28
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified