Hypercapnic respiratory failure in COPD
Conditions
Interventions
Trade Name: modafinil
Product Name: modafinil dry powder tablet
Product Code: Pl 16260/0002
Pharmaceutical Form: Tablet
INN or Proposed INN: modafinil
CAS Number: ATC N06BA07
Current Sponsor code: PL1
Sponsors
Epsom and St Helier University Hospitals NHS Trust R&D Dpt
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does oral modafinil improve arterial oxygen levels and reduce arterial carbon dioxide levels in patients with chronic hypercapnic respiratory failure and COPD. We will look at percentage improvement in oxygen levels and percentage reduction in carbon dioxide levels.;Secondary Objective: 1.Tolerability 2.Improve day and overnight oxygen levels measured by oximetry. 3.Improve quality of life scores 4.Spirometry;Primary end point(s): Improvement in arterial gas abnormalities:- % reduction in PaCO2 reduction and % increase in PaO2 at 10 and 40 days;Timepoint(s) of evaluation of this end point: DaY 10 and day 40 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1 Improved Epworth sleepiness score 2. Improved BODE scores. 3. Any effect on the GAD-7 anxiety and depression score due to taking modafinil 4. Lung function tests 5. Oxygen saturation (day and night);Timepoint(s) of evaluation of this end point: 1-4 weeks before study start and at day 10 and day 40 | — |
Countries
United Kingdom
Contacts
Public ContactManager of R&D Dept St Helier Hosp
Yvonne Reilly
Outcome results
None listed