E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hypercapnic respiratory failure in COPD |
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E.1.1.1 | Medical condition in easily understood language |
Chronic obstructive pulmonary disease with type-2 respiratory failure where blood carbon dioxide levels are chronically raised due to inability of the lungs to breathe at an adequate rate. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
1.Tolerability 2.Improve day and overnight oxygen levels measured by oximetry. 3.Improve quality of life scores 4.Spirometry |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement in arterial gas abnormalities:- % reduction in PaCO2 reduction and % increase in PaO2 at 10 and 40 days |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1-4 weeks before study start and at day 10 and day 40 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of trial will be the last patient completing attendance at 40 days. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |