E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic and treatment resistant Chronic Cough |
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E.1.1.1 | Medical condition in easily understood language |
Coughing that has persistent for at least 8 weeks with no apparent cause or that does not respond to treatment of any apparent underlying cause. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066656 |
E.1.2 | Term | Chronic cough |
E.1.2 | System Organ Class | 100000004855 |
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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 |
To evaluate the change in cough frequency in chronic cough patients after treatment with Memantine by assessing 24 hour cough recordings. |
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E.2.2 | Secondary objectives of the trial |
(i) To evaluate the change in Cough-Specific Quality-of-Life Questionnaire (CQLQ) score after treatment with Memantine.
(ii) To record the Global Rating of Change for cough frequency and severity after treatment with Memantine.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Chronic cough (>8 weeks); - Normal chest x-ray; - FEV1 and FVC >70% predicted measured using spirometry; - Idiopathic or treatment resistant chronic cough, defined as a cough for which no objective evidence of an underlying trigger can be determined after routine clinical investigation (idiopathic) or a cough that did not respond to standard treatment for identified underlying triggers (treatment-resistant); - Females will be non-pregnant and non-lactating with no intention of pregnancy during study treatment.
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E.4 | Principal exclusion criteria |
- Recent upper respiratory tract infection (<4 weeks); - Pregnancy/breast-feeding. Women of childbearing potential (not >1 years post-menopausal and/or not surgically sterilised) must have a negative blood serum pregnancy test, performed at visit 1 prior to administration of study medication. - Current smokers or ex-smokers with <6 months abstinence or cumulative history of >20 pack years; - Current treatment with ACE inhibitors; - Drug or alcohol abuse; - Uncontrolled hypertension (i.e., >160/100 mmHg despite adequate medical therapy); - Recent myocardial infarction, or history of congestive cardiac failure; - Any clinically significant neurological disorder; - Prior renal transplant, current renal dialysis, patients with creatinine clearance <30ml/min or history of renal tubular acidosis; - Severe hepatic impairment; - Fructose intolerance; - Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient’s ability to participate in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in objectively recorded cough frequency in chronic cough patients after treatment with memantine. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
This endpoint will be calculated from the baseline cough frequency (pre-treatment) and the cough frequency on the final day of 4 weeks treatment with the maximal tolerated dose of memantine. |
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E.5.2 | Secondary end point(s) |
Change in cough specific quality of life Global Rating of Change Score |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
These endpoints will be calculated from the baseline measures (pre-treatment), those performed at prior to each increase in dose of therapy and on the final day of 4 weeks treatment with the maximal tolerated dose of memantine. |
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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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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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1-2 weeks after the last visit of every patient a follow up call will be made and a global rating of change scale score recorded. This will be considered the end of the trial. |
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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 | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |