E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Treatment resistant and Idiopathic Chronic Cough |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10066656 |
E.1.2 | Term | Chronic cough |
|
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 |
This is a pilot evaluation of the safety and efficacy of V3381 in treating chronic cough.
|
|
E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Male or female 18-75 years of age •Females must be of non child-bearing potential (ie. Surgically sterilised or >1 year post-menopause). Male subjects who are sexually active with a female partner of child-bearing potential must agree to use a barrier method of contraception for the duration of the study, •Chronic Cough ( > 8 weeks) •Normal Chest X-ray •Normal Lung Function •Idiopathic or treatment resistant cough (defined as a cough for which no objective evidence of an underlying trigger can be determined after investigation (idiopathic) or a cough that is unresponsive to 8 weeks of targeted treatment for identified underlying triggers including reflux disease, asthma and post-nasal drip (treatment-resistant)).
|
|
E.4 | Principal exclusion criteria |
•Recent upper respiratory tract infection (<4 weeks) •Pregnancy/breast-feeding •Current smokers or ex-smokers with <6 months abstinence or cumulative history of >10 pack years •Current treatment with ACE inhibitors. •Drug or alcohol abuse •Uncontrolled hypertension (i.e., >140/90 mmHg despite adequate medical therapy). •Any cardiovascular condition that would be a contra-indication to the use of sympathomimetic amines (e.g. active angina). •Any clinically significant neurological disorder •Prior renal transplant, current renal dialysis. •Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient’s ability to participate in the study. •Increased risk of seizures (defined as a history of seizure disorder, family history of seizures and history of head trauma that resulted in loss of consciousness or concussion). •Any malignancy in the past 2 years (with the exception of basal cell carcinoma). •Use of opioids, anticonvulsants, antidepressants (particularly MAO inhibitors). Patients currently taking drugs in these classes for chronic cough may have them discontinued prior to entry into the study. Selective serotonin reuptake inhibitors should be discontinued at least 4 weeks prior to study; all other prohibited medications should be discontinued 2 weeks prior to study. Patients should not be taking NMDA-receptor antagonists or sympathomimetics during the study period. •Any clinically significant abnormal laboratory test result(s). •Serum creatinine laboratory value greater than 1.5 x upper limit of normal (ULN) reference range (after adjustment for age) or estimated creatinine clearance <60 mL/min. •Total bilirubin greater than upper limit of normal reference range (with the exception of Gilbert’s Syndrome) and/or alanine transaminase (ALT) >1.5 times upper limit of normal reference ranges (after adjustment for age). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
a) Primary Safety Endpoint: safety of V3381 determined by clinical assessment, AEs, vital signs, ECG and safety laboratory tests.
b) Primary Efficacy Endpoint: objective cough frequency at 8 weeks compared to baseline.
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
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 | 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
Once 10 patients have completed the study, the results will be reviewed by an independent data monitoring committee and a decision made about further recruitment to a total of 20 patients. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 2 |