Treatment resistant and Idiopathic Chronic Cough MedDRA version: 9.1 Level: LLT Classification code 10066656 Term: Chronic cough
Conditions
Sponsors
Vernalis (R&D) Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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)). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: •Recent upper respiratory tract infection (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 1.5 times upper limit of normal reference ranges (after adjustment for age).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This is a pilot evaluation of the safety and efficacy of V3381 in treating chronic cough. ;Secondary Objective: ;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. | — |
Countries
United Kingdom
Outcome results
None listed