Chronic cough Signs and Symptoms Cough
Conditions
Interventions
Patients received treatment with V3381 for 8 weeks and attended for study visits after 1 week, 2 weeks, 4 weeks and 8 weeks of treatment. A validated cough-specific quality of life questionnaire (CQLQ
Sponsors
Vernalis (R&D) Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 18 - 75 years of age 2. Females must be of non child-bearing potential (i.e., surgically sterilised or greater than 1 year post-menopause). Male patients 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. 3. Chronic cough (greater than 8 weeks) 4. Normal chest X-ray 5. Normal lung function 6. 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)
Exclusion criteria
Exclusion criteria: 1. Recent upper respiratory tract infection (less than 4 weeks) 2. Pregnancy/breast-feeding 3. Current smokers or ex-smokers with less than 6 months abstinence or cumulative history of greater than 10 pack years 4. Current treatment with angiotensin converting enzyme (ACE) inhibitors 5. Drug or alcohol abuse 6. Uncontrolled hypertension (i.e., greater than 140/90 mmHg despite adequate medical therapy) 7. Any cardiovascular condition that would be a contra-indication to the use of sympathomimetic amines (e.g. active angina) 8. Any clinically significant neurological disorder 9. Prior renal transplant, current renal dialysis 10. Any clinically significant or unstable medical or psychiatric condition that would interfere with the patient's ability to participate in the study 11. 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) 12. Any malignancy in the past 2 years (with the exception of basal cell carcinoma) 13. Use of opioids, anticonvulsants, antidepressants (particularly monoaminde oxidase [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. 14. Any clinically significant abnormal laboratory test result(s) 15. Serum creatinine laboratory value greater than 1.5 x upper limit of normal (ULN) reference range (after adjustment for age) or estimated creatinine clearance less than 60 ml/min 16. Total bilirubin greater than upper limit of normal reference range (with the exception of Gilbert's syndrome) and/or alanine transaminase (ALT) greater than 1.5 times upper limit of normal reference ranges (after adjustment for age)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective cough frequency over 24 hours at 8 weeks of treatment compared to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective cough frequency over 24 hours at 4 weeks of treatment compared to baseline 2. Cough-related quality of life at 2, 4 and 8 weeks of treatment compared to baseline 3. Treatment-related adverse events | — |
Countries
United Kingdom
Outcome results
None listed