Clinical trial of V3381 in chronic cough
| ISRCTN | ISRCTN66679782 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66679782 |
| ClinicalTrials.gov number | NCT01401673 |
| Secondary identifying numbers | V001; G0701918 |
- Submission date
- 08/09/2010
- Registration date
- 13/12/2010
- Last edited
- 06/12/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Ashley Woodcock
Scientific
Scientific
Education and Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
Study information
| Study design | Non-randomised single arm open-label study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Phase II open label pilot study of V3381 in chronic cough |
| Study objectives | Cough reflex hypersensitivity, demonstrated in chronic cough patients, is due to a phenomenon known as central sensitisation, mediated by the N-methyl d-aspartate (NMDA) receptor. |
| Ethics approval(s) | North West Research Ethics Committee approved on the 28th August 2009 (ref: 09/H1010/39) |
| Health condition(s) or problem(s) studied | Chronic cough |
| Intervention | 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) was completed by patients after 2 weeks, 4 weeks and 8 weeks of treatment. Twenty-four hour objective cough monitoring was performed at baseline and after 4 and 8 weeks of treatment using a custom-built recording device. All adverse events were documented. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | V3381 |
| Primary outcome measure | Objective cough frequency over 24 hours at 8 weeks of treatment compared to baseline. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/10/2009 |
| Completion date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 10 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 01/10/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Education and Research Centre
Manchester
M23 9LT
United Kingdom
M23 9LT
United Kingdom
Sponsor information
Vernalis (R&D) Ltd (UK)
Industry
Industry
Oakdene Court
613 Reading Road
Winnersh
Berkshire
RG41 5UA
United Kingdom
| Website | http://www.vernalis.com/ |
|---|---|
"ROR" |
https://ror.org/027p78k86 |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK) (ref: G0701918)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
06/12/2019: The NCT code has been added.
06/12/2019: No publications found, verifying study status with principal investigator
28/10/2016: No publications found, verifying study status with principal investigator
