Clinical trial of V3381 in chronic cough

ISRCTN	ISRCTN66679782
DOI	https://doi.org/10.1186/ISRCTN66679782
ClinicalTrials.gov (NCT)	NCT01401673
Protocol serial number	V001; G0701918
Sponsor	Vernalis (R&D) Ltd (UK)
Funder	Medical Research Council (MRC) (UK) (ref: 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

Education and Research Centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Study information

Primary study design	Interventional
Study design	Non-randomised single arm open-label study
Secondary study design	Non randomised controlled trial
Study type	Participant 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
Phase	Phase II
Drug / device / biological / vaccine name(s)	V3381
Primary outcome measure(s)	Objective cough frequency over 24 hours at 8 weeks of treatment compared to baseline.
Key secondary outcome measure(s)	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
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
England

Study participating centre

Education and Research Centre

Manchester
M23 9LT
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

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