Condition category
Signs and Symptoms
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Ashley Woodcock


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number

V001; G0701918

Study information

Scientific title

Phase II open label pilot study of V3381 in chronic cough


Study hypothesis

We hypothesise that 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

North West Research Ethics Committee approved on the 28th August 2009 (ref: 09/H1010/39)

Study design

Non-randomised single arm open-label study

Primary study design


Secondary study design

Non randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Chronic cough


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



Phase II

Drug names


Primary outcome measures

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 trial start date


Overall trial end date


Reason abandoned


Participant 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)

Participant type


Age group




Target number of participants


Participant 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)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Education and Research Centre
M23 9LT
United Kingdom

Sponsor information


Vernalis (R&D) Ltd (UK)

Sponsor details

Oakdene Court
613 Reading Road
RG41 5UA
United Kingdom

Sponsor type




Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0701918)

Alternative name(s)


Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit


United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes