Condition category
Signs and Symptoms
Date applied
08/09/2010
Date assigned
13/12/2010
Last edited
28/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ashley Woodcock

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

V001; G0701918

Study information

Scientific title

Phase II open label pilot study of V3381 in chronic cough

Acronym

Study hypothesis

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

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

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 names

V3381

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

01/10/2009

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

10

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

01/10/2009

Recruitment end date

01/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Education and Research Centre
Manchester
M23 9LT
United Kingdom

Sponsor information

Organisation

Vernalis (R&D) Ltd (UK)

Sponsor details

Oakdene Court
613 Reading Road
Winnersh
Berkshire
RG41 5UA
United Kingdom

Sponsor type

Industry

Website

http://www.vernalis.com/

Funders

Funder type

Research council

Funder name

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

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

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

28/10/2016: No publications found, verifying study status with principal investigator