A study to assess the effect of a single-does of VRP700 by inhalation to reduce the frequency and severity of cough in adults with Idiopathic Pulmonary Fibrosis (IPF)

• Conditions: Chronic cough in Idiopathic Pulmonary Fibrosis; MedDRA version: 16.1Level: LLTClassification code 10066656Term: Chronic coughSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 16.1Level: PTClassification code 10011224Term: CoughSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-005794-31-GB
• Lead Sponsor: Verona Pharma plc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02-26
• Last Update Posted: 18 November 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Male or female patients, women (or female partners of male patients) to be of non childbearing potential, or of child bearing potential who either abstain from sexual intercourse, have a sterile partner or practice two medically approved methods of contraception
Aged =18 years
Self-reported history of troublesome daily cough for more than 8 weeks
Self-reported stable clinical condition and cough frequency for more than 4 weeks prior to screening
Diagnosis of idiopathic pulmonary fibrosis following review by a Multi-Disciplinary Team (MDT). The diagnosis of IPF requires the following:
a.Exclusion of other known causes of ILD (e.g. domestic or occupational environmental exposures, connective tissue disease, or drug toxicity) and
b.Either the presence of the usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT) in patients not subjected to surgical lung biopsy
c.Or specific combinations of HRCT and surgical lung biopsy pattern in patients subjected to surgical lung biopsy
Have given written informed consent
Ability to comply with the requirements of the study

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Current smokers, including ‘social smokers’ and those who have given up less than 6 months ago
Concurrent use of medications likely to suppress / affect cough including; immunosuppressives (eg
azathioprine), codeine and related products, morphine, pregabalin, gabapentin, amitriptylline angiotensin
converting enzyme inhibitors (type 1), baclofen or high dose systemic steroids i.e. prednisolone >20mg daily
or equivalent. Those patients on lower doses of steroids for >1 month and still complaining of cough, and
those patients taking Nacetyl
cysteine, and those taking amitriptyline for reasons other than cough may be
included.
Concurrent use of pirfenidone, unless receiving a stable dose for at least 4 weeks prior to Screening
Resting blood oxygen saturation of <90 %
Patients with clinically apparent heart failure or a clinically significant abnormal ECG at Screening
Self-reported history of chest or upper airway infection within the past 4 weeks
Any condition that may affect cough response, such as stroke, Parkinson’s disease or diabetics with autonomic neuropathy. Clinically stable diabetics (i.e. on stable medication for >1 month and not experiencing symptoms of hypoglycaemia) without known autonomic neuropathy may be enrolled
A history of asthma or obstructive airway disease, or those with an FEV1/FVC ratio at screening of <70%
A history of epilepsy or myasthenia gravis
Evidence of significant of hepatic or renal dysfunction
Any clinically significant abnormal laboratory safety test (biochemistry, haematology and dipstick urinalysis) at screening
Pregnancy or breast feeding
Participation in another trial or use of an investigational drug within the preceding 4 weeks
A history of active alcohol abuse or drug addiction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Number of coughs during the 4 hour period following the end of nebulisation.;Primary end point(s): To see how effective a single dose of VRP700 is in reducing how often a patient coughs over 24 hours, and the patients assessment on how severe their cough and their urge to cough is in patients with IPF.;Main Objective: To see how effective a single dose of VRP700 is in reducing how often a patient coughs over 24 hours, and the patients assessment on how severe their cough and their urge to cough is in a patients with IPF.;Secondary Objective: To assess patients’ treatment preferences<br>To assess the impact of VRP700 on the Global Rating of Change scale<br>To assess the safety of VRP700, and how well it is tolerated<br>To evaluate the effectiveness of VRP700 on the sensation of dyspnoea<br><br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To assess patients' treatment preferences<br>To assess the impact of VRP700 on the Global Rating of Change Scale<br>To assess the safety of VRP700 and how well it is tolerated<br>To evaluate the effectiveness of VRP700 on the sensation of dyspnoea;Timepoint(s) of evaluation of this end point: Total number of coughs over 24 hours following the end of nebulisation, compared to baseline, active vs placebo<br>Change in number of coughs each hour for 24 hours, compared to baseline<br>Cough severity score VAS measured at baseline, pre-dose, 1hr, 2hr, 4hr, end of day and 24 hour post dose<br>Urge to cough severity score VAS measured at baseline, pre-dose, 1hr, 2hr, 4hr, end of day <br>Global rating of change scale at 4hr post-dose <br>Subject's treatment preference at the end of study assessment