Chronic cough in Idiopathic Pulmonary Fibrosis MedDRA version: 16.1 Level: LLT Classification code 10066656 Term: Chronic cough System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 16.1 Level: PT Classification code 10011224 Term: Cough System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: VRP700
Product Code: VRP700
Pharmaceutical Form: Inhalation powder
Current Sponsor code: VRP700
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration
Sponsors
Verona Pharma plc
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 To assess the impact of VRP700 on the Global Rating of Change scale To assess the safety of VRP700, and how well it is tolerated To evaluate the effectiveness of VRP700 on the sensation of dyspnoea | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess patients' treatment preferences To assess the impact of VRP700 on the Global Rating of Change Scale To assess the safety of VRP700 and how well it is tolerated 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 Change in number of coughs each hour for 24 hours, compared to baseline Cough severity score VAS measured at baseline, pre-dose, 1hr, 2hr, 4hr, end of day and 24 hour post dose Urge to cough severity score VAS measured at baseline, pre-dose, 1hr, 2hr, 4hr, end of day Global rating of change scale at 4hr post-dose Subject's treatment preference at the end of study assessment | — |
Countries
United Kingdom
Contacts
Public ContactKathy Banner
Verona Pharma Plc
Outcome results
None listed