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)

• Register: EUCTR
• Last refreshed on: 18 November 2013
• Main ID: EUCTR2012-005794-31-GB
• Date of registration: 26/02/2013
• Prospective Registration: Yes
• Primary sponsor: Verona Pharma plc
• Public title: 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)
• Scientific title: A randomised, double-blind, placebo-controlled crossover study to assess the efficacy of a single dose of 100mg of VRP700 by inhalation in reducing the frequency and severity of cough in adult patients with Idiopathic Pulmonary Fibrosis - EPOCh
• Date of first enrolment: 25/03/2013
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005794-31
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: no Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2

Countries of recruitment

United Kingdom

Contacts

• Name: Kathy Banner
• Affiliation: Verona Pharma Plc

• Name: Kathy Banner
• Affiliation: Verona Pharma Plc

Key inclusion & exclusion 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:
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




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

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

Intervention(s)

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 number: 10-
Pharmaceutical form of the placebo: Inhalation vapour, solution
Route of administration of the placebo: Inhalation use

Primary Outcome(s)

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.

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

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.

Timepoint(s) of evaluation of this end point: Number of coughs during the 4 hour period following the end of nebulisation.

Secondary Outcome(s)

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

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

Secondary ID(s)

VRP700-002-2012