Idiopathic Pulmonary Fibrosis (IPF) MedDRA version: 19.0 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Omeprazole (UK licensed generic product)
Product Name: Omeprazole
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: Omeprazole
CAS Number: 73590-58-6
Concentration u
Sponsors
Newcastle Upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A pragmatic clinical definition of IPF will be used, in which recruited patients must fulfill all of the following criteria • IPF is considered the most likely diagnosis by the regional interstitial lung disease multidisciplinary team meeting (ILD-MDT) • history of cough, with or without exertional dyspnoea • high resolution computed tomography (HRCT) scan features of honeycombing in a predominantly basal and subpleural distribution • bibasal crackles on auscultation • features of a restrictive ventilatory defect (vital capacity (VC) =65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: • known allergy to omeprazole or other PPI • concomitant use of warfarin, diazepam, phenytoin or ketoconazole • concomitant use of a regular PPI, antacid, prokinetic or raft alginate during the trial period. • history of upper respiratory tract infection, lower respiratory tract infection or exacerbation of IPF in the 4 weeks before starting study drugs • active trial of treatment for IPF (eg prednisolone, pirfenidone, nintedanib, N-acetylcysteine) started in the 4 weeks before starting study drugs • documented history of hepatic cirrhosis • pregnancy or lactation • ILD-MDT considers the most likely cause of the patient’s ILD to be a condition other than IPF, for example rheumatoid lung, systemic sclerosis ILD, asbestosis, chronic hypersensitivity pneumonitis, sarcoidosis, etc. • concurrent enrolment in a trial of a CTIMP for IPF
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal question is whether omeprazole reduces cough (quantified objectively) in patients with IPF, when compared with placebo. ;Secondary Objective: Secondary questions include whether omeprazole (as compared with placebo): - causes less acid reflux and non-acid reflux - reduces symptoms of cough and reflux - makes any difference to lung function - reduces lung inflammation - is associated with a difference in the distance the patient can walk in 6 minutes - changes the frequency of lung infection - increases side effects.;Primary end point(s): Primary Efficacy outcome: Change in cough frequency between baseline and the end of treatment. Feasibility outcomes : • Rates of eligibility, recruitment, randomization and study completion • Feasibility and acceptability of trial procedures ;Timepoint(s) of evaluation of this end point: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 3 months;Secondary end point(s): The following outcomes, proposed as secondary efficacy outcomes for any future trial, will be measured, with the focus of analysis being on data yield and quality • Change in symptoms of cough at the end of treatment • Change in symptoms of reflux at the end of treatment • Change in acid and non-acid reflux after treatment • Change in VC and Tco at the end of treatment • Change in 6 minute walk distance at the end of treatment • Markers of lung inflammation in bronchoalveolar lavage (BAL) fluid at the end of treatment (eg concentration of transforming growth factor beta, interleukin-8 etc) • Change in lung infection in BAL fluid at the end of treatment • Patient-reported adverse events | — |
Countries
United Kingdom
Outcome results
None listed