A clinical trial to assess whether a treatment reducing acid production in the stomach (omeprazole) can reduce cough in patients with scarring of the lungs.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]MedDRA version: 19.0Level: PTClassification code 10021240Term: Idiopathic pulmonary fibrosisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
- Registration Number
- EUCTR2013-003301-26-GB
- Lead Sponsor
- ewcastle Upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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) <90% predicted and/or diffusion factor for carbon monoxide (Tco) <90% predicted)
•aged 40-85 years
Patients with radiological emphysema will be eligible so long as the diagnosis of IPF is secure, ie all the features above are satisfied.
If the regional ILD-MDT cannot reach a clear consensus as to the diagnosis, the case will be referred to 2 experts in ILD from outside the region, and the patient will be eligible if both consider IPF to be the most likely diagnosis.
Patients taking a PPI during screening will potentially be eligible. In these cases the indication for on-going treatment will be reviewed.
•Patients taking short courses (eg 2 months) of PPI will be eligible once the treatment has been discontinued for a minimum of 1 month.
•There are few licensed indications for long-term omeprazole other than Zollinger-Ellison syndrome. Therefore, unless there is a known diagnosis of Zollinger-Ellison or a history of significant dyspepsia or gastrointestinal bleeding during a previous discontinuation of PPI, patients on long-term PPI will be asked to consider a trial of supervised discontinuation.
If patients taking omeprazole (or a related stomach treatment) wish to take part, we shall contact the GP to check that the GP is aware and in agreement. The patient will then be asked to sign a consent form to agree to try a period off treatment for 2 weeks. If symptoms return during that 2- week period the patient should go back on treatment and not take part in the study. If patients manage well without the treatment for 2 weeks, they will be asked to sign a second consent form before starting the study.
Patients taking antacids, prokinetics or raft alginates at the time of screening will be eligible if they have been off these treatments for a period of at least 2 weeks.
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The principal question is whether omeprazole reduces cough (quantified objectively) in patients with IPF, when compared with placebo.<br><br>;Secondary Objective: Secondary questions include whether omeprazole (as compared with placebo):<br>- causes less acid reflux and non-acid reflux<br>- reduces symptoms of cough and reflux<br>- makes any difference to lung function<br>- reduces lung inflammation<br>- is associated with a difference in the distance the patient can walk in 6 minutes<br>- changes the frequency of lung infection<br>- increases side effects.;Primary end point(s): Primary Efficacy outcome:<br><br> Change in cough frequency between baseline and the end of treatment.<br><br>Feasibility outcomes :<br><br> • Rates of eligibility, recruitment, randomization and study completion<br> • Feasibility and acceptability of trial procedures<br>;Timepoint(s) of evaluation of this end point: 3 months
- Secondary Outcome Measures
Name Time Method 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<br><br> •Change in symptoms of cough at the end of treatment <br> •Change in symptoms of reflux at the end of treatment<br> •Change in acid and non-acid reflux after treatment<br> •Change in VC and Tco at the end of treatment<br> •Change in 6 minute walk distance at the end of treatment<br> •Markers of lung inflammation in bronchoalveolar lavage (BAL) fluid at the end of treatment (eg concentration of transforming growth factor beta, interleukin-8 etc)<br> •Change in lung infection in BAL fluid at the end of treatment<br> •Patient-reported adverse events<br>