Pilot trial of omeprazole in idiopathic pulmonary fibrosis (PPIPF Study)

Not Applicable

Completed

• Conditions: Idiopathic Pulmonary Fibrosis - Respiratory (Chest) Disease; Respiratory; Other interstitial pulmonary diseases with fibrosis

• Registration Number: ISRCTN07139948
• Lead Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-11
• Study Completion: 2016-09-30
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

A pragmatic clinical definition of IPF will be used, in which recruited patients must fulfill all of the following criteria:

1. IPF is considered the most likely diagnosis by the regional interstitial lung disease multidisciplinary team meeting
(ILD-MDT)
2. History of cough, with or without exertional dyspnoea
3. High resolution computed tomography (HRCT) scan features of honeycombing in a predominantly basal and subpleural distribution
4. Bibasal crackles on auscultation
5. Features of a restrictive ventilatory defect (vital capacity (VC) <90% predicted and/or diffusion factor for carbon monoxide (Tco) <90% predicted)
6. Aged 40-85 years

Patients with radiological emphysema will be eligible so long as the diagnosis of IPF is secure, i.e., 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 two 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 ongoing treatment will be reviewed.
1. Patients taking short courses (e.g., 2 months) of PPI will be eligible once the treatment has been discontinued for a minimum of 1 month.
2. 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 he/she agrees and provides written consent to a trial of discontinuation, the GP will be contacted. If
both the patient and the GP agree to a trial of discontinuation, the patient will be eligible for the study if he/she provides written consent after at least 2 weeks without PPI.
3. 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.
4. Target Gender: Male & Female; Upper Age Limit 85 years ; Lower Age Limit 40 years

Exclusion Criteria

1. Known allergy to omeprazole or other PPI
2. Concomitant use of warfarin, diazepam, phenytoin or ketoconazole
3. Concomitant use of a regular PPI, antacid, prokinetic or raft alginate during the trial period.
4. History of upper respiratory tract infection, lower respiratory tract infection or exacerbation of IPF in the 4 weeks before starting study drugs
5. Active trial of treatment for IPF (e.g., prednisolone, pirfenidone, N-acetylcysteine) started in the 4 weeks before starting study drugs
6. Documented history of hepatic cirrhosis
7. Pregnancy or lactation
8. 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.
9. Concurrent enrolment in a trial of a Clinical Trials of Investigational Medicinal Product (CTIMP) for IPF

Study & Design

• Study Type: Interventional
• Study Design: Not specified