Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)

Launched by NEWCASTLE-UPON-TYNE HOSPITALS NHS TRUST · Mar 10, 2014

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Eligibility criteria

• Inclusion 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 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 taking short courses (eg. 2 months) of proton pump inhibitors (PPI) will be eligible once the treatment has been discontinued for a minimum of 1 month.
• Exclusion Criteria:
• • Known allergy to Omeprazole or other proton pump inhibitor.
• • Concomitant use of warfarin, diazepam, phenytoin, 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 9eg. prednisolone, pirfenidone, 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 he patient's ILD to be a condition other than IPF (eg. rheumatoid lung, systemic sclerosis ILD, asbestosis, chronic hypersensitivity pneumonitis, sarcoidosis, etc.).
• • Concurrent enrolment in a trial of a Clinical Trial of Investigational Medicinal Product (CTIMP) for IPF.