Clinical trial: Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF) (NCT02085018)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 47-year-old man comes to the office for routine checkup. He is complaining of chronic cough and occasional but progressive dyspnea.  Other medical conditions include hypertension and osteoarthritis.  The patient smokes a pack of cigarettes daily and does not use alcohol or illicit drugs.  He used to be a construction worker. On examination, there are decreased breath sounds and percussive dullness at the base of both lungs.  Chest CT scan reveals a mild bilateral pleural effusion and diffuse thickening of the pleura. The patient's documents show chronic exposure to asbestosis. The specimen of the lungs reveled  pulmonary fibrosis that is most predominant in the lower lobes, characterized  by the presence of asbestos bodies (golden-brown beaded rods with translucent centers).

Patient description (patient's own words): I'm a 47-year-old former construction worker. I'm a man and I smoke a pack of cigs a day but I don't drink or do drugs. I went to my routine checkup because I've been coughing so much lately. I also had shortness of breath and it got worse over time. I already suffer from hypertension and osteoarthritis. My doctor found that I have decreased breath sounds. I did a chest scan and it seems that I have fluid around my lungs, and the lining of my lungs has become thicker in many areas. I have been exposed a lot to asbestos fibers. The other lung exam showed that I have pulmonary fibrosis, especially in the lower part of my lungs and they found some asbestos there.

Does the patient match the trial criteria? Entailment