Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)

NCT02085018 | Completed Phase 2

• 4 other identifiers: IAFIPF0012013-003301-26IPFPSG12-713/YH/0284
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Idiopathic pulmonary fibrosis (IPF) is a disease of unknown cause in which areas of normal lung tissue are replaced by scars. As a result it becomes harder for the lungs to extract oxygen from the air. IPF is commonly progressive, and around 50% of patients diagnosed with the disease die after approximately 3 years. The most common, troublesome symptoms of IPF are breathlessness on exertion, and cough. No drug treatments have been unequivocally shown to improve the death rate, or to significantly impact upon symptoms, in IPF. In recent years it has been recognised that cough can be caused by small amounts of liquid coming up from the stomach and "going down the wrong way" into the lungs, a process commonly known as "reflux". As liquid in the stomach is usually acidic, patients' lungs may repeatedly be exposed to small amounts of acid. Reflux is unusually common in IPF and could potentially contribute to the debilitating cough found with the disease. However there are many potential causes for cough in IPF. Stomach acid can be efficiently "switched off" by drugs called "proton pump inhibitors", one of which is called omeprazole. If reflux of stomach acid does contribute to cough in IPF, omeprazole might be expected to reduce cough. The purpose of this study is therefore to test whether omeprazole does reduce cough in patients with IPF. Sixty patients with IPF will be randomly allocated to have 3 months of omeprazole or a placebo. Neither the patient nor the doctor will be aware which treatment has been given, ie this is a randomised "double-blind", placebo--controlled trial. Patients' cough frequency will be measured before and after treatment and the change in cough frequency compared in those receiving omeprazole and those receiving placebo. Change in cough frequency is the main thing we aim to compare, but a range of other measurements will be assessed such as the numbers of patients eligible to take part, agreeing to randomisation and providing outcome data, patients' lung function, symptom scores, the amount of reflux, and the amount of inflammation in the lungs.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

omeprazole, idiopathic pulmonary fibrosis

Outcome Measures

Primary Outcomes (1)

• objectively measured cough frequency

  the change in frequency of objectively measured cough from beginning of the study to the end of treatment (within 2 weeks of completion of treatment). This will be compared in the two groups.

  90 days

Secondary Outcomes (8)

• symptoms of cough

  90 days

• reflux symptoms

  90 days

• acid and non-acid reflux

  90 days

• vital capacity (VC) & transfer factor for carbon monoxide (Tco)

  90 days

• 6 minute walk distance

  90 days

Other Outcomes (2)

• rate of recruitment

  18 months

• rate of study completion

  18 months

Study Arms (2)

Omeprazole

EXPERIMENTAL

Omeprazole 20 milligrams twice a day taken for 90 days

Drug: Omeprazole

Matched placebo

PLACEBO COMPARATOR

Matched placebo twice a day taken for 90 days

Drug: Matched placebo

Interventions

Omeprazole DRUG

Drug

Also known as: Losec

Omeprazole

Matched placebo DRUG

Matched placebo

Matched placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Newcastle-upon-Tyne Hospitals NHS Trust: lead
• Newcastle University: collaborator

Study Sites (1)

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, Tyne & Wear, NE1 4LP, United Kingdom

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• John Simpson, FRCP

  Newcastle University

  STUDY DIRECTOR

• Ian Forrest, MRCP

  Newcastle upon Tyne Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2014
• First Posted: March 12, 2014
• Study Start: March 28, 2014
• Primary Completion: September 27, 2016
• Study Completion: September 27, 2016
• Last Updated: November 20, 2017

Record last verified: 2017-11

Locations

GB (1)