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Pilot Trial Of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF) (PPIPF)

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ClinicalTrials.gov Identifier: NCT02085018
Recruitment Status : Completed
First Posted : March 12, 2014
Last Update Posted : November 20, 2017
Newcastle University
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust

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.

Condition or disease Intervention/treatment Phase
Idiopathic Pulmonary Fibrosis Drug: Omeprazole Drug: Matched placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Placebo-controlled Trial of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)
Actual Study Start Date : March 28, 2014
Actual Primary Completion Date : September 27, 2016
Actual Study Completion Date : September 27, 2016

Arm Intervention/treatment
Experimental: Omeprazole
Omeprazole 20 milligrams twice a day taken for 90 days
Drug: Omeprazole
Other Name: Losec

Placebo Comparator: Matched placebo
Matched placebo twice a day taken for 90 days
Drug: Matched placebo
Matched placebo

Primary Outcome Measures :
  1. objectively measured cough frequency [ Time Frame: 90 days ]
    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.

Secondary Outcome Measures :
  1. symptoms of cough [ Time Frame: 90 days ]
    change in symptoms of cough at the end of treatment as measured by validated cough questionnaire

  2. reflux symptoms [ Time Frame: 90 days ]
    change in symptoms of reflux as measured by validated questionnaires

  3. acid and non-acid reflux [ Time Frame: 90 days ]
    change in acid and non-acid reflux measured by oesophageal physiological study

  4. vital capacity (VC) & transfer factor for carbon monoxide (Tco) [ Time Frame: 90 days ]
    change in VC and Tco as measured by lung function tests

  5. 6 minute walk distance [ Time Frame: 90 days ]
    change in 6 minute walk distance from baseline to 90 days

  6. assess amount of inflammation in lung [ Time Frame: 90 days ]
    assess markers of lung inflammation in bronchoalveolar lavage (BAL) fluid (eg. concentration of transforming growth factor beta, interleukin-8 etc.)

  7. lung infection rate [ Time Frame: 90 days ]
    assess bronchoalveolar lavage (BAL) fluid for infections over period from baseline to 90 days, also patient reported infection in adverse event diary

  8. adverse events rate [ Time Frame: 90 days ]
    patient reported adverse events, assess lung infection rate in bronchoalveolar fluids over period from baseline to 90 days

Other Outcome Measures:
  1. rate of recruitment [ Time Frame: 18 months ]
    Number of participants eligible and consented for study

  2. rate of study completion [ Time Frame: 18 months ]
    Number of participants completing all study procedures (over 90 days for each participant)

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02085018

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United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle University
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Study Director: John Simpson, FRCP Newcastle University
Principal Investigator: Ian Forrest, MRCP Newcastle upon Tyne Hospitals NHS Foundation Trust
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Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02085018    
Other Study ID Numbers: IAFIPF001
2013-003301-26 ( EudraCT Number )
IPFPSG12-7 ( Other Grant/Funding Number: British Lung Foundation )
13/YH/0284 ( Other Identifier: Research Ethics Committee )
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: November 20, 2017
Last Verified: November 2017
Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
omeprazole, idiopathic pulmonary fibrosis
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action