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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Newcastle-upon-Tyne Hospitals NHS Trust
Sponsor:
Collaborator:
Newcastle University
Information provided by (Responsible Party):
Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT02085018
First received: February 9, 2014
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Omeprazole
Drug: Matched placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised, Placebo-controlled Trial of Omeprazole in Idiopathic Pulmonary Fibrosis (IPF)

Resource links provided by NLM:


Further study details as provided by Newcastle-upon-Tyne Hospitals NHS Trust:

Primary Outcome Measures:
  • objectively measured cough frequency [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    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:
  • symptoms of cough [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    change in symptoms of cough at the end of treatment as measured by validated cough questionnaire

  • reflux symptoms [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    change in symptoms of reflux as measured by validated questionnaires

  • acid and non-acid reflux [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    change in acid and non-acid reflux measured by oesophageal physiological study

  • vital capacity (VC) & transfer factor for carbon monoxide (Tco) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    change in VC and Tco as measured by lung function tests

  • 6 minute walk distance [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    change in 6 minute walk distance from baseline to 90 days

  • assess amount of inflammation in lung [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    assess markers of lung inflammation in bronchoalveolar lavage (BAL) fluid (eg. concentration of transforming growth factor beta, interleukin-8 etc.)

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

  • adverse events rate [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    patient reported adverse events, assess lung infection rate in bronchoalveolar fluids over period from baseline to 90 days


Other Outcome Measures:
  • rate of recruitment [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Number of participants eligible and consented for study

  • rate of study completion [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Number of participants completing all study procedures (over 90 days for each participant)


Estimated Enrollment: 60
Study Start Date: February 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omeprazole
Omeprazole 20 milligrams twice a day taken for 90 days
Drug: Omeprazole
Drug
Other Name: Losec
Placebo Comparator: Matched placebo
Matched placebo twice a day taken for 90 days
Drug: Matched placebo
Matched placebo
Other Name: Matched Placebo

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02085018

Contacts
Contact: Prosenjit Dutta, MRCP +44(0)1912087770 prosenjit.dutta@ncl.ac.uk
Contact: Barnes Jane, MSc +44(0)1912087249 jane.barnes@newcastle.ac.uk

Locations
United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE1 4LP
Principal Investigator: Ian Forrest, MRCP         
Sub-Investigator: Chris Ward, PhD         
Sub-Investigator: Jacky Smith, MRCP         
Sponsors and Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust
Newcastle University
Investigators
Study Director: John Simpson, FRCP Newcastle University
Principal Investigator: Ian Forrest, MRCP Newcastle upon Tyne Hospitals NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Newcastle-upon-Tyne Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT02085018     History of Changes
Other Study ID Numbers: IAFIPF001, 2013-003301-26, IPFPSG12-7, 13/YH/0284
Study First Received: February 9, 2014
Last Updated: March 10, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Newcastle-upon-Tyne Hospitals NHS Trust:
omeprazole, idiopathic pulmonary fibrosis

Additional relevant MeSH terms:
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014