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    Summary
    EudraCT Number:2013-003301-26
    Sponsor's Protocol Code Number:IAFIPF001
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-11-04
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2013-003301-26
    A.3Full title of the trial
    A randomised placebo-controlled pilot trial of omeprazole in idiopathic pulmonary fibrosis (IPF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to assess whether a treatment reducing acid production in the stomach (omeprazole) can reduce cough in patients with scarring of the lungs.
    A.3.2Name or abbreviated title of the trial where available
    Pilot trial of omeprazole in idiopathic pulmonary fibrosis (Acronym :
    A.4.1Sponsor's protocol code numberIAFIPF001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN07139948
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNewcastle Upon Tyne Hospitals NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBritish Lung Foundation
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Omeprazole (UK licensed generic product)
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOmeprazole
    D.3.4Pharmaceutical form Gastro-resistant capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOmeprazole
    D.3.9.1CAS number 73590-58-6
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Idiopathic Pulmonary Fibrosis (IPF)
    E.1.1.1Medical condition in easily understood language
    Scarring of the lungs of unknown cause
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal question is whether omeprazole reduces cough (quantified objectively) in patients with IPF, when compared with placebo.
    E.2.2Secondary objectives of the trial
    Secondary questions include whether omeprazole (as compared with placebo):
    - causes less acid reflux and non-acid reflux
    - reduces symptoms of cough and reflux
    - makes any difference to lung function
    - reduces lung inflammation
    - is associated with a difference in the distance the patient can walk in 6 minutes
    - changes the frequency of lung infection
    - increases side effects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A pragmatic clinical definition of IPF will be used, in which recruited patients must fulfill all of the following 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 and 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 with radiological emphysema will be eligible so long as the diagnosis of IPF is secure, ie all the features above are satisfied.

    If the regional ILD-MDT cannot reach a clear consensus as to the diagnosis, the case will be referred to 2 experts in ILD from outside the region, and the patient will be eligible if both consider IPF to be the most likely diagnosis.
    Patients taking a PPI during screening will potentially be eligible. In these cases the indication for on-going treatment will be reviewed.
    • Patients taking short courses (eg 2 months) of PPI will be eligible once the treatment has been discontinued for a minimum of 1 month.
    • There are few licensed indications for long-term omeprazole other than Zollinger-Ellison syndrome. Therefore, unless there is a known diagnosis of Zollinger-Ellison or a history of significant dyspepsia or gastrointestinal bleeding during a previous discontinuation of PPI, patients on long-term PPI will be asked to consider a trial of supervised discontinuation.
    If patients taking omeprazole (or a related stomach treatment) wish to take part, we shall contact the GP to check that the GP is aware and in agreement. The patient will then be asked to sign a consent form to agree to try a period off treatment for 2 weeks. If symptoms return during that 2- week period the patient should go back on treatment and not take part in the study. If patients manage well without the treatment for 2 weeks, they will be asked to sign a second consent form before starting the study.

    Patients taking antacids, prokinetics or raft alginates at the time of screening will be eligible if they have been off these treatments for a period of at least 2 weeks.
    E.4Principal exclusion criteria
    • known allergy to omeprazole or other PPI
    • concomitant use of warfarin, diazepam, phenytoin or 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 (eg prednisolone, pirfenidone, nintedanib, 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 the patient’s ILD to be a condition other than IPF, for example rheumatoid lung, systemic sclerosis ILD, asbestosis, chronic hypersensitivity pneumonitis, sarcoidosis, etc.
    • concurrent enrolment in a trial of a CTIMP for IPF
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy outcome:

    Change in cough frequency between baseline and the end of treatment.

    Feasibility outcomes :

    • Rates of eligibility, recruitment, randomization and study completion
    • Feasibility and acceptability of trial procedures
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    E.5.2Secondary end point(s)
    The following outcomes, proposed as secondary efficacy outcomes for any future trial, will be measured, with the focus of analysis being on data yield and quality

    • Change in symptoms of cough at the end of treatment
    • Change in symptoms of reflux at the end of treatment
    • Change in acid and non-acid reflux after treatment
    • Change in VC and Tco at the end of treatment
    • Change in 6 minute walk distance at the end of treatment
    • Markers of lung inflammation in bronchoalveolar lavage (BAL) fluid at the end of treatment (eg concentration of transforming growth factor beta, interleukin-8 etc)
    • Change in lung infection in BAL fluid at the end of treatment
    • Patient-reported adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    In the absence of any confirmed benefits for omeprazole in IPF, or any licensed indication for long-term omeprazole in IPF, there are no plans to routinely prescribe PPI after the study ends. However, where patients give a clear history of reflux during the study, we have the capacity to prescribe omeprazole after the study ends on a case-by-case basis. All patients in the study will be followed up in the Interstitial Lung Disease Clinic, where enquiry about reflux symptoms is routine.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-27
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