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    EudraCT Number:2020-000041-14
    Sponsor's Protocol Code Number:269050-80-06-19
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-07-08
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2020-000041-14
    A.3Full title of the trial
    The effectiveness and risks of Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole (TIPAL): a randomised placebo-controlled multi-centre clinical trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number269050-80-06-19
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN13526307
    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 SponsorNorfolk and Norwich University 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 supportNational Institute of Health Research Health Technology Assessment programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNorwich Clinical Trials Unit
    B.5.2Functional name of contact pointMegan Jones
    B.5.3 Address:
    B.5.3.1Street AddressUEA,Earlham Road
    B.5.3.2Town/ cityNorwich
    B.5.3.3Post codeNR4 7TJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01603591224
    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. name Lansoprazole
    D. of the Marketing Authorisation holderAccord-UK Ltd
    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 nameLansoprazole
    D.3.4Pharmaceutical form Capsule
    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 INNlansoprazole
    D.3.9.1CAS number 103577-45-3
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    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 number15
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    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
    E.1.1.1Medical condition in easily understood language
    Pulmonary Fibrosis
    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 21.1
    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 research question of this study asks does lansoprazole slow the deterioration of lung function in idiopathic pulmonary fibrosis patients compared to placebo after 12 months. This will be assessed by the absolute change in percentage predicted (%) forced vital capacity (FVC).
    E.2.2Secondary objectives of the trial
    How patients feel about their coughing and breathlessness, their general quality of life and their quality of life associated with their IPF will be assessed as secondary objectives.

    We will also look at if there is a relationship between the number of times people cough, and their activity and sleep patterns, and the trial treatment over a 24 hour period.

    Risk of sleep apnoea will be assessed by two questionnaires at the end of the study.

    Patients will confirm if the trial treatment is acceptable through a lifestyle questionnaire.

    Patients will report on their reflux symptoms/characteristics and sleep quality intermittently during their participation.

    Another indicator of lung function, the total lung diffusing capacity of carbon monoxide (known as DLCO), will also be assessed where these tests have been completed.

    We will also be assessing if lansoprazole causes more side effects than the placebo, if the trial treatment is acceptable to patients and how the trial treatment im
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The TIPAL cough count, and activity and sleep if applicable, sub-study will be assessed as a secondary outcome outlined within the main trial protocol.

    The relevant secondary outcome is cough frequency over measured using the VitaloJAK cough meter over a 24 hours period assessed at baseline and 3 months post-randomisation. In addition patients participating in the sub-study will also be invited to wear an wrist-based accelerometer during the monitoring period to investigate whether there is a relationship between cough, activity levels and sleep patterns in this patient group as an exploratory investigation.
    E.3Principal inclusion criteria
    1) Male or female, aged greater than or equal to 40 years.
    2) A diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on local or regional multi-disciplinary consensus according to the latest international guidelines (Am J Respir Crit Care Med. 2018;198:e44-e68).
    3) Patients may be receiving licensed anti-fibrotic medication (for at least 4 weeks prior to randomisation with no planned amendments for at least 4 weeks post-randomisation).
    4) Able to provide informed consent.

    Additional inclusion criteria for cough count sub-study:
    1) pre-existing diagnosis of persistent cough (defined as troublesome for more than 8 weeks prior to study enrolment)
    E.4Principal exclusion criteria
    1) Patients unable to comply with study assessments including the ability to complete reliable spirometry assessments.
    2) Concomitant use of a proton pump inhibitor (PPI) or prokinetic drugs (cisapride, domperidone, metoclopramide, erythromycin, pruclopride etc) within 2 weeks prior to randomisation.
    3) Patients with a self-reported respiratory tract infection within 4 weeks of screening (defined as two or more of: increased cough, sputum or breathlessness and requiring antimicrobial therapy).
    4) Significant co-existing respiratory disease (defined as a respiratory condition that exhibits a clinically relevant effect on respiratory symptoms and disease progression as determined by the PI). The presence of bronchiectasis is permitted.
    5) Patients with FEV1/FVC<0.7.
    6) Significant medical, surgical or psychiatric disease that in the opinion of the patient's attending physician would affect subject safety or influence the study outcomes including liver failure (e.g. serum transaminase >2x upper limit of normal (ULN), bilirubin >1.5x ULN (unless the patient has Gilbert's syndrome) and chronic kidney disease (CKD) greater than stage 3, erosive oesophagitis, Barrett's oesophagus or any other condition requiring lifelong proton pump inhibitor use.
    7) Known allergy to proton pump inhibitors or the contents of placebo.
    8) Concomitant use of atazanavir, ketoconazole, itraconazole, tacrolimus, methotrexate, fluvoxamine (see section 6.4.5 of protocol)
    9) Females who are of childbearing potential or lactating. A post-menopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
    10) Receipt of another investigational drug or biological agent associated with another clinical trial within the 4 weeks prior to TIPAL study enrolment or 5 times the drug half-life, whichever is the longer.
    11) Receiving long-term oxygen therapy.
    12) Patients with hypomagesmesmia (defined as magnesium ≤0.6mmol/L).
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change in percentage predicted (%) forced vital capacity (FVC) at 12 months post-randomisation comparing lansoprazole to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary outcome variable, forced vital capacity (FVC), will be measured daily for 5 days at baseline and 12 months post-randomisation to calculate an average of the best value undertaken each day.

    FVC will also be observed at 3 and 6 months post-randomisation to assess if the effect of the intervention is constant over time or varies as time progresses.
    E.5.2Secondary end point(s)
    The following secondary outcomes will be assessed:
    - cough frequency measured by the VitaloJAK cough monitor over a 24 hour period
    - cough score measured using a 100mm visual analogue scale
    - cough related quality of life measured by the Leicester Cough Questionnaire
    - breathlessness measured by the MRC dyspnoea scale
    - disease specific quality of life measured by the King's Brief Interstitial Lung Disease questionnaire
    - health related quality of life measured by the EQ5D-5L questionnaire (quality adjusted life years will be estimated)
    - adverse events with particular relevance to respiratory tract infection including pneumonia, Clostridium difficile infection and hypomagnesaemia
    - total lung diffusing capacity of carbon monoxide (DLCO) (corrected for haemoglobin) where possible
    - laboratory assessment of FVC and FEV1 data where possible
    - sleep quality measured by the short Pittsburgh Sleep Quality Index
    - reflux characteristics measured by the DeMeester score
    - participant acceptability measured by a study-specific lifestyle questionnaire
    - risk of sleep apnoea measured by the STOP-Bang questionnaire
    - progression free survival (with progression defined as time from randomisation to week of all-cause death, lung transplant, 10% reduction in FVC % predicted from baseline)
    - hospital free survival defined as death (all-causes) or first non-elective (all-cause) hospital admission
    - respiratory related hospital free survival
    - decline and rate of decline in absolute %FVC based on %FVC measured weekly
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary outcomes will be assessed as follows:
    - cough frequency at 3 months post-randomisation
    - cough score, cough related quality of life (QoL), breathlessness, disease specific QoL, health related QoL, and adverse events at 3, 6, 9 and 12 months post-randomisation
    - DLCO at 3, 6 and 12 months post-randomisation where possible
    - laboratory assessed FVC and FEV1 at 3, 6 and 12 months where possible
    - sleep quality and reflux characteristics at 3 and 12 months post-randomisation
    - participant acceptability, risk of sleep apnoea, progression free survival, hospital free survival and respiratory related hospital free survival at 12 months post-randomisation
    - decline and rate of decline of absolute %FVC weekly over the course of 12 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned37
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA37
    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
    The end of the trial is defined as 4 months following the last follow-up visit of the last patient randomised to allow for data entry and data cleaning activities to be completed.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    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 months6
    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. of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F. of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F. of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F. of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F. of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F. of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 179
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 119
    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 state298
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 298
    F.4.2.2In the whole clinical trial 298
    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)
    There is no provision for continuing trial treatment at the end of the trial. PIs will be informed of the treatment allocation for participants randomised at their site. As lansoprazole is available on prescription the usual care teams will therefore be able to prescribe it if they wish.

    The results of this study will be published in a peer reviewed journal to allow consideration during guideline review for IPF.
    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 Decision2020-06-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-06-02
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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