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    Summary
    EudraCT Number:2014-004058-32
    Sponsor's Protocol Code Number:2014RESP02M(14-01-14)
    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:2015-06-12
    Trial 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 number2014-004058-32
    A.3Full title of the trial
    The Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary Fibrosis with the Addition of Co-trimoxazole (EME-TIPAC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treating pulmonary fibrosis with co-trimoxazole
    A.3.2Name or abbreviated title of the trial where available
    Treating pulmonary fibrosis with co-trimoxazole
    A.4.1Sponsor's protocol code number2014RESP02M(14-01-14)
    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 Hospital NHS Foundation Trust
    B.1.3.4Country
    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
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNorfolk and Norwich University Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointLisa Chalkley
    B.5.3 Address:
    B.5.3.1Street AddressResearch Services Manager, R&D Department,Norfolk and Norwich University Hosp
    B.5.3.2Town/ cityNorwich
    B.5.3.3Post codeNR4 7UY
    B.5.4Telephone number01603 286611
    B.5.5Fax number01603 289800
    B.5.6E-maillisa.chalkley@nnuh.nhs.uk
    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 Cotrimoxazole
    D.2.1.1.2Name of the Marketing Authorisation holderChemidex Pharma limited trading as Essential Generics
    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 nameCotrimoxazole
    D.3.2Product code NA
    D.3.4Pharmaceutical form Tablet
    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 INNtrimethoprim
    D.3.9.1CAS number 738-70-5
    D.3.9.2Current sponsor codenone
    D.3.9.3Other descriptive namenone
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNsulphamethoxazole
    D.3.9.1CAS number 723-46-6
    D.3.9.2Current sponsor codenone
    D.3.9.3Other descriptive namenone
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 placeboTablet
    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 18.0
    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
    Does co-trimoxazole change the life expectancy and/or reduce the chances of being admitted to hospital or having a lung transplant for people with pulmonary fibrosis.
    E.2.2Secondary objectives of the trial
    Does co-trimoxazole change how patients feel about their quality of life or their breathlessness and/or cough, their oxygen levels, breathing tests or blood biomarkers. Fifty patients will undergo a lung camera test (bronchoscopy) to obtain lung fluid samples to find out whether co-trimoxazole changes the numbers or amount of inflammatory cells, biomarkers and bacteria (using traditional and new techniques). The biomarkers will tell us about inflammation, lung damage and scar production. An additional objective is to find out whether the changes in inflammatory cells' biomarkers or bugs relate to the changes in clinical outcomes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female, aged greater than or equal to 40 years. IPF rarely occurs in individuals less than 40 years. Individuals younger than this more frequently have connective tissue related lung disease which is similar to but different from IPF.
    2) A diagnosis of idiopathic pulmonary fibrosis (IPF) based on multi-disciplinary consensus according to the latest international guidelines within 2 years of enrolment into the study. Patients with a diagnosis of more than 2 years duration can be enrolled if they have evidence of progressive disease defined as ≥10% decline in forced vital capacity (FVC) or ≥15% decline in diffusing capacity of carbon monoxide over the preceding 6 or 12 months.
    3) Patients may receive oral prednisolone up to a dose of 10 mg per day, anti-oxidant therapy, pirfenidone or other licensed medication for IPF e.g. nintedanib. Patients should be on a stable treatment regimen for at least 6 weeks to ensure baseline values are representative.
    4) MRC dyspnoea score of greater than 1.
    5) Able to provide informed consent.
    E.4Principal exclusion criteria
    1) FVC > 70% predicted.
    2) A recognised significant co-existing respiratory disease, defined as a respiratory condition that exhibits a greater clinical effect on respiratory symptoms and disease progression than IPF as determined by the principal investigator.
    3) Patients with airways disease defined as forced expiratory volume in 1 second (FEV1)/FVC<60%
    4) A self-reported respiratory tract infection within 4 weeks of screening defined as two or more of cough, sputum or breathlessness and requiring antimicrobial therapy.
    5) Significant medical, surgical or psychiatric disease that in the opinion of the patient’s attending physician would affect subject safety or influence the study outcome including liver (Serum transaminase > 3 x upper limit of normal (ULN), Bilirubin > 2 x ULN) and renal failure (creatinine clearance <30ml/min).
    6) Patients receiving recognised immunosuppressant medication (except prednisolone above) including azathioprine and mycophenolate mofetil.
    7) Female subjects must be of non-childbearing potential, defined as follows: postmenopausal females who have had at least 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhoea with serum FSH>40mIU/ml or females who have had a hysterectomy or bilateral oophorectomy at least 6 weeks prior to enrolment.
    8) Allergy or intolerance to trimethoprim or sulphonamides or their combination.
    9) Untreated folate or B12 deficiency.
    10) Known glucose-6-phosphate dehydrogenase (G6PD) deficiency or G6PD deficiency measured at screening in males of African, Asian or Mediterranean descent.
    11) Receipt of an investigational drug or biological agent within the 4 weeks prior to study entry or 5 times the half-life if longer.
    E.5 End points
    E.5.1Primary end point(s)
    The time to death (all causes), lung transplant or the first non-elective hospital admission.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomisation of first patient until 12 months after the last patient is randomised, follow up is at 6 weeks, 3 months, 6 months, 9 months 12 months and then every 6 months.
    E.5.2Secondary end point(s)
    Secondary efficacy outcomes
    • Time from randomisation to death (all causes)
    • Time from randomisation to first non-elective hospital admission for any reason
    • Health related quality of life: (i)the King’s Brief Interstitial Lung Disease (K-BILD) health related quality of life questionnaire; (ii) the MRC Breathlessness Score; (iii) the EQ5D quality adjusted life year’s assessment, (iv) cough score
    Lung function including assessment by spirometry and total lung diffusing capacity of carbon monoxide (DLCO)
    Secondary outcome measures for safety
    • Full blood count
    • Urea and electrolytes
    • Liver function
    • Adverse Events including SAEs
    Further exploratory and mechanistic outcomes
    From the stored blood the proposed analyses, which is subject to change depending on the results of the bronchoscopy results.
    • CRP as a measure of infection/inflammation;
    • SP-D as a markers of epithelial injury;
    • MMP-7 as a marker of disease severity;
    • Neutrophil count
    E.5.2.1Timepoint(s) of evaluation of this end point
    From randomisation of first patient until 12 months after the last patient is randomised, follow up is at 6 weeks, 3 months, 6 months, 9 months 12 months and then every 6 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 No
    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) 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 concerned28
    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
    12 months after the LVLS to enable data cleaning activities to be completed in all sites
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 130
    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 state330
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 330
    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)
    Co-trimoxazole is not currently used to treat patients with pulmonary fibrosis and there is no provision for continuing the treatment at the end of the study. However, if we find participants who have been taking co-trimoxazole have had a noticeable benefit from it, we will be able to tell their doctor.
    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 Decision2014-12-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-30
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