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    Summary
    EudraCT Number:2015-001736-38
    Sponsor's Protocol Code Number:Academed100215
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-09-18
    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 number2015-001736-38
    A.3Full title of the trial
    The utility of feNO in the differential diagnosis of chronic cough:
    The response to anti-inflammatory therapy with prednisolone and montelukast
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The utility of feNO in the differential diagnosis of chronic cough
    A.3.2Name or abbreviated title of the trial where available
    The utility of feNO in the differential diagnosis of chronic cough
    A.4.1Sponsor's protocol code numberAcademed100215
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02479074
    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 SponsorHull and East Yorkshire Hospitals NHS 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 supportAerocrine Limited
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHull and East Yorkshire Hospitals NHS trust
    B.5.2Functional name of contact pointMahboobeh Haji Sadeghi
    B.5.3 Address:
    B.5.3.1Street AddressRespiratory Medicine, , Castle Hill Hospital, Castle Rd, Cottingham, East Yorkshire
    B.5.3.2Town/ cityHull
    B.5.3.3Post codeHU16 5JQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01482 624009
    B.5.6E-mailMahboobeh.HajiSadeghi@hyms.ac.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 Montelukast
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz 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 nameMontelukast
    D.3.4Pharmaceutical form Film-coated 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 INNmontelukast sodium
    D.3.9.3Other descriptive namemontelukast
    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 number10
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Prednisolone
    D.2.1.1.2Name of the Marketing Authorisation holderActavis UK Limited
    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 namePrednisolone
    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 INNprednisolone
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic cough is a common and poorly diagnosed condition. Younger patients tend to receive a diagnosis of asthma, whereas older patients are increasingly identified has having gastroesophageal reflux disease. Those patients presenting with upper airway symptoms are frequently labelled as having rhinitis. A considerable proportion of patients elude a diagnosis, either through testing or by the use of therapeutic trials and are then labelled as idiopathic cough.
    E.1.1.1Medical condition in easily understood language
    Chronic cough is a common and poorly diagnosed condition. There are different causes of chronic cough the most common causes are asthma, postnasal drip and gastro-oesophageal reflux.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the difference in 24 hr cough counts measured using the Hull Automated Cough Counter (HACC), from baseline and after two weeks and four weeks treatment with either montelukast or prednisolone followed by montelukast in patients with FeNO≥30 ppb at screening or montelukast in patients with normal NO measurement of ≤20 ppb.

    E.2.2Secondary objectives of the trial
    Secondary end points: compare changes in patients cough reflex sensitivity using inhaled citric acid between high FeNO treatment groups and normal FeNO treatment group at baseline and after 2 weeks and 4 weeks treatment.
    Furthermore, to compare subjective measures of cough as demonstrated by Hull Airways Reflux Questionnaire (HARQ) and Leicester Cough Questionnaire before treatment and in second and fourth weeks of treatment between high FeNO treatment groups and normal FeNO treatment group.
    Evaluate changes in the sputum inflammatory cells to determine whether inflammatory markers present prior to therapy has an influence on the effectiveness of montelukast or prednisolone to treat chronic cough.
    Assess whether previous history of blood eosinophils may predict therapeutic response to anti-inflammatory medication in cough.
    At the end of the study we will look retrospectively at the Assess whether the efficiency of FeNO may help to predict therapeutic response to anti-inflammatory
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

    • Patients with a history of chronic cough (at least 8 weeks duration)
    • Male and female subjects of at least 18 yrs of age
    • Subjects able to understand the study and co-operate with the study procedures
    • Subjects who consent to their general practitioner (GP) being informed of their study participation.
    • Patients with a FeNO≥30ppb at presentation to the Chronic cough clinic.( required for entry on to the high FeNO treatment groups)
    • Patients with FeNO≤20 ppb at presentation to the chronic cough clinic (required for entry as a normal FeNO treatment group)
    E.4Principal exclusion criteria
    • Patients with current diagnosis of asthma.
    • Female subjects who are pregnant, or lactating, or who are of child bearing potential but are not using contraceptive measures
    • Suffering from any concomitant disease (chronic heart, chronic lung such as; COPD, bronchiectasis and cystic fibrosis, chronic renal, chronic liver or neuromuscular disease or immunosuppression; pneumonia and diabetes) which may interfere with study procedures or evaluation.
    • A lower respiratory tract infection 4 weeks prior to entry on to study
    • Systemic infections
    • Live virus immunisation planned within next 3 months
    • Subjects with no previous chickenpox who had a recent (<=28 days) close personal contact with chickenpox OR herpes zoster (high FeNO treatment groups only)
    • Subjects having recent (<=28 days) exposure to measles (high FeNO treatment groups only)
    • Participation in another study (use of investigational product) within 30 days preceding entry on to study.
    • Alcohol or drug abuse
    • Inability to follow study procedures
    • Regular use of corticosteroids either as inhaled, topical or systemic ≥ 4 weeks prior to enrolment
    . Subjects who are taking bronchodilators should be on it for at least 4 weeks on regular dose and carry on the same dose during the study
    • Subjects with known allergy to prednisolone
    • Subjects who are taking Angiotensin Converting Enzymes (ACE) inhibitors.
    • Current smoker
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is measure number of cough, as demonstrated by Hull Airways Cough counts at the baseline, after 2 and 4 weeks treatment; with either montelukast or prednisolone followed by montelukast in patients with FeNO≥30 ppb or montelukast in patients with normal NO measurement of ≤20 ppb between three treatment groups. Cough data will be normalised using log transformation this will allow us to use parametric test to analysis the data. ANCOVA test will be use to compare changes in the number of coughs.
    E.5.2Secondary end point(s)
    • Compare change in subjective measures on HARQ questionnaire and LCQ of cough between high FeNO treatment groups and normal FeNO treatment group at the baseline, after 14 days and 28 days treatment. Changes will be measured by using ANCOVA where p<0.05 will be significant.
    • Change in FVC % predicted from baseline will be expressed as mean (SD) and compared between the high FeNO treatment groups and normal FeNO treatment group at the baseline, after 14 days and 28 days treatment using ANCOVA.
    • Change in Sputum inflammatory cells – inflammatory cell total and differential counts (% neutrophils, eosinophils, macrophages, epithelial cells and lymphocytes) in sputum samples will be measured at baseline before treatment and after 14 days and 28 days treatment in all groups. Results will be expressed as mean (SEM). For non-parametric data these will be log transformed and expressed as geometric mean (log SEM). Changes in these parameters from baseline will be measured using ANCOVA where p<0.05 will be considered significant.
    • Change in cough reflex sensitivity using inhaled citric acid in treatment groups and control group high FeNO treatment groups and normal FeNO treatment group at the baseline and after 2 weeks and 4 weeks treatment. Changes will be measured by using ANCOVA where p<0.05 will be significant.
    • Assess whether the blood eosinophils may predict therapeutic response to anti-inflammatory medication in cough [5].
    • Assess whether the efficiency of FeNO will help to predict therapeutic response to anti inflammatory medication in cough.

    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 No
    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 years1
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days26
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days7
    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: 0
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 0
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    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)
    At the end of the study all patients will be reviewed by a chronic cough registrar/consultant as per the standard care as a clinic patient. In the judgment of the consultant and patient approval they may continue the therapy with montelukast.
    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 Decision2015-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-03-09
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