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    Summary
    EudraCT Number:2017-000664-14
    Sponsor's Protocol Code Number:16178SE-AS
    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:2017-10-20
    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 number2017-000664-14
    A.3Full title of the trial
    A 2x2 factorial randomised examiner blind open label trial to determine the CLinical and cost- Effectiveness of hypertonic saline (HTS 6%) and carbocisteine for Airway cleaRance versus usual care over 52 weeks in bronchiectasis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the effect of two medications (hypertonic saline and carbocisteine) with routine care to help with clearing sputum in people with bronchiectasis
    A.3.2Name or abbreviated title of the trial where available
    The CLEAR Trial
    A.4.1Sponsor's protocol code number16178SE-AS
    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 SponsorBelfast Health and Social Care 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
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportPARI GMBH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQueens University Belfast
    B.5.2Functional name of contact pointProfessor Judy Bradley
    B.5.3 Address:
    B.5.3.1Street AddressNorthern Ireland Clinical Research Facility, 97 Lisburn Road
    B.5.3.2Town/ cityBelfast
    B.5.3.3Post codeBT9 7AB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02895047973
    B.5.6E-mailjudy.bradley@qub.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 Information not present in EudraCT
    D.2.1.1.1Trade name MucoClear® 6%
    D.2.1.1.2Name of the Marketing Authorisation holderPARI Pharma GmbH
    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 nameMucoClear® 6%
    D.3.4Pharmaceutical form Inhalation solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSodium Chloride
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Mucodyne
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma 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 nameCarbocisteine
    D.3.4Pharmaceutical form 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 INNS-carboxymethyl L-cysteine
    D.3.9.1CAS number 638-23-3
    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 number375
    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
    Bronchiectasis
    E.1.1.1Medical condition in easily understood language
    Bronchiectasis is a permanent widening and thickening of the airways. People with bronchiectasis suffer from a chronic cough, sputum production and frequenct chest infections.
    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
    This study aims to find out if hypertonic saline (salty water) or carbocisteine or a combination of both is most effective at reducing the number of exacerbations in people with bronchiectasis following 52 weeks of treatment.

    People with bronchiectasis have chronic sputum production and both hypertonic saline and carbocisteine can help people with bronchiectasis clear their chest. Research has shown that these agents can make it easier for patients to cough up sputum resulting in potentially fewer exacerbations requiring antibiotics and hospital admissions.
    E.2.2Secondary objectives of the trial
    This study aims to find out whether treatment with hypertonic saline or carbocisteine: (i) improves the health related quality of life for people with bronchiectasis; (ii) reduces time to next exacerbation; (iii) reduces the number of days of antibiotics related to exacerbations over 52 weeks; (iv) improves generic health related quality of life; v) are acceptable from a patient satisfaction perspective at 52 weeks; (vi) is associated with any adverse events; (vii) improves lung function over 52 weeks; The study also aims to find out which treatment is the most cost-effective; This study will also explore how often participants' take the hypertonic saline/carbocisteine in comparison to the prescribed amount over the 52 weeks.
    The Sub- Study aims to validate and measure the sensitivity of the definition for exacerbations in bronchiectasis.
    The Study within a Trial will look at recruitment and retention on the CLEAR clinical trial.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub- Study Title: Validity and sensitivity of the EMBARC definition for exacerbations in bronchiectasis: A sub-study within the CLEAR trial
    Protocol Version: 1.0 Final
    Protocol Date: 03/10/2017
    Objective: This study aims to validate and measure the sensitivity of the EMBARC definition for exacerbations in bronchiectasis. The study will compare the criteria in the EMBARC definition to the criteria of a modified Fuch’s definition for diagnosing pulmonary exacerbations in bronchiectasis patients.

    Study within a study Title: Optimising Recruitment and Retention: Implementing Studies Within A Trial (SWATs) with the CLEAR clinical trial
    Protocol Version: 1.0 Final
    Protocol Date:03/10/2017
    Objective: The aim of this project is to explore the effect of methods used to optimise recruitment and retention.
    E.3Principal inclusion criteria
    1. Diagnosis of bronchiectasis on high resolution computed tomography (HRCT)/computed tomography (CT) scans
    2. Bronchiectasis must be the primary respiratory diagnosis
    3. Two or more pulmonary exacerbations in the last year requiring antibiotics
    4. Production of daily sputum
    5. Stable for 14 or more days before the first study visit with no changes to treatment
    6. Willing to continue any other existing chronic medication throughout the study
    7. Female subjects must be either surgically sterile, postmenopausal or agree to use effective contraception during the treatment period of the trial
    E.4Principal exclusion criteria
    1. Age <18 years old
    2. Patients with cystic fibrosis (CF)
    3. Forced expiratory volume in one second (FEV1) <30%
    4. Treatment with HTS, carbocisteine or any mucolytics within the past 30 days
    5. If using long term macrolides, on them for one months before joining the study
    6. Active peptic ulceration
    7. Hypersensitivity to any of the active ingredients or the excipients of carbocisteine
    8. Women who are pregnant or lactating
    9. Participation in other trials of investigational products within 30 days
    10. Any heredity galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
    11. Patients unable to swallow oral capsules
    12. Patients on regular isotonic saline
    13. Known contraindication or intolerance to hypertonic saline or carbocisteine
    14. Patients with COPD as a primary respiratory diagnosis
    15. Current smokers, female ex-smokers with greater than 20 pack years and male ex-smokers with greater than 25 pack years
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for this study number of exacerbations over 52 weeks post randomisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 Weeks.
    E.5.2Secondary end point(s)
    i. Disease specific HRQoL (respiratory symptoms domain of QoL-B at 52 weeks
    ii. Time to next exacerbation post randomisation
    iii. Number of days of antibiotics related to exacerbations over 52 weeks
    iv. Generic HRQoL
    v. Health Service use over 52 weeks
    vi. QALY over 52 weeks
    vii. Measurement of health impairment using the SGRQ
    viii. Patient preferences for treatment
    ix. Adverse Events over 52 weeks
    x. Lung function over 52 weeks
    xi. Adherence to HTS and carbocisteine over 52 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 and 104 weeks.
    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 Yes
    E.6.13.1Other scope of the trial description
    Cost-Effectiveness
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Examiner blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Usual care
    E.8.2.4Number of treatment arms in the trial4
    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 concerned16
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    The end of trial will be when database lock occurs for the final study analysis
    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 months11
    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 months11
    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: 380
    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 state380
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 380
    F.4.2.2In the whole clinical trial 380
    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)
    Participants will be followed up for one year following the completion of the initial 52 week treatment period. At the end of the treatment period the local study team will review the options available to patient and instruct them on who they should arrange their future treatment with.
    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 Decision2017-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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