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    Summary
    EudraCT Number:2016-004463-39
    Sponsor's Protocol Code Number:221921
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-19
    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 ConcernedSweden - MPA
    A.2EudraCT number2016-004463-39
    A.3Full title of the trial
    Influence on cough and airway symptoms by oral capsaicin (capscium oleoresin ) – a phase II, randomised, placebo-controlled clinical study in patients with chronic idiopathic cough
    Inverkan på kronisk hosta av capsaicin från chiliextrakt i kapslar
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence on cough and airway symptoms by oral capsaicin (capscium oleoresin) – a phase II, randomised, placebo-controlled clinical study in patients with chronic idiopathic cough
    Inverkan på kronisk hosta av extrakt från chilifrukter (capsaicin)
    A.4.1Sponsor's protocol code number221921
    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 SponsorSahlgrenska University Hospital, Department of Internal Medicine/Respiratory Medicine and Allergology
    B.1.3.4CountrySweden
    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 supportSwedish Heart and Lung Foundation
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportThe Swedish Cancer and Allergy Fund
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportThe Swedish Asthma and Allergy Association Research Fund
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportVINNOVA
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportRegional FOU Västra Götaland
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportALF Västra Götaland
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska University Hospital, Department of Internal Medicine, respiratory Medicine and Allergology
    B.5.2Functional name of contact pointEva Millqvist
    B.5.3 Address:
    B.5.3.1Street AddressBruna Stråket 11A
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code41345
    B.5.3.4CountrySweden
    B.5.4Telephone number46708433819
    B.5.6E-maileva.millqvist@medfak.gu.se
    B.Sponsor: 2
    B.1.1Name of SponsorUniversity of Gothenburg
    B.1.3.4CountrySweden
    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 supportSwedish heart and lungfoundation
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportSwedish cancer- and allergy fund
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportSwedish asthma and association research fund
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportVinnova
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportRegional FoU Västra Götaland
    B.4.2CountrySweden
    B.4.1Name of organisation providing supportALF Västra Götaland
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska university hospital, Department of Internal Medicine, Respiratory Medicine and Allegology
    B.5.2Functional name of contact pointEva Millqvist
    B.5.3 Address:
    B.5.3.1Street AddressBruna stråket 11 A
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code1345
    B.5.3.4CountrySweden
    B.5.4Telephone number+46708433819
    B.5.6E-maileva.millqvist@medfak.gu.se
    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 No
    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 nameCapsicum oleoresin
    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 INNCapsicum oleoresin
    D.3.9.1CAS number 8023-77-6
    D.3.9.2Current sponsor codeevami2
    D.3.9.3Other descriptive nameCAPSAICIN
    D.3.9.4EV Substance CodeSUB13229MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Chronic idiopathic cough
    E.1.1.1Medical condition in easily understood language
    Troublesome longstanding refractory coughing (more than 2 months) where no evident medical explanation can be found
    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
    To establish whether an oral intake of capsicum oleoresin; capsaicinoids expressed as 0,4 mg capsaicin (C18H27N03; M, 305.4) (from chili extract) can desensitise the cough reflex and improve unexplained coughing.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Out-patients, men and women
    • Age 18-75 years
    • Non-smoker
    • At screening visit reporting daily, troublesome coughing and an easily evoked cough reflex since at least two months
    • A diagnosis of CIC, set by a trained specialised physician
    • Exceeding the cut off limit for the Swedish version of the Hull Airway Reflux Questionnaire (HARQ-S): (a total score of ≥13 points)

    E.4Principal exclusion criteria
    • Known or suspected chili allergy
    • Known or suspected Tartrazine allergy
    • Treatment the preceding month with any kind of chili medication or food supplement containing capsaicin or having a diet including chili in treatment purpose
    • Treatment the preceding month with angiotensin-converting-enzyme (ACE) inhibitors other medications the may influence cough and the cough reflex sensitivity
    • Treatment the preceding month with morphine or codeine
    • Treatment the preceding month with Gabepentin or Pregabalin
    • Treatment the preceding month with insulin
    • Pregnancy, breast-feeding, planned pregnancy during the study and fertile women not using acceptable contraceptive measures, as judged by the investigator
    • Suspected poor capability to follow instructions of the study, e.g. because of a history of drug abuse, difficult to read and/or understand Swedish or any other reason, as judged by the investigator
    • Airway infection the last 4 weeks before study start
    • Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or influence the results of the study, or the patient’s ability to participate in the study
    • Any clinically relevant abnormal findings in physical examination, vital signs at baseline visit, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study
    • Previous randomisation of treatment in the present study
    • Participation in another clinical study 30 days prior to and <luring this study
    • Smoking during the last ten years or/and >10 pack years
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variables will be C2log and C5log (logarithmic values of the inhaled capsaicin threshold concentration needed to reach two coughs (C2) and five coughs (C5) at the end of four weeks of treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 4 weeks treatment with either Capsicum oleoresin or placebo
    E.5.2Secondary end point(s)
    -Objectively measured cough counting (LCM) during 24 hours at four opportunities
    -Variables C10log (logarithmic values of the inhaled capsaicin threshold concentration needed to reach ten coughs (C10) after 4 weeks treatment
    -HARQ-S questionnaire after 2 and 4 weeks treatment
    -LCQ-S questionnaire after 2 and 4 weeks treatment
    -VAS-scale (0-100 mm) for 5 symptoms: coughing, rhinitis, difficulty breathing, throat irritation, stomach symptoms each day:
    Mean will be calculated for each of the four weeks of treatment.
    -VAS-scale (0-100 mm) for 5 symptoms: coughing, rhinitis, difficulty breathing, throat irritation, stomach symptoms, change from baseline to each of the four weeks of treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Objectively measured cough counting (LCM) during 24 hours at four opportunities: before and after treatment with either active substance or placebo
    -Variables C10log (logarithmic values of the inhaled capsaicin threshold concentration needed to reach ten coughs (C10) after 2 and 4 weeks treatment
    -HARQ-S questionnaire and LCQ-S questionnaire after 2 and 4 weeks treatment
    -VAS-scale (0-100 mm) for 5 symptoms: coughing, rhinitis, difficulty breathing, throat irritation, stomach symptoms each day:
    Mean will be calculated for each of the four weeks of treatment.
    -VAS-scale (0-100 mm) for 5 symptoms: coughing, rhinitis, difficulty breathing, throat irritation, stomach symptoms, change from baseline to each of the four weeks of treatment
    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 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) 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 No
    E.8.1.6Cross over Yes
    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 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 months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-29
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