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    Summary
    EudraCT Number:2017-004219-37
    Sponsor's Protocol Code Number:P000554
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-07-29
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-004219-37
    A.3Full title of the trial
    A randomized, prospective, multicenter, controlled and double-blinded Phase II Clinical Trial to evaluate the influence of inhaled Aviptadil on Cough and Quality of Life in Sarcoidosis patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of Inhaled Aviptadil on Cough and Quality of life in Sarcoidosis
    A.3.2Name or abbreviated title of the trial where available
    Avisarco II
    A.4.1Sponsor's protocol code numberP000554
    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 SponsorUniversitätsklinikum Freiburg, Leitender Ärztlicher Direktor
    B.1.3.4CountryGermany
    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 supportDFG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Freiburg
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressKillianstr. 5
    B.5.3.2Town/ cityFreiburg i. Br.
    B.5.3.3Post code79106
    B.5.3.4CountryGermany
    B.5.6E-mailjoachim.mueller-quernheim@uniklinik-freiburg.de
    B.Sponsor: 2
    B.1.1Name of SponsorUniversitätsklinikum Freiburg, Kaufmännische Direktorin
    B.1.3.4CountryGermany
    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 supportDFG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Freiburg
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressKillianstr. 5
    B.5.3.2Town/ cityFreiburg i. Br.
    B.5.3.3Post code79106
    B.5.3.4CountryGermany
    B.5.6E-mailjoachim.mueller-quernheim@uniklinik-freiburg.de
    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 nameAviptadil
    D.3.4Pharmaceutical form Nebuliser 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 INNAviptadil
    D.3.9.1CAS number 40077-57-4
    D.3.9.2Current sponsor code4033410
    D.3.9.3Other descriptive nameAVIPTADIL
    D.3.9.4EV Substance CodeSUB05614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboInhalation solution
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pulmonary sarcoidosis associated with cough
    E.1.1.1Medical condition in easily understood language
    Pulmonary sarcoidosis associated with cough
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10037430
    E.1.2Term Pulmonary sarcoidosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess efficacy of Aviptadil in comparison to placebo on cough-specific QOL
    E.2.2Secondary objectives of the trial
    -To assess efficacy of Aviptadil in comparison to placebo on cough-specific QoL
    -To assess efficacy of Aviptadil in comparison to placebo on sarcoidosis specific QoL, on fatigue, on dyspnea on exertion, on patient’s assessment of cough intensity, on parameters of lung function.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To assess Transcription patterns
    E.3Principal inclusion criteria
    1. Adult male and female patients ≥ 18 years of age
    2. Patient with sarcoidosis and associated chronic cough (LCQ score < 16), any Scadding type, any other organ manifestation as long as it does not require prednisolone therapy > 15 mg, see exclusion criteria 3)
    3. Body mass index (BMI) <30 kg/m2
    4. Patients supposed to be kept on stable medication for the whole study period
    5. Written informed consent obtained according to international guidelines and local laws
    6. Negative results for HIV, hepatitis A, B and C within three months prior to study inclusion
    7. Ability to understand the nature of the trial and the trial related procedures in German and to comply with them
    8. Ability to use the nebulizer in a proper manner
    9. Ability to store the IMP according to requirements
    E.4Principal exclusion criteria
    1. Patients suffering from other organic causes of cough (e.g. respiratory tract infections, gastroesophageal reflux disease, heart failure, bronchitis associated with any other disorder but sarcoidosis, thoracic tumors, exposure to inhalable irritants, laryngitis etc)
    2. Patients treated with ACE-inhibitors or a history of ACE-inhibitor treatment within the last six weeks (ACE-inhibitors are also not allowed to start during the study)
    3. Corticosteroids doses > 15 mg prednisolone equivalent per day
    4. Immunosuppressive treatment (except for corticosteroids ≤ 15 mg prednisolone equivalent per day) within 3 months prior randomisation or indications to start or intensify immunosuppressive therapy during the study
    5. Patients suffering from other chronic or acute severe diseases besides sarcoidosis manifestations that might impair safe participation in the trial according to the treating physician, e.g.:
    - Chronic kidney disease (CKD) stage 4 and 5
    - Liver cirrhosis Child-Pugh score B and C
    - Intended surgery of heart, lung, liver or abdominal disease during the trial period
    - Active malignancies requiring chemo- and / or radiotherapy
    - Chronic bowel diseases not sufficiently controlled
    6. Conditions or medications supposed to influence the primary or secondary outcomes according to the local investigator’s appraisal (e.g. newly diagnosed obstructive sleep apnoea syndrome, newly or recently exacerbated psychiatric disease, modification of psychotic disease)
    7. Known HIV infection, infectious hepatitis (type A, B or C) or another currently uncontrolled infection
    8. Known hypersensitivity to the active substance or any of the excipients
    9. Participation in any other interventional clinical trial during this study or during the last 30 days prior to informed consent; simultaneous participation in registry and diagnostic trials is allowed
    10. Previous participation in this trial
    11. Known persistent abuse of medication, drugs or alcohol
    12. Relationship of dependence/employment with the sponsor or the investigator
    13. Current or planned pregnancy, nursing period or patients of reproductive potential who are not using effective birth control methods
    14. Male subjects with reproductive potential who refuse to use adequate means of contraception during and up to 90 days after stopping treatment with Aviptadil
    E.5 End points
    E.5.1Primary end point(s)
    Change in LCQ score from baseline until 24 weeks after randomisation
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks after randomisation
    E.5.2Secondary end point(s)
    - Change in LCQ score from baseline until 12 weeks after randomisation
    -Change in KSQ score from baseline to 12 and 24 weeks after randomisation
    - Fatigue assessment scale (FAS) week 12 and 24
    -Multidimensional fatigue inventory (MFI) week 12 and 24
    -Epworth Sleepiness Scale (ESS) week 12 and 24
    -Distance-saturation-product (DSP) week 12 and 24
    -VAS for cough week 12 and 24
    -Lung function parameters at 12 and 24 weeks after randomisation
    -Cumulative steroid dose up to 24 weeks
    -6-minute walking distance and distance saturation product at 12 and 24 weeks
    E.5.2.1Timepoint(s) of evaluation of this end point
    -week 12 after randomisation
    -week 12 and 24 after randomisation
    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 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.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 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 trial2
    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 concerned10
    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
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state200
    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)
    After end of the trial, the therapy of the sarcoidosis will be performed according to the German treatment guidelines
    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 Decision2021-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-26
    P. End of Trial
    P.End of Trial StatusOngoing
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