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    Summary
    EudraCT Number:2017-001570-42
    Sponsor's Protocol Code Number:AirGOs-2
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-04-19
    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 ConcernedFinland - Fimea
    A.2EudraCT number2017-001570-42
    A.3Full title of the trial
    Aggravated airway inflammation: research on genomics and optimal treatments (AirGOs)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Aggravated airway inflammation: research on genomics and optimal treatments (AirGOs)
    A.3.2Name or abbreviated title of the trial where available
    AirGOs
    A.4.1Sponsor's protocol code numberAirGOs-2
    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 SponsorHelsinki University Hospital
    B.1.3.4CountryFinland
    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 supportHesinki University Hospital, competitive research fund
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki University Hospital
    B.5.2Functional name of contact pointSkin and Allergy Hospital
    B.5.3 Address:
    B.5.3.1Street AddressMeilahdentie 2
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00029 HUS
    B.5.3.4CountryFinland
    B.5.4Telephone number358505431421
    B.5.5Fax number358947186474
    B.5.6E-mailsanna.salmi@helsinki.fi
    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 Primaspan
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Acetylsalicylic acid (ASA-) exacerbated respiratory disease (AERD).
    E.1.1.1Medical condition in easily understood language
    Severe chronic rhinosinusitis with nasal polyps.
    Asthma
    E.1.1.2Therapeutic area Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
    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 is a randomized controlled multicenter study that focuses on severe CRSwNP and asthma in AERD patients. Our specific research questions are:
    Does ASA desensitization reduce polyp size, symptoms, revision-rate, exacerbation-rate, costs and improve lung function more effectively than placebo? Can we discover clinical or biological markers predictive for the beneficial effect of AD?
    E.2.2Secondary objectives of the trial
    Does ASA desensitization reduce polyp size, symptoms, revision-rate, exacerbation-rate, costs and improve lung function more effectively than placebo?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A total of 150 adult AERD patients with uncontrolled CRSwNP will be recruited in the Clinical Trial -part. This is a randomized double-blinded controlled trial with two intervention treatments. About 20% of participants of the Operative part, with uncontrolled AERD, will be recruited to participate the Clinical Trial -part. The patients undergo similar prior examinations as the patients participating The Operative part. Those negative to ASA-challenge test will not enter the Clinical Trial -part. All patients entering the Clinical Trial –part, have undergone earlier ethmoidal surgery (partial/total) and have not gained disease control. F-helicobacter antigen is tested and treatment is given if indicated. Both groups will undergo removal of polyps 4-6 weeks before start of trial medication.

    Inclusion criteria: Uncontrolled CRS according to EPOS 2012 criteria, endoscopic NP score ≥4 or SNOT22 ≥ 30, CT LM score total ≥ 12. Polypectomy is scheduled 1-2 months before start of ASA desensitization.
    E.4Principal exclusion criteria
    Exclusion criteria: Age <18 years, age > 65 years, complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis), previous sinus surgery except medial anthrostomy and opening of bulla, bleeding diathesis, pregnancy/ breastfeeding, cystic fibrosis, primary ciliary dyskinesia (PCD), sarcoidosis, granulomatosis with polyangitis (GPA), eosinophilic granulomatosis with polyangitis (EGPA), immunosuppression (diagnosed SAD, CVI, HIV or use of biologicals/immunosuppressive medication), immunotherapy, Daily use of systemic corticosteroids (Prednisolon at least 10mg per day or equivalent), communication problems (f.e. neurological/psychiatric disease, language skills), unlikely to comply, other severe disease, uncontrolled asthma, ASA-challenge negative, gastric ulcer, anticoagulant treatment, SSRI-depression medication, beta-blocker or severe chronic urticaria.
    E.5 End points
    E.5.1Primary end point(s)
    Primary end points are change in nasal endoscopic polyp score, SNOT-22, and lung function tests 11 and 12 months post-starting with the treatment. Secondary end points include changes in hrQOL, acoustic rhinometry (ARM), peak nasal inspiratory flow (PNIF), olfaction test (Sniffin’ Sticks, identification and threshold), pathologic findings, safety and costs. The patient will know the treatment arm at 12 months post-starting with the treatment) and can discuss with the doctor of the need to continue or start with ASA-desensitization or another treatment, if needed.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end points are change in nasal endoscopic polyp score, SNOT-22, and lung function tests 11 and 12 months post-starting with the treatment.
    E.5.2Secondary end point(s)
    Follow-ups. The visits are before treatment and follow-up visits are once per month at the same time with the injection. The symptom questionnaire and interview of side-effects are performed during each visit. Lung function (eNO, nNO, PEF, spirometry) is monitored and the patient will visit doctor and/or nurse at 1, 5, 11, and 12 months post-starting with the treatment. Samples are taken before and after challenge and at 11 months post-starting with the treatment. We also monitor side-effects, exacerbations, need of medication (po. cortisocteroids; antibiotics) and satisfaction to treatment.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points include changes in hrQOL, acoustic rhinometry (ARM), peak nasal inspiratory flow (PNIF), olfaction test (Sniffin’ Sticks, identification and threshold), pathologic findings, safety and costs. The patient will know the treatment arm at 12 months post-starting with the treatment) and can discuss with the doctor of the need to continue or start with ASA-desensitization or another treatment, if needed.
    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 Yes
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 last visit of the last subject undergoing the trial.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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) No
    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 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 state125
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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)
    Patient´s disease control is monitored before- during and post-trial in the hospital by ENT-doctor and pulmonologist and treated adequately. In uncontrolled disease the need for sinus surgery is also evaluated. If willing, participants can re-start using ASA desensitization after the clinical trial. In uncontrolled disease the need for sinus surgery is also evaluated.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation University of Helsinki
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-02-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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