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    Summary
    EudraCT Number:2019-003254-91
    Sponsor's Protocol Code Number:AGO/2019/005
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-07-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-003254-91
    A.3Full title of the trial
    Characterisation and intervention study in patients with long-term use of nasal decongestants.
    Karakterisatie- en interventiestudie bij patiënten met langdurig gebruik van nasale decongestiva.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Research on underlying causes of long-term use of nasal decongestant spray or drops and the structured withdrawal of the decongestant spray or drops.
    Onderzoek naar onderliggende redenen van langdurig gebruik van ontzwellende neussprays/druppels en de begeleide afbouw van ontzwellende neussprays/druppels.
    A.4.1Sponsor's protocol code numberAGO/2019/005
    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 SponsorGhent University Hospital
    B.1.3.4CountryBelgium
    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 supportGhent University Hospital
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGhent University Hospital
    B.5.2Functional name of contact pointHIRUZ
    B.5.3 Address:
    B.5.3.1Street AddressCorneel Heymanslaan 10
    B.5.3.2Town/ cityGhent
    B.5.3.3Post code9000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+329332 05 00
    B.5.5Fax number+329332 05 20
    B.5.6E-mailhiruz.ctu@uzgent.be
    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.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameMometasone
    D.3.4Pharmaceutical form Nasal spray, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMometasone furoate
    D.3.9.3Other descriptive nameMometasone furoate
    D.3.9.4EV Substance CodeSUB03318MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    rhinitis medicamentosa
    E.1.1.1Medical condition in easily understood language
    non-allergic drug-induced disease of the nose
    niet-allergische geneesmiddel-geïnduceerde aandoening van de neus
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    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
    Primary objective: To evaluate the effectiveness (success rate) of a standardized, structured withdrawal plan based on Mometasone combined with motivational interviewing to reduce overuse of nasal decongestants.

    Co-primary objective: To evaluate the relapse rates of patients with former nasal decongestant overuse.
    E.2.2Secondary objectives of the trial
    Secondary objectives:
    - To evaluate the change in rhinitis control due to the withdrawal of the nasal decongestant;
    - To evaluate the change in nasal patency due to the withdrawal of the nasal decongestant;
    - To evaluate the change in disease specific health-related quality of life (HRQoL) due to the withdrawal of the nasal decongestant;
    - To evaluate the change in Sleep disturbance due to the withdrawal of the nasal decongestant;
    - To evaluate the change in nasal endoscopy outcomes due to the withdrawal of the nasal decongestant.

    Secondary exploratory objective: To assess the effect of withdrawal on exploratory biomarkers of inflammation and immune response in blood samples and nasal secretions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Part A: healthy volunteers
    1. Aged 18 years or older
    2. Sufficient knowledge of the Dutch language

    Part A and B: participants with overuse of nasal decongestants
    1. Aged 18 years or older
    2. Daily use of nasal decongestant for at least 6 months
    3. Sufficient knowledge of the Dutch language
    E.4Principal exclusion criteria
    Part A: healthy volunteers
    1. Subjective presence of nasal disease (i.e. the study subject indicates to experience any nasal symptoms, an occasional common cold not taken into account)
    2. Established diagnosis of a nasal disorder (e.g. allergy, nasal polyps, …) or a positive allergy test (skin prick test or blood test)
    3. Prior nasal surgery
    4. Asthma
    5. Use of an oral corticosteroid in the month prior to the screening visit (T-2)
    6. Significant disease(s) that might interfere with the study, based on the judgement of the investigator.
    7. Current use of a nasal decongestant, more than two episodes of 7 days use of a nasal decongestant in the previous year or less than two episodes of 7 days use (in the previous year) but last use less than a month prior to the screening visit (T-2)
    8. Other medication used to treat nasal symptoms (intranasal corticosteroids, oral or intranasal antihistamines, oral decongestants…)
    9. History of rhinitis medicamentosa (either patient-reported long-term use of a nasal decongestant or a diagnosis of rhinitis medicamentosa)
    10. Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding

    Part A: participants with overuse of nasal decongestants
    1. Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
    2. Use of an oral corticosteroid in the month prior to the screening visit (T-2)
    3. Use of an oral decongestant in the week prior to the screening visit (T-2)
    4. Significant disease(s) that might interfere with the study, based on the judgement of the investigator

    Part B: participants with overuse of nasal decongestants
    1. Pregnancy, trying to become pregnant (during the duration of the study) or breastfeeding
    2. Glaucoma
    3. Use of an oral corticosteroid in the month prior to the start of the intervention (T1)
    4. Use of an oral decongestant in the week prior to the start of the intervention (T1)
    5. Significant disease(s) that might interfere with the study, based on the judgement of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Primary end point: Proportion of study subjects with overuse of nasal decongestants able to completely withdraw the use of the nasal decongestant.

    Co-primary end point: Proportion of study subjects who were able to completely withdraw the overuse of nasal decongestants at the follow-up 2 (T3, after 12 weeks of intervention) who relapsed by the time of follow-up 3 (T4).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end point: Follow-up 2 (T3, after 12 weeks of intervention).

    Co-primary end point: Telephone follow-up (= follow-up 3) (T4, 6 months after the start-up of the intervention).
    E.5.2Secondary end point(s)
    Secondary end points:
    - Change from intervention baseline (T1) in Rhinitis Control Assessment Test (RCAT) score;
    - Change from intervention baseline (T1) in home measured Peak Nasal Inspiratory Flow (PNIF) as captured in the daily diary on a fixed day every week / Change from intervention baseline (T1) in hospital measured PNIF / Change from intervention baseline (T1) in visual analogue scale (VAS) for nasal obstruction / Change from intervention baseline (T1) in nasal symptom score(s) as captured in the daily diary;
    - Change from intervention baseline (T1) in Mini Rhinoconjunctivitis Quality of Life Questionnaire (miniRQLQ);
    - Change from intervention baseline (T1) in PROMIS Sleep Disturbance short form 8b;
    - Change in nasal endoscopy outcomes.

    Secondary exploratory end point : Change from baseline (T0) in exploratory biomarkers of inflammation and immune response in blood samples and nasal secretions.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end points:
    - Intervention baseline (T1), follow-up 1 (T2, after 6 weeks of intervention) and follow-up 2 (T3, after 12 weeks of intervention);
    - Weekly measurements during: Screening period (2 weeks) and Intervention period (12 weeks) / Intervention baseline (T1), follow-up 1 (T2) and follow-up 2 (T3) / Ditto / Daily recordings of VAS score during: Screening period (2 weeks) and Intervention period (12 weeks);
    - Intervention baseline (T1), follow-up 1 (T2) and follow-up 2 (T3);
    - Ditto;
    - Baseline (T0, characterisation study) and follow-up 2 (T3, after 12 weeks of intervention).

    Secondary exploratory end point: Baseline (T0 characterisation study) and follow-up 2 (T3, after 12 weeks of intervention).
    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) 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 years3
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2020-07-28. Yes
    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 state135
    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 (standard of care)
    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 Decision2020-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-18
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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