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    Summary
    EudraCT Number:2021-000190-81
    Sponsor's Protocol Code Number:TIPP
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2021-09-21
    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 number2021-000190-81
    A.3Full title of the trial
    A prospective multicenter placebo-controlled trial to study the efficacy and safety of Tiotropium in preventing severe asthma exacerbations in partial and uncontrolled preschool asthma. TIPP-Study
    Eine prospektive, placebokontrollierte multizentrische Studie zur Untersuchung der Wirksamkeit und Sicherheit von Tiotropium bei der Vorbeugung von schweren Asthma-Exazerbationen bei teil- und unkontrolliertem Asthma im Vorschulalter. TIPP Studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tiotropium in preventing preschool asthma (TIPP)
    Tiotropium zur Vorbeugung von Asthma bei Vorschulkindern
    A.3.2Name or abbreviated title of the trial where available
    TIPP
    TIPP
    A.4.1Sponsor's protocol code numberTIPP
    A.5.4Other Identifiers
    Name:Boehringer IngelheimNumber:Trial-Number: 0205-0546
    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 SponsorGoethe-University Frankfurt
    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 supportFederal Ministry for Education and Research (BMBF)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportBoehringer Ingelheim
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGoethe University Frankfurt, Department for Children and Adolescents
    B.5.2Functional name of contact pointProf. Dr. med. Stefan Zielen
    B.5.3 Address:
    B.5.3.1Street AddressTheodor-Stern-Kai 7
    B.5.3.2Town/ cityFrankfurt a.M.
    B.5.3.3Post code60590
    B.5.3.4CountryGermany
    B.5.4Telephone number+4969630183063
    B.5.5Fax number+4969630183349
    B.5.6E-mailStefan.Zielen@kgu.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 nametiotropium bromide inhalation solution
    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 INNTiotropium bromide
    D.3.9.1CAS number 411207-31-3
    D.3.9.3Other descriptive nameTIOTROPIUM BROMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21897
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 Yes
    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
    Severe asthma exacerbations in partial and uncontrolled preschool asthma
    Schweres Asthma-Exazerbationen bei teil- und unkontrolliertem Asthma im Vorschulalter
    E.1.1.1Medical condition in easily understood language
    Severe preschool asthma
    Schweres Asthma im Vorschulalter
    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
    The primary objective is to evaluate whether addition of Tiotropium via Respimat® to ICS prevents severe asthma exacerbations.
    Das primäre Ziel ist herauszufinden, ob die Zugabe von Tiotropium zu inhalativen Kortikosteroiden schwere Exazerbationen verhindert.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate whether addition of Tiotropium via Respimat® to ICS reduces health utilization (hospitalizations, physician visits, antibiotic use) in partial or uncontrolled preschool asthma.
    Untersuchung, ob die Zugabe von Tiotropium zu inhalativen Kortikosteroiden (ICS) die Inanspruchnahme von Gesundheitsleistungen (Krankenhausaufenthalte, Arztbesuche, Antibiotikaeinsatz) bei teil- oder unkontrolliertem Asthma im Vorschulalter verringert.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients with preschool asthma aged between 1 and 5 years (< 6 at visit 1). In addition, age-appropriate assent in accordance with local regulations or guidelines or both before enrolment in the study and prior to the beginning of any study-specific procedures will be obtained from the child.
    2. Physician diagnosed asthma of at least 6 months’ history of asthma symptoms, including (but not limited to) wheezing, cough, and/or shortness of breath.
    3. All patients must have been on maintenance treatment with an ICS at a stable dose, either as mono treatment or in combination with another controller medication, for at least 4 weeks before visit 1.
    4. Patient was hospitalized due to acute severe asthma and/or was treated with at least 2 courses of systemic steroids (three days of oral steroids or one day of rectal prednisolone 100mg (Rectodelt®)) in the last 24 months before visit 1.
    5. All patients must be symptomatic (partly controlled or uncontrolled) as defined by the GINA guideline for children aged 5 years and younger in the four weeks prior to screening (visit 1) and randomization (visit 2) despite treatment with ICS (visit 1 and visit 2).
    6. Patients must be able to inhale from the Respimat® inhaler (with a spacer).
    1. Männliche oder weibliche Patienten mit Asthma im Vorschulalter (Alter zwischen 1 und 5 Jahren; < 6 bei Visite 1). Sofern möglich wird zusätzlich eine altersgemäße Zustimmung des Kindes zur Studienteilnahme vom Prüfarzt eingeholt.
    2. Vom Arzt diagnostiziertes Asthma mit mindestens 6-monatiger Vorgeschichte von Asthma-Symptomen, einschließlich (aber nicht beschränkt auf) Keuchen, Husten und/oder Kurzatmigkeit.
    3. Alle Patienten müssen bereits eine Erhaltungstherapie mit einem ICS in einer stabilen Dosis - entweder als Monotherapie oder in Kombination mit einem anderen Medikament - mindestens 4 Wochen lang vor Visite 1 erhalten haben.
    4. Der Patient wurde aufgrund von akutem schwerem Asthma in den letzten 24 Monaten hospitalisiert und/oder in den letzten 24 Monaten vor Visite 1 mit mindestens zwei Behandlungen systemischer Steroide (3 Tage orale Steroide oder ein Tag Prednisolon rektal 100 mg (Rectodelt®)) therapiert.
    5. Alle Patienten müssen in den vier Wochen vor dem Screening und vor der Randomisierung (Visite 1 bzw. Visite 2) trotz ICS- Behandlung symptomatisch (teilweise oder unkontrolliert) im Sinne der GINA-Leitlinie für Kinder ab 5 Jahren sein.
    6. Die Patienten müssen in der Lage sein, aus dem Respimat® -Inhalator zu inhalieren (mit einem Spacer).
    E.4Principal exclusion criteria
    1. Patients with a significant disease other than asthma such as, but not limited to, the following diagnoses: cystic fibrosis, bronchopulmonary dysplasia, primary immunodeficiency, congenital heart disease, parasitic disease, and foreign body aspiration.
    2. Patients with clinically relevant abnormal screening hematology or blood chemistry will be excluded if the abnormality defines a significant disease as defined in exclusion criterion.
    3. Patients with known hypersensitivity to anticholinergic drugs, or any other components of the Tiotropium inhalation solution.
    4. Patients with any severe acute asthma exacerbation or severe respiratory tract infection defined by systemic steroid intake or
    hospitalization in the four weeks prior to visit 1.
    1. Patienten mit einer anderen signifikanten Erkrankung als Asthma, wie zum Beispiel - aber nicht beschränkt auf - Mukoviszidose, bronchopulmonale Dysplasie primäre
    Immundefizienz, angeborene Herzerkrankung, parasitäre Erkrankungen und Fremdkörperaspiration.
    2. Patienten mit klinisch relevanten Anomalien in der Screening-Hämatologie oder klinische Chemie werden ausgeschlossen, wenn die Anomalie eine signifikante Krankheit im Sinne des Ausschlusskriteriums darstellt.
    3. Patienten mit bekannter Überempfindlichkeit gegen Anticholinergika oder andere Bestandteile der Tiotropium-Inhalationslösung.
    4. Patienten mit einer schweren akuten Asthmaexazerbation oder schweren Atemwegsinfektion (definiert durch die Gabe systemsicher Steroide oder Hospitalisierung) in den vier Wochen vor Visite 1.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first severe exacerbations, defined by hospitalization and/or at least 3 days of systemic steroids or one day of rectal prednisolone (Rectodelt®).
    Zeit bis zur ersten schweren Exazerbation, definiert durch Hospitalisierung und/oder 3 Tage Gabe systemischer Steroide oder 1 Tag Prednisolon rektal (Rectodelt®).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint to first severe exacerbations
    Zeitpunkt der ersten schweren Exazerbation
    E.5.2Secondary end point(s)
    Number of severe exacerbations, number of hospitalizations (severe exacerbation), (severe) exacerbation-free survival time, number of asthma-related events defined by use of antibiotics, percentage of night-time awakenings due to asthma symptoms as assessed by the electronic patient`s diary/PACD, percentage of days without asthma symptoms assessed by TIPP diary App (PACD), percentage of days and episodes of > 3 days with use of PRN salbutamol rescue medication, health utilization (number of physician visits), number of missed days in daycare, result of TRACK, CGI-C at end of treatment and potential biomarkers for treatment response: Eosinophils, IgE, specific IgE to common allergens (birch, grass, Dermatophagoides pteronyssinus, Dermatophagoides farina, Alternaria, Cladosporium, cat, dog, hen's egg, cow's milk and peanut.
    Assessment of safety: Safety will be ensured by analysis of symptom scores and rescue medication use by the electronic diary, and adverse events (AEs).
    Anzahl der schweren Exazerbationen; Anzahl der Krankenhausaufenthalte (schwere Exazerbation); Zeitraum ohne Exazerbationen; Anzahl der asthmabezogenen Ereignisse, definiert durch den Einsatz von Antibiotika; nächtliches Erwachen aufgrund von Asthma-symptomen, bewertet anhand des elektronischen Patiententagebuchs/PACD; prozentualer Anteil der Tage ohne Asthmasymptome bewertet anhand des elektronischen Patiententagebuchs/PACD; prozentualer Anteil der Tage und Anzahl der Episoden (> 3 Tage) mit Einsatz von Salbutamol als Notfallmedikation; Anzahl der Arztbesuche, Anzahl Fehltage in der Kita, Ergebnis des TRACK-Tests, CGI-C am Behandlungsende und potenzielle Biomarker für das Ansprechen auf die Behandlung: Eosinophile, IgE, spezifisches IgE gegen häufige Allergene (Birke, Gras, Dermatophagoides pteronyssinus, Dermatophagoides farina, Alternaria, Cladosporium, Katze, Hund, Hühnerei, Kuhmilch und Erdnuss.
    Bewertung der Sicherheit: Die Sicherheit wird durch die Analyse der Symptomwerte und der Verwendung von Notfallmedikamenten anhand des elektronischen Tagebuchs sowie durch unerwünschte Ereignisse (AEs) gewährleistet.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 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 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) 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 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 Yes
    E.8.1.7.1Other trial design description
    prospective, multicenter
    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 concerned14
    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 (after visit 7)
    Letzte Visite des letzten Patienten (nach Visite 7)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    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 Yes
    F.1.1Number of subjects for this age range: 204
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 54
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 150
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    patients aged between 1 and 5 years are included in the study
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state204
    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 the end of the trial, patients will be treated according to well-accepted national and international recommendations and guidelines.
    Nach Abschluss der klinischen Prüfung werden die Patienten gemäß den anerkannten nationalen und internationalen Empfehlungen und Leitlinien behandelt.
    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 Decision2021-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-28
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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