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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-014036-37
    Sponsor's Protocol Code Number:AL0907ac
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-05-13
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-014036-37
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, controlado con placebo y doble ciego para evaluar la seguridad y la eficacia de una inmunoterapia específica con una preparación alergoide de ácaros del polvo Dermatophagoides pteronyssinus adsorbida en hidróxido de aluminio en pacientes con rinitis/rinoconjuntivitis con o sin asma bronquial alérgica.
    A.4.1Sponsor's protocol code numberAL0907ac
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAllergopharma Joachim Ganzer KG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameHouse dust mite allergoid (Dermatophagoides pteronyssinus)
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namehouse dust mite allergoid
    D.3.10 Strength
    D.3.10.1Concentration unit EID50/dose 50% Embryo Infective Dose/dose
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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.IMP: 2
    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 nameHouse dust mite allergoid (Dermatophagoides pteronyssinus)
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.3Other descriptive namehouse dust mite allergoid
    D.3.10 Strength
    D.3.10.1Concentration unit EID50/dose 50% Embryo Infective Dose/dose
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10000
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    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 placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSuspension for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Enfermedad alérgica mediada por la inmunoglobulina E (IgE) en adultos y adolescentes que manifiestan rinitis/rinoconjuntivitis alérgica con o sin asma bronquial alérgica controlada (Iniciativa global para el asma [GINA]) desencadenada por alérgenos de ácaros del polvo no eliminables.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10039085
    E.1.2Term Rhinitis allergic
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10001705
    E.1.2Term Allergic asthma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate efficacy and tolerability of specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of major allergens of Dermatophagoides pteronyssinus (D. pter.) in adolescents and adults with allergic rhinitis/rhinoconjunctivitis caused by house dust mites with or without controlled allergic asthma.

    The primary endpoint regarding efficacy is the change in the area under the curve (AUC) of the rhinitis symptom-medication-score (R-SMS) from the baseline period to after 2 years of double-blind treatment.
    E.2.2Secondary objectives of the trial
    - Change in the AUC of the R-SMS from the baseline season to the season after 1 year of double-blind treatment.
    - Immunologic changes: specific immunoglobuline G (IgG1 and IgG4).
    - Tolerability and safety of treatments during the entire trial period.
    - Well days based on rhinitis SMS (no medication intake and maximum 2 score points).
    - Response status in terms of 40% improvement for the primary efficacy variable for an individual trial subject.
    - Change of EQ-5D (before vs. after treatment).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has the subject given informed consent according to local requirements before any trial-related activities? (A trial-related activity is any procedure that would not have been performed during the routine management of the subject.)
    2. Is the subject a legally competent male or female outpatient?
    3. Is the subject aged 12 - 60 years?
    4. Does the subject suffer from IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without asthma (controlled, acc. to Global Initiative for Asthma [GINA] 2006) documented by:
    o SPT wheal for D. pter. ?5 mm in diameter and
    o Histamine (1% histamine) wheal ?3 mm and
    o NaCl control reaction <3 mm and
    o EAST result ?1.5 kU/L to D. pter. (central laboratory) and
    o Main discomfort in the months October to December or over the entire year on exposure to house dust mites and
    o Treated with anti-allergic medications for at least 2 years before enrolment.

    At the Beginning of the Treatment Period (March 2011):
    5. Does the subject have proven exposure to house dust mites demonstrated by positive house dust mite allergen determination in bed/upholstered furniture of the subject?s living area?
    6. Has the subject demonstrated adequate symptoms in the subject diary?
    E.4Principal exclusion criteria
    - Is the subject unable to understand and comply with the requirements of the trial?
    - Does the subject show a total IgE of >2000 kU/l?
    - Is the subject currently participating in any other trial or has the subject participated in any other trial within 30 days before inclusion in this trial?
    - Is/was the subject involved in the planning and conduct of the trial, an employee of Allergopharma Joachim Ganzer KG or of one of the trial sites or in any relationship of dependence with the sponsor and/or with the investigator?
    - Has the subject been previously enrolled or randomised to treatment in the present trial?
    - Is the subject mentally disabled or institutionalised due to an official or judicial order?
    - Does the subject have a positive pregnancy test before the baseline period?
    - Does the subject use an unacceptable and unreliable contraceptive method during the trial, is pregnant or within the lactation period or is seeking to become pregnant?
    - Has the subject undergone previous specific immunotherapy with allergens of house dust or storage mites in any formulation?
    - Is the subject currently undergoing any sort of immunotherapy?
    - Has the subject ever undergone specific immunotherapy with unknown allergen or an unsuccessful immunotherapy?
    - Has the subject undergone changes in sanitation actions against house dust mites in the previous 12 months before trial entry or planning changes during the trial?
    - Has the subject for storage mites like Acarus siro, Lepidoglyphus destructor or Tyrophagus putrescentiae:
    o Clinically relevant symptoms or
    o Sensitisation in the SPT: wheal diameter of respective interfering allergen ? wheal diameter of D. pter. or
    o Sensitisation to respective interfering allergen as determined by serum immunoassay ? kU/L value of D. pter.
    - Has the subject for other allergens than D. pter. that interfere with the annual diary periods from October to December:
    o Clinically relevant symptoms or
    o Sensitisation in the SPT: wheal diameter of respective interfering allergen ?3 mm or
    o Sensitisation to respective interfering allergen as determined by serum immunoassay >1.5 kU/L.
    Such other interfering allergens are especially of:
    ? Cat or dog,
    ? Moulds like Aspergillus or Penicillium,
    ? Blatella germanica,
    ? Parietaria and cypress family (only Spain and Italy)
    - Does the subject suffer from clinically relevant rhino-conjunctival or respiratory symptoms related to other reasons?
    - Has the subject a peak expiratory flow (PEF) or FEV1 <80% of predicted normal?
    - Has the subject uncontrolled or partly controlled asthma according to GINA guidelines?
    - Has the subject suffered from asthma for more than 10 years?
    - Has the subject suffered from rhinitis/rhinoconjunctival atopy symptoms for 20 years or longer?
    - Does the subject suffer from severe acute or chronic diseases, severe inflammatory diseases?
    - Does the subject suffer from autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies?
    - Does the subject suffer from severe psychiatric and psychological disorders including impairment of cooperation?
    - Does the subject suffer from recurrent seizures?
    - Does the subject suffer from irreversible secondary alterations of the reactive organ?
    - Has the subject any physiological and laboratory variables within/outside normal limits and reported to be greater than Grade 1 changes according to the Food and Drug Administration (FDA) Guidance for Industry and/or normal for population?
    - Is the subject treated with beta-blockers (locally and systemically)?
    - Has the subject any contraindication for use of adrenalin?
    - Has the subject completed or have an ongoing treatment with anti IgE antibody?
    - Has the subject ongoing long-term treatment with tranquilizers or other psychoactive drugs?
    - Is the subject treated for allergy according to severity of symptoms with other than the following medications during the assessment period: levocabastine nasal spray (0.5 mg/mL), loratadine/cetirizine tablets (10 mg), and oxymetazoline spray (0.05%)? (Unchanged basic treatment with inhaled corticosteroids up to a dose of 500 µg beclomethasone di propionate [BDP]/-equivalent and the use of salbutamol as needed is permitted in asthmatics.)
    - Is the subject using any prophylactic and any treatment with antiallergic medication in fixed (constant) dosage during the treatment phase of the trial?
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is the change in the area under the curve (AUC) of the Rhinitis Symptom-Medication-Score (R-SMS) from the baseline period to after 2 years of double-blind 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 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 Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 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.8.3 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 EEA49
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    End of open-label treatment period
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) Yes
    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 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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 690
    F.4.2.2In the whole clinical trial 900
    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)
    Patients will be followed up according to GCP-, ICH- and WHO-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 Decision2010-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-24
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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