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    Summary
    EudraCT Number:2006-001193-25
    Sponsor's Protocol Code Number:D9830C00003
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-06-07
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2006-001193-25
    A.3Full title of the trial
    A 4 week randomised, double blind, placebo controlled, parallel group,
    phase II, PoP study to assess the efficacy and safety of AZD1981 in adult
    patients with asthma.
    A.4.1Sponsor's protocol code numberD9830C00003
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 Information not present in EudraCT
    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 nameAZD1981
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Information not present in EudraCT
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms Information not present in EudraCT
    D.3.11.11Herbal medicinal product Information not present in EudraCT
    D.3.11.12Homeopathic medicinal product Information not present in EudraCT
    D.3.11.13Another type of medicinal product Information not present in EudraCT
    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 placeboOral solution
    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
    Asthma
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Information not present in EudraCT
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to compare the clinical efficacy of twice daily, orally administrated AZD1981 with that of placebo over a 4-week treatment period in adults with persistent asthma.
    E.2.2Secondary objectives of the trial
    A secondary objective of the study is to evaluate the safety and tolerability. Other secondary objectives are pharmacokinetics, exploratory pharmacodynamics, and pharmacogenetics of AZD1981 given at repeated oral doses.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Provision of ICF (Informed Consent Form) could be obtained at an information
    visit prior to Visit 1 or at Visit 1 (according to local regulations), but before any
    study related procedures has been performed.
    2. Men and post menopausal or surgically sterilized women, aged 18-60 years.
    Women will be considered post menopausal if they have been amenorrheic for at
    least 12 months, and an FSH plasma concentration within the post menopausal
    range as defined by the laboratory.
    3. Minimum of 6 month’s documented history of asthma according to the ATS
    definition (ATS 1987).
    4. Daily use of ≤400 µg inhaled GCS during 30 days prior to Visit 1.
    5. FEV1 ≥60 - <100% of predicted normal value pre-bronchodilator.
    6. Reversible airway obstruction either according to the reversibility test performed
    at Visit 1, or as historic data found in medical record (not older than 2 years)
    Reversibility is defined as an increase in FEV1 of ≥12% relative baseline and
    ≥200 mL after an inhalation of in total 1 mg Bricanyl Turbuhaler. If not fulfilled at
    Visit 1, criterion No 11 should be fulfilled at Visit 2.
    7. The patient must not have had a clinically important asthma exacerbation, as
    judged by the investigator, one month before Visit 1.
    8. A positive skin prick test to airway allergens (at least one) such as: pollen from
    birch, grass, or mugwort, animal fur for example dog, cat, horse, or house dust
    mite at Visit 1 or as historic data found in medical records not older than 2 years.
    9. Able to read and write and use electronic devices.
    10. Use of as-needed medication at least 4 times during the last week of the run-in
    period.
    11. If the reversibility criterion is not met at Visit 1 (either from historic data or
    from the spirometry measurement) the patient must either show an increase in
    FEV1 of ≥12% relative baseline and ≥200 mL after an inhalation of in total 1 mg
    Bricanyl Turbuhaler or show a variation in PEF of at least 20% on at least 2 days
    during the run-in period. This should be calculated as follows: (max PEF - min
    PEF) / max PEF (all values from the same day).
    12. The patient must not have taken more than 12 inhalations of as-needed medication
    on any single day during the run-in period.
    13. The patient must not have had a clinically important asthma exacerbation, as
    judged by the investigator, during the run-in period.
    14. Patients must not have used 8 inhalations or more of as-needed medication/24
    hours on more than 2 days/week (any 7 days period) during the run-in period.
    15. The patient must not have used iGCS during the run-in period.
    16. No clinical relevant abnormal findings in clinical chemistry, haematology, FSH
    (females only), urinalysis, which, in the opinion of the investigator, may put
    patient at risk because of his/her participation in the study.
    17. Provision of informed consent for pharmacogenetic research
    E.4Principal exclusion criteria
    1. Inability to tolerate withdrawal of asthma therapy as required for the study.
    2. Hospitalisation for asthma within the last 2 years prior to Visit 1.
    3. Respiratory infection significantly affecting the asthma, as judged by the
    investigator, within 30 days prior to Visit 1.
    4. Any of the following:
    - current smoker,
    - patient with a history of smoking for more than 10 pack years (one pack year= 1
    pack (20 cigarettes) per day for 1 year or equivalent),
    - ex-smoker since less than 1 year.
    5. Body Mass Index (BMI) <18 kg/m 2 and body weight <50 kg.
    6. A history of additional risk factors for Torsade de pointes (eg, heart failure,
    hypokalemia, family history of Long QT syndrome).
    7. Use of concomitant medications that prolong the QT/QTc interval other than
    terbutaline or albuterol.
    8. Use of β -blocker medication (including eye-drops)
    9. Pregnancy or breast feeding.
    10. Any significant disorder (eg, cardiovascular, pulmonary (other than asthma),
    gastrointestinal, hepatic, renal, neurological, musculosceletal, infectious,
    endocrine, metabolic, malignant, psychiatric, major physical impairment) which,
    in the opinion of the investigator, either put the patient at risk because of
    participating in the study or may influence the results of the study, or the patients
    ability to participate in the study.
    11. Any clinical relevant abnormal findings in physical examination, pulse, blood
    pressure or ECG at Visit 1, which, in the opinion of the investigator, may put
    patient at risk because of his/her participation in the study.
    12. Previous randomisation of treatment into the present study, see Section 3.5.
    13. Planned hospitalisation during the course of the study.
    14. Suspected poor capability to follow instructions of the study, as judged by the
    investigator.
    15. Past or present alcohol or drug abuse.
    16. Involvement in the planning and conduct of the study (applies to both AstraZeneca
    staff and staff at the study site).
    17. Patients currently on immunotherapy, or who have had a course within the last
    2 years.
    18. Participation in another clinical study involving an investigational product within
    3 months before Visit 1.
    E.5 End points
    E.5.1Primary end point(s)
    ThePrimary outcome variable for evaluation of the effect of AZD1981 is
    change in:morning peak expiratory flow (mPEF) from baseline (mean of the 10 last
    days of the run-in period) to the treatment period (mean of the 4-week
    treatment period)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Information not present in EudraCT
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Information not present in EudraCT
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Information not present in EudraCT
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    n/a
    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 months1
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Information not present in EudraCT
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 110
    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)
    As described for local practice
    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 Decision2006-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-07-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2007-08-28
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