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    Summary
    EudraCT Number:2006-001975-40
    Sponsor's Protocol Code Number:1219.5
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-11-16
    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 ConcernedGermany - BfArM
    A.2EudraCT number2006-001975-40
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, parallel group study to evaluate the effects of a 4-week treatment of 15 mg b.i.d BIBW 2948 BS (inhalation powder, hard capsule for HandiHaler®) on epithelial mucin stores and the safety and efficacy in COPD patients with symptoms associated with chronic bronchitis
    A.3.2Name or abbreviated title of the trial where available
    Effects of BIBW 1948 on epithelial mucin
    A.4.1Sponsor's protocol code number1219.5
    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 SponsorBoehringer Ingelheim Pharma GmbH & Co. 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 nameBIBW2948 BS inhalation powder, hard capsule
    D.3.2Product code BIBW2948 BS
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeBIBW2948BS
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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) 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) No
    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 placeboInhalation powder, hard capsule
    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
    Chronic Obstructive Pulmonary Disease (COPD) patients with symptoms associated with chronic bronchitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The general aim of this study is to evaluate the effects of a 4-week treatment of BIBW 2948 BS on epithelial mucin stores in patients with COPD associated with symptoms of chronic bronchitis. Additionally the safety and tolerability of a 15 mg b.i.d. dose of BIBW 2948 BS via the HandiHaler® device will be evaluated.

    The primary efficacy variable for the study will be the volume of mucin per surface area of basal lamina (Vs mu,bala). Vs mu,bala will be determined by stereologic quantification of per-iodic acid Schiff's reagent AB/PAS staining in endobronchial biopsies at Visit 2 (baseline) and at the end of the 4-week period of randomised treatment (Visit 5).
    E.2.2Secondary objectives of the trial
    Secondary endpoints:

    1)Volume of mucin per volume of epithelium (Vv mu, ep) in endobronchial biopsies
    2)Total and Differential Cell Counts in bronchoalveolar lavage (BAL)
    3)Mucin gene, and epidermal growth factor receptor (EGFR) gene expression
    (RNA) in epithelial brushings
    4)EGFR and phosphorylated EGFR expression (Protein) in epithelial brushings
    5)Goblet cell size and number in endobronchial biopsies
    6)Interleukin-8 (IL-8) levels in bronchoalveolar lavage
    7)Myeloperoxidase (MPO) levels in bronchoalveolar lavage.
    8)Pharmacokinetics after single and multiple doses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication restrictions.

    2. All patients must have a diagnosis of COPD.

    3. Patients must have post-bronchodilator forced expiratory volume in 1 second/forced vital capacity FEV1/FVC <70% and FEV1 ≥ 40% predicted. (See Appendix 5 for predicted normal values.)

    4. Patients should have symptoms associated with chronic bronchitis and must have symptoms of cough and sputum production on most days during at least 3 months for 2 consecutive years.

    5. Male and females between the ages of 40 and 70 years

    6. Patients who are actively smoking at least 10 cigarettes a day, have a smoking history of 10-pack years or more.

    7. Patients must be able to read and understand the questionnaires in the languages provided (English in the U.S. and Ireland, German in Germany).

    8. Patients must be able to perform technically acceptable pulmonary function tests, undergo bronchoscopy, and all associated study procedures in the opinion of the investigator.

    9. Patients must be able to inhale medication in a competent manner from the HandiHaler device for BIBW 2948 BS.
    E.4Principal exclusion criteria
    1. Patients with significant diseases other than COPD or chronic bronchitis are excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the subject at risk because of participation in the study or a disease which may influence the results of the study or the subject’s ability to participate in the study.

    2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis if the abnormality defines a significant disease as defined in exclusion criteria No. 1.

    3. All patients with a serum glutamate oxaloactetate transferase (SGOT) >80 IU/L, SGPT >80 IU/L, bilirubin >2.0 mg/dL or creatinine >2.0 mg/dL will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these patients.

    4. Patients with a history of thoracotomy with pulmonary resection.

    5. Patients with known active tuberculosis.


    6. Patients with current significant psychiatric disorders.

    7. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.

    8. Patients with history of asthma or allergic rhinitis.

    9. Patients with a history of sinusitis within the last 3 months.


    10. Patients with a significant history of alcohol or drug abuse or current significant use of these substances based on the investigators judgement.

    11. Use of oral corticosteroids in the 4 weeks prior to screening or during the baseline or treatment periods will be excluded. The use of inhaled corticosteroids (ICS) will be permitted provided there are no changes to the therapeutic plan in the prior 6 weeks (or at any time during the study)..

    12. Patients who are being treated with cromolyn sodium or nedocromil sodium.


    13. Patients with a dependence of supplementary oxygen for activities of daily living.

    14. Patients who have experienced an exacerbation of COPD or chronic bronchitis (purulent sputum, significant worsening of the symptoms, etc.) in the six weeks prior to the Screening Visit (Visit 1) or between Visits 1 and 3 will be excluded.

    15. Patients who have taken an investigational drug within 1 month or 6 half lives of the active ingredient (what ever is greater) prior to screening visit (Visit 1).

    16. Patients with a recent history (i.e., one year or less) of myocardial infarction.

    17. Patients with a recent history (i.e., three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.

    18. Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years.

    19. Patients who have had changes in their pulmonary therapeutic plan within the last four weeks prior to the Screening Visit (Visit 1).

    20. Previous participation in this study, or current participation in other clinical study.

    21. Women are of child-bearing potential or who have not been post menopausal for a duration of less than 2 years and have not a hysterectomy or tubal ligation procedure.

    22. Patients using anticoagulation or antiplatelet therapy (within 6 half lives time prior to bronchoscopy procedure) or those that have a predisposition to uncontrolled bleeding events.

    23. Donation of greater than 100 mL of blood within the past 2 weeks prior to screening.

    24. Patients with known hypersensitivity to lactose or any other components of the inhalation capsule delivery system.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable for the study will be the volume of mucin per surface area of basal lamina (Vs mu,bala). Vs mu,bala will be determined by stereologic quantification of AB/PAS staining in endobronchial biopsies at Visit 2 (baseline) and at the end of the 4-week period of randomised treatment (Visit 5).
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    The trial will be completed when the trial clinical monitor confirms that 48 subjects will complete visit 7, or unless an unforseen risk to the enrolled patients is identified.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 24
    F.4.2.2In the whole clinical trial 60
    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 resume normal therapy with follow up for SAEs.
    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 Decision2007-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-07-09
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