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    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   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:2007-001968-78
    Sponsor's Protocol Code Number:ADC4022_CLIN_02P
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-05-16
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-001968-78
    A.3Full title of the trial
    A Phase II, Randomised, Double-Blind, Placebo-Controlled Pilot Efficacy Study of ADC4022 (Theophylline Solution for Inhalation) on Markers of Pulmonary Inflammation in Subjects with Moderate to Severe COPD
    A.4.1Sponsor's protocol code numberADC4022_CLIN_02P
    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 SponsorArgenta Discovery Ltd.
    B.1.3.4CountryUnited Kingdom
    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 nameADC4022
    D.3.2Product code ADC4022
    D.3.4Pharmaceutical form Nebuliser solution
    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.3.8INN - Proposed INNtheophylline
    D.3.9.1CAS number 58559
    D.3.9.2Current sponsor codeADC4022
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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) 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.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 Yes
    D.2.1.1.1Trade name Pulmicort Respules 1 mg Nebuliser Suspension
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePulmicort Respules
    D.3.2Product code Budesonide
    D.3.4Pharmaceutical form Nebuliser suspension
    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.3.8INN - Proposed INNBudesonide
    D.3.9.1CAS number 51333223
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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 placeboNebuliser 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
    Chronic Obstructive Pulmonary Disease (COPD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10009033
    E.1.2Term Chronic obstructive pulmonary disease
    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 the effect of ADC4022 (theophylline solution for inhalation), compared to placebo, on markers of pulmonary inflammation (percent neutrophils and absolute neutrophil counts) in induced sputum expressed as percent change from baseline to 4 weeks in subjects with moderate to severe COPD, when co-administered with inhaled budesonide.
    E.2.2Secondary objectives of the trial
    1) Evaluation of ADC4022, compared to placebo, on the following:
    •IL-8 concentration in induced sputum
    •Total induced sputum cell count
    •Macrophages, eosinophils, and lymphocytes in induced sputum
    •Counts of CD8+ and CD68+ cells obtained from bronchial biopsy
    •Pulmonary function as measured by spirometry (FEV1, FVC, FEV1/FVC, and PEFR)
    •Disease control as measured by exacerbation rate and use of rescue medication
    •Symptoms and quality of life as measured by the SGRQ
    •Counts of CD45+, and CD4+ cells and cells expressing genes for TNFα and interferon gamma (IFNγ) obtained from bronchial biopsy.

    2) Evaluation of the tolerability of ADC4022.

    3) Evaluation of the single dose and repeat dose (Day 28) pharmacokinetics of ADC4022.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Screening and Washout Phase

    Subjects meeting all of the following inclusion criteria at Screening should be considered for admission to the study:

    1. The subject is able to understand the requirements of the study and provide written informed consent to participate
    2. The subject is male or female between the ages of 40 and 75 years, inclusive
    3. The subject has a confirmed diagnosis of COPD and has been symptomatic for at least 2 years
    4. The subject has moderate to severe COPD, as defined by the American Thoracic Society and the European Respiratory Society:
    a. Pre-bronchodilator FEV1 predicted ≥40% and <80% and FEV1/FVC ratio ≤70% and
    b. post-bronchodilator FEV1 predicted: ≥40% and <80% and FEV1/FVC ratio ≤70%
    5. The subject can produce an adequate sputum specimen after induction
    6. The subject has a history of ≥ 10-pack years of cigarette smoking
    7. The subject has either a ≤15% increase or ≤200ml increase in FEV1 from pre-dose following a fixed dose of inhaled salbutamol administered by pressurised metered dose inhaler (pMDI, 2 puffs [2x 100 μg])
    8. If the subject is currently being treated with inhaled corticosteroids, they have been on a fixed dose for at least 1 month prior to screening
    9. The subject has a height ≥152 cm
    10. The subject who is also a woman of child-bearing potential (WOCBP) has a negative serum pregnancy test at screening. WOCBP include: any female who has experienced menarche and is not post-menopausal [defined as amenorrhea for >12 consecutive months], or has not undergone surgical sterilization (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). Even women who are using acceptable contraceptive medications or devices to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy) will be considered WOCBP. WOCBP must agree to avoid becoming pregnant for the duration of the 12-week study by using adequate contraception at study entry and throughout the trial. Adequate contraception is defined as appropriate and consistent use of 1 of the following:
    a. Oral contraception
    b. Injectable contraception
    c. Intrauterine device
    d. Implantable device
    e. Double-barrier method (e.g., condom and spermicide)

    WOCBP will be routinely monitored (review at each visit and testing if indicated by the principal investigator [PI]) during study participation for adherence to this criterion.
    11. The subject is able to complete all aspects of the study, including all visits and tests, and is capable of self-administration of study medications (via Pari LC Plus nebuliser delivery systems)
    12. The subject agrees to abide by the study protocol and its restrictions.

    Additional Inclusion Criteria for Run-In and Randomisation

    To be eligible to proceed to the run-in and randomisation periods, subjects must meet the following criteria:

    1. The subject must continue to show evidence of disease stability with no change beyond the normal day-to day variations
    2. The subject must show no evidence of exacerbation, including signs of sustained worsening of the subject’s condition from the stable state and beyond day-to-day variations, that are acute in onset and necessitate a change in regular medication or which warrant a change in medication (Vestbo, 2004)
    3. The subject must show no signs of worsening of respiratory symptoms that require treatment with oral corticosteroids, antibiotics or both and/or hospitalisation due to respiratory symptoms (Vestbo, 2004)
    4. The subject’s spirometry tests at Visits 2 and 3 must show a FEV1 reduction (relative to Visit 1) of less than 20%. FEV1 must still be ≥40% and <80% predicted
    5. The subject has been compliant (i.e., has taken at least 80% but not more than 120% of study medication) during the Run-In period. Subjects who are non-compliant during run-in period will not be permitted to enter the double-blind randomisation treatment period.
    E.4Principal exclusion criteria
    1. The subject has experienced a respiratory tract infection and/or an exacerbation of COPD within 30 days prior to the screening visit. Exacerbation of COPD is defined as a change in symptoms that require:
    a. an increase in use or the addition of one or more of the following therapies: corticosteroids, antibiotics, or oxygen for >3 days; and/or
    b. hospitalization or an extension of a hospitalization within the past 3 months
    2. The subject uses systemic corticosteroids (oral or parenteral)
    3. The subject has received long term oxygen therapy, defined as the daily use of supplemental oxygen for > 12 hours/day, within 30 days prior to the Screening visit
    4. The subject has a previous history or diagnosis of asthma as an adult. Note, subjects who have been diagnosed with asthma are eligible if further investigation and consultation confirms COPD as the correct diagnosis.
    5. The subject has a chest x-ray within 12 months prior to Visit 1 which is diagnostic of an active or clinically significant disease other than COPD
    6. The subject has a history or presence of active tuberculosis, cystic fibrosis, bronchiectasis, lung cancer or sarcoidosis or any other clinically important lung diseases
    7. The subject has had a lobectomy
    8. The subject has a history or presence of severe right sided heart failure (defined as NYHA class III-IV), myocardial infarction, or cor pulmonale within 6 months prior to Screening
    9. The subject has evidence of any unstable or clinically significant, hematopoietic, malignant, cardiovascular, hepatic, renal, neurologic, psychiatric, autoimmune disorder, or condition or disease other than COPD that, in the opinion of the PI, could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives
    10. The subject has any clinically significant laboratory or ECG abnormalities which, per the Investigator’s judgment, could place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives.
    11. The subject has had radiation or chemotherapy within the previous 12 months
    12. The subject is unwilling to discontinue any of the prohibited medications as outlined within the protocol
    13. The subject has a history of hypersensitivity to theophylline or budesonide or any of the excipients used in the preparation of Pulmicort Respules 1mg nebuliser suspension (disodium edetate, sodium chloride, polysorbate 80, citric acid anhydrous, sodium citrate)
    14. The subject has a history of anaphylaxis associated with medicinal products
    15. The subject is pregnant, intends to become pregnant, or is breast feeding
    16. The subject’s alcohol intake is excessive. Excessive is defined as an average daily intake of greater than six units, or a maximum weekly intake of greater than 21 units for males and 14 for females (one unit equals half a pint of beer, one measure of spirits or one glass of wine)
    17. The subject participated in another study (for a marketed drug) within 3 months before the start of this study or (for an investigational drug) within 4 months before the start of this study (prior participation at any time in non-invasive methodology trials in which no drugs were given is acceptable). Participation in another study is considered ended when the subject received their last dose of marketed or investigational drug.
    18. The subject is unable or unwilling to complete all procedures of the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints for statistical comparison between treatment groups will be the percent neutrophils and absolute neutrophil counts in induced sputum. The effect of ADC4022, compared to placebo, will be expressed as percent change from baseline to end-of-study. The baseline neutrophils level in a subject is taken at Visit 3. The end-of-study neutrophils level is taken at Visit 7 (no more than 28 days of 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 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 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 EEA8
    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 Information not present in EudraCT
    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
    Last Visit of the Last Patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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 years0
    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 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) 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 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 state65
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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)
    Normal Treatment
    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 Decision2007-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-01-06
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