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    Summary
    EudraCT Number:2008-006849-28
    Sponsor's Protocol Code Number:CNVA237A2207
    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:2009-01-21
    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 number2008-006849-28
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multi-center, two-period crossover study to investigate the bronchodilatory effect of 50µg NVA237 inhaled once daily in patients with Chronic Obstructive Pulmonary Disease (COPD)
    A.4.1Sponsor's protocol code numberCNVA237A2207
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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.3.2Product code NVA237
    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.3.8INN - Proposed INNglycopyrrolate
    D.3.9.1CAS number 596-51-0
    D.3.9.2Current sponsor codeNVA237
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Mild, moderate or severe 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 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
    Investigate the bronchodilatory efficacy of 50µg NVA237 over 24 hours following 14 days treatment when compared to placebo.
    E.2.2Secondary objectives of the trial
    •Investigate the peak bronchodilator effect of NVA237
    •Investigate the trough bronchodilator effect at the end of the 24 h assessment interval
    •Investigate the bronchodilator effect on the first and second portion of the 24 h assessment interval (0h – 12h and 12h – 24 h after 14 days dosing)
    •Investigate the bronchodilator effects on NVA237 on Day 7 (in analogy to those on Day 14)
    •Investigate the safety and tolerability of 50µg NVA237 in COPD patients
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
    2. Patients with mild, moderate or severe COPD according to the GOLD Guidelines (2007).
    3. Current or ex-smokers who have smoking history of at least 10 pack years.
    4. Patients with a post-bronchodilator FEV1 ≥30% of the predicted normal, and post-bronchodilator FEV1/FVC ≤ 0.7 at Visit 1.
    5. FEV1 increase by 5% or more in bronchial reversibility test with 40 µg ipratropiumbromide
    E.4Principal exclusion criteria
    1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
    2. Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS (1) they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m, OR (2) have past 6 weeks from surgical bilateral oophorectomy with or without hysterectomy OR (3) are using one of the following acceptable methods of contraception: surgical sterilization (e.g. bilateral tubal ligation) and the double barrier method consisting of diaphragma plus condome. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. NOTE: Reliable contraception must be maintained throughout the study
    3. Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 3.
    4. Patients who have had a respiratory tract infection within 6 weeks prior to screening. Patients who develop a respiratory tract infection during the screening period (up to Day -1) will not be eligible, but will be permitted to be re-screened at a later date (at least 6 weeks after the resolution of the respiratory tract infection).
    5. Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition which would compromise patient safety or compliance. Patients with the following medical conditions are specifically excluded from the study: unstable ischemic heart disease, left ventricular failure, long term prednisone therapy, history of myocardial infarction, relevant cardiac arrhythmia
    6. Patients who have contraindications for anti-muscarinic drugs such as narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment.
    7. Patients with a history of asthma indicated by (but not limited to) onset of symptoms prior to the age of 40 years.
    8. Patients who have shown an untoward reaction to inhaled anticholinergic agents.
    9. Patients with a history of long QT syndrome or whose QTc measured at screening (Fridericia method) is prolonged (>450 ms for males or >470 ms for females).
    10. Treatments for COPD and allied conditions: the following medications should not be used between screening and end of study. The minimum washout prior to treatment periods is specified below where applicable:
    The long acting anticholinergic agent tiotropium:7 days.
    Short acting anticholinergics: 8 h
    Patients taking fixed combinations of beta2-agonists and inhaled corticosteroids should be switched to the corresponding dose of inhaled corticosteroid and rescue on-demand short acting beta2-agonists medication. The minimum washout period of 48 hours for long acting 2-agonists should be adhered to.
    Long-acting beta2-agonists: 48 h
    Short acting beta2-agonists (other than those prescribed in the study): 6 h
    Theophylline (any formulation): 7 days
    Combinations of inhaled anticholinergics and β agonists: 24 hours
    11. Patients who need the following treatments unless they have been a stable dosing regimen for at least one month prior to first study treatment: Cromoglycate, nedocromil, ketotifen, inhaled corticosteroids in recommended and constant doses and dose regimens
    12. Patients unable to use the Concept1 or a pMDI (rescue medication) or perform spirometry measurements.
    13. Patients taking β blocking agents that are not highly β-1 receptor selective
    14. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of dose administration on day 1, whichever is longer.
    15. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
    16. Urinary Retention
    E.5 End points
    E.5.1Primary end point(s)
    Investigate the bronchodilatory efficacy of 50µg NVA237 over 24 hours following 14 days treatment when compared to placebo.
    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) 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 No
    E.8.1.6Cross over Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    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 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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 32
    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 Decision2009-01-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-05-07
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