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    Summary
    EudraCT Number:2008-008394-63
    Sponsor's Protocol Code Number:CNVA237A2303
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2008-008394-63
    A.3Full title of the trial
    A 52-week treatment, randomized, double-blind, placebo-controlled, with open label tiotropium, parallel-group study to assess the efficacy, safety and tolerability of NVA237 in patients with chronic obstructive pulmonary disease
    A.4.1Sponsor's protocol code numberCNVA237A2303
    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.3.1Product nameNVA237
    D.3.2Product code NVA237
    D.3.4Pharmaceutical form Capsule, hard
    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 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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Spiriva
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameSpiriva
    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 INNtiotropium bromide
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    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 placeboCapsule, hard
    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 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
    To confirm that NVA237 50µg o.d. (delivered via a SDDPI) vs placebo significantly increases mean 24 h post-dose (trough) FEV1 following 12 weeks of treatment in patients with moderate to severe COPD (GOLD Guidelines 2008)
    E.2.2Secondary objectives of the trial
    Key:
    • evaluate the effect of NVA237 (50µg o.d.) vs placebo on breathlessness measured using the Transition Dyspnea Index (TDI) after 26 weeks treatment.
    • evaluate the effect of NVA237 (50µg o.d.) vs placebo on the total score of the St George’s Respiratory Questionnaire (SGRQ) after 52 weeks treatment.

    Important secondary objectives/variables
    • evaluate the effect of NVA237 (50µg o.d.) vs placebo on time to first COPD exacerbation during 52 weeks treatment.
    • evaluate the effect of NVA237 (50µg o.d.) vs placebo on daily rescue medication use (number of puffs) over 52 weeks.

    Note: Additionnal secondary comparisons are outlined in the protocol

    Additional safety assessment:
    • assess the safety of NVA237 by following up on all patients’ life status (survival information) and cause of death (if applicable) during 56 weeks (52 weeks randomized treatment period plus 4 weeks follow up).
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Full title: exploratory pharmacogenetic assessments, 17 april 2009, version 2

    Objectives:
    Exploratory pharmacogenetic assessments are planned as a part of this study with the objectives of examining whether individual genetic variation in genes relating to drug metabolism, COPD, and the drug target pathway confer differential response to NVA237
    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 moderate to severe stable COPD (Stage II or Stage III) according to the (GOLD Guidelines 2008).
    3. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten pack-years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
    4. Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (day -14)
    5. Patients, according to daily electronic diary data between Visit 2 (-14) and Visit 3 (day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3 (For scoring information see Section 7.4.3.1.)
    E.4Principal exclusion criteria
    1. Pregnant women or nursing mothers
    2. Women of child-bearing potential, as defined in the protocol
    3. Patients requiring long term oxygen therapy (> 15 h a day) 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 (day -21) and Visit 3 (day 1).
    4. Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1 (day -21). Patients who develop a lower respiratory tract infection or COPD exacerbation during the screening period (up to Visit 3 (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 lower respiratory tract infection).
    5. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to):
    • unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding chronic stable AF)
    • history of malignancy of any organ system (including lung cancer), 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.
    • narrow-angle glaucoma
    • symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention
    • any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
    6. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at visit 1) or onset of symptoms prior to age 40 years.
    7. Patients contraindicated for tiotropium or ipatropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents.
    8. Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
    9. Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (day -21) (Fridericia method) is prolonged (>450 ms for males or >470 for females).
    10. Treatments for COPD and allied conditions: the following medications should not be used between Visits 1 (day -21) and 3 (day 1).
    The minimum washout prior to Visit 2 (Day -14) is specified below. For patients in the Holter monitor sub-group minimum washout is prior to the day before Visit 2 (day -15):
    • The long acting anticholinergic agent tiotropium:7 days.
    • Short acting anticholinergics: 8 h
    • Fixed combinations of β2-agonists and inhaled corticosteroids: 48 hours. (Patients taking fixed combinations of β2-agonists and inhaled corticosteroids must be switched to the equivalent inhaled corticosteroid as monotherapy plus salbutamol/albuterol as rescue therapy at least 48 hours prior to Visit 2)
    • Long-acting β2-agonists: 48 h
    • Short acting β2-agonists (other than those prescribed in the study): 6 h
    • Theophylline (any formulation): 7 days
    • Combinations of inhaled short acting anticholinergics and short acting β2-agonists: 12 hours
    11. Patients who need the following treatments for COPD and allied conditions unless they have been stabilized as follows:
    • Inhaled corticosteroids, in recommended and constant doses and dose regimens (previously given as part of a fixed dose combination of LABA + ICS) – at least one month prior to Visit 1.
    • Intranasal corticosteroids, in recommended and constant doses and dose regimens - at least one month prior to Visit 1.
    • H1 antagonists at least 5 days prior to Visit 1.
    12. Patients taking non selective beta-blocking agents.
    13. Long term oral prednisone therapy (or equivalent), defined as ≥ 10mg daily for at least 1 month prior to Visit1 (day-21).
    14. A history of hypersensitivity to any of the study drugs, including rescue medication, or to drugs from a similar drug class.
    15. Patients unable to use a dry powder inhaler (SDDPI) device or pressurized MDI (rescue medication).
    16. Patients unable to use an electronic patient diary.
    17. Patients who are, in the opinion of the investigator known to be unreliable or non-compliant, or with any condition or prior or present treatment rendering the patient not eligible for the study.
    18. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of Visit 1 (day -21), whichever is longer.
    19. Patients in the active phase of a supervised pulmonary rehabilitation programme.
    20. Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency.
    21. Patients taking cromoglycate, nedocromil, ketotifen and leukotriene antagonists.

    You will find other exclusion criteria within the protocol

    E.5 End points
    E.5.1Primary end point(s)
    Mean trough FEV1 after 12 weeks treatment imputed with LOCF
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    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) 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) Yes
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA65
    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
    Provided in the protocol, section 6.5.11.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    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 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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 1065
    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)
    Provided in the protocol, section 6.5.10.
    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 Decision2009-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-10-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-04-28
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