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    Summary
    EudraCT Number:2010-018597-20
    Sponsor's Protocol Code Number:CNVA237A2310
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-10
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-018597-20
    A.3Full title of the trial
    A multi-center, randomized, double-blind, placebocontrolled, two-period cross-over study to assess the effect of 50 µg inhaled NVA237 on exercise endurance in patients with moderate to severe COPD
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberCNVA237A2310
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 FARMA
    B.1.3.4CountryItaly
    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 nameGlycopyrrolate
    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.3.9.1CAS number 596510
    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
    Chronic obstructive pulmonary disease (COPD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level SOC
    E.1.2Classification code 10038738
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effect of 50 μg NVA237 compared with matching placebo inhaled once
    daily on exercise tolerance as measured by exercise endurance time during a sub-maximal
    constant-load cycle ergometry test (SMETT) after three weeks of treatment.
    E.2.2Secondary objectives of the trial
    Key sec.obj.:To determine the effect of 50 μgNVA237 compared with plac.on isotime inspiratory capacity during SMETT after 3weeks of treatment.
    • To determine the effect of 50μg NVA237 compared with plac.on inspiratory capacity at rest and at peak during SMETT after 3 weeks of treatment.• To determine the effect of 50 μg NVA237 compared with plac.on peak and trough (i.e.24 h post dose) FEV1 after 3 weeks of treatment.
    • To evaluate the effects of 50 μg NVA237 compared to plac.on Slow Vital Capacity, Forced Vital Capacity, Specific Airway Conductance and Total
    Lung Capacity after 3 weeks of treatment.• To evaluate the effect of 50 μg NVA237 compared to placebo on exertional dyspnea during SMETT after 3weeks treatment.• To evaluate the effect of 50 μg NVA237 compared to placebo on leg discomfort during SMETT after3 weeks treatment.-To determine the effect of a single dose on treat.Day1 of 50μgNVA237 compared with plac.on exercise tolerance as measured byExer.EnduranceTime duringSMETT
    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 moderate to severe stable COPD (clinical diagnosis in compliance with 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 ≥35% and < 70% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 during screening.
    (Post refers to 30 min after inhalation of 80 μg ipratropium bromide).
    5. Increase in FEV1 from Pre-bronchodilator to Post-bronchodilator assessment of at least 5%.
    E.4Principal exclusion criteria
    - Pregnant women or nursing mothers or of child-bearing potential except for the cases listed into protocol. - Patients who have had a COPD exacerbation in the 6 weeks prior to Visit 1 or between V. 1 and V. 4.- Patients who have had a lower respiratory tract infection in the 6 weeks prior to V. 1.- Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.- Patients with resting (5 min) oxygen SaO2 saturation on room air of < 85%.- Patients with a Wmax value <20 W at V. 2.-Patients, whose exercise endurance time at sub-maximal workload is above 25 min at baseline; - Patients with contraindications (see example into Protocol) to cardiopulmonary exercise testing ;- Patients involved in the active phase of a supervised Pulmonary Rehabilitation Program.- Patients who have a clinically relevant laboratory abnormality or a clinically significant condition such the ones described into the Protocol as example; - Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency.- Patients with concomitant pulmonary disease, e.g., pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis.- Patients with any history of asthma or with allergic rhinitis who use H1 antagonists or intranasal corticosteroids intermittently are to be excluded. Treatment with a stable dose is permitted (constant dose for at least 1 month prior to V. 2).- Patients with a history of long QT syndrome or whose QTc is prolonged at screening. - Patients who have a clinically significant abnormality on the screening or baseline ECG who in the judgement of the investigator would be at potential risk if enrolled into the study. - Patients contraindicated for treatment with, or having a history of reactions/hypersensitivity to any of the class drugs described into the Protocol, included, for example, anti-cholinergic agents, long- and short-acting β2-agonists, sympathomimetic amines; - Treatments for COPD and allied conditions: the medications described into the Protocol should not be used between V. 1 and V. 4 and then through the subsequent course of the study. Further to this, into the Protocol, is specified the minimum washout prior to V. 2.- Patients who need the following treatments for COPD and allied conditions (e.g. allergic rhinitis) unless they have been stabilized as follows: Inhaled corticosteroids in recommended and constant doses and dose regimens (previously given as either part of a fixed dose combination of LABA+ICS or ICS as monotherapy) for at least 1 month prior to V. 2, Intranasal corticosteroids in recommended and constant doses and dose regimens for at least 1 month prior to V. 2, H1 antagonists in recommended and constant doses and dose regimens for at least 5 days prior to V. 2;- Other excluded medications: Leukotriene antagonists (7 days prior to V. 2), Cromoglycate, nedocromil, ketotifen (7 days prior to V. 2), Intramuscular glucocorticosteroid e.g. Kenalog: unless discontinued 3 months prior to V. 2, Parenteral or oral glucocorticosteroids unless discontinued 1 month prior to V. 2;- Patients unable to use a dry powder inhaler device or pressurized rescue medication) or unable to use an electronic patient diary;- Patients who are known to be unreliable or noncompliant or with any condition or prior or present treatment rendering the patient not eligible for the study;- Use of other invest. drugs at the time of enrollment, or within 30 days or 5 halflives of V. 1, whichever is longer.- Patients whose endurance in the exercise test is limited by non–respiratory conditions.
    E.5 End points
    E.5.1Primary end point(s)
    Primary PD endpoint is exercise endurance at week three.
    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) 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 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 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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 years0
    E.8.9.1In the Member State concerned months9
    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 months10
    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 60
    F.4.2.2In the whole clinical trial 80
    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 Decision2010-09-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-08
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