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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .
     
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    Summary
    EudraCT Number:2013-000262-11
    Sponsor's Protocol Code Number:CCD_01535BC1_01
    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:2013-05-16
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-000262-11
    A.3Full title of the trial
    An Open Label Placebo Study To Assess The Inhalation Profile Obtained By Acoustic Monitoring In COPD Patients Using The NEXThaler® Dry Powder Inhaler (DPI) Device.
    Studio in aperto con placebo per valutare il profilo di inalazione, mediante monitoraggio acustico, in pazienti con COPD che usano dispositivo per inalazione NEXThaler® a polvere secca (DPI)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the inhalation profile obtained by acoustic monitoring in COPD patients using the inhaler NEXThaler®
    Studio per valutare il profilo inalatorio attraverso un monitoraggio acustico in pazienti con COPD utilizzando l'inalatore NEXThaler®
    A.4.1Sponsor's protocol code numberCCD_01535BC1_01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorChiesi Farmaceutici S.p.A.
    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 supportChiesi
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCROMSOURCE
    B.5.2Functional name of contact pointProject Management unit
    B.5.3 Address:
    B.5.3.1Street AddressVia Scuderlando 10
    B.5.3.2Town/ cityVerona
    B.5.3.3Post code37135
    B.5.3.4CountryItaly
    B.5.4Telephone number00390458222811
    B.5.5Fax number00390458222812
    B.5.6E-mailjenny.zecchini@cromsource.com
    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 nameCHF 1535 NEXThaler® Placebo
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    COPD
    E.1.1.1Medical condition in easily understood language
    patients with COPD
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10010952
    E.1.2Term COPD
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to assess the inspiration profile through the NEXThaler® device in COPD patients with varying degrees of airflow limitation as per GOLD 2013 (updated) spirometric classification of disease severity.
    L’obiettivo primario di questo studio é di valutare il profilo del flusso inalatorio attraverso l’inalatore a polvere secca NEXThaler® in pazienti BPCO con diversi gradi di limitazione respiratoria secondo la classificazione spirometrica di severità della malattia GOLD 2013 (aggiornata).
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to evaluate the potential correlation between the lung function parameters measured by spirometry at clinic and the variables measured by acoustic monitoring technology during the inspiratory manoeuvre.
    L’obiettivo secondario di questo studio è di valutare la potenziale correlazione tra i parametri della funzionalità polmonare misurata attraverso la spirometria al centro e le variabili misurate attraverso la tecnologia del monitoraggio acustico durante la manovra inspiratoria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent obtained from the patient and/or the legal representatives
    2. Inpatients and outpatients of both sexes, aged ≥ 40 years
    3. Documented clinical diagnosis (within the past 6 months) of COPD with varying degrees of airflow limitation based on Spirometric classification of disease severity according to GOLD 2013 (updated) guidelines with a smoking history of at least 10 pack years (pack-years = the number of cigarette packs per day times the number of years). Current smokers and ex-smokers are eligible
    4. A cooperative attitude and ability to use DPIs and to be trained in the proper use of the NEXThaler® as confirmed by the activation of the training device BAM
    1. Consenso Informato scritto ottenuto dal paziente
    2. Pazienti ricoverati e non, di entrambi i sessi, con età ≥ 40 anni
    3. Diagnosi clinica documentata (negli ultimi 6 mesi) di BPCO con vari gradi di limitazione respiratoria secondo la classificazione spirometrica di severità della malattia GOLD 2013 (aggiornata) con un passato da fumatore di almeno 10 pacchetti / anno (un pacchetto / anno = numeri di pacchetti di sigarette fumati al giorno moltiplicato per il numero di anni). Sia fumatori attuali che ex-fumatori sono arruolabili.
    4. Attitudine alla collaborazione e abilitá nell’uso del NEXThaler® e ad essere trainati sull’uso corretto del NEXThaler® come confermato dall’attivazione del BAM dell’apparecchio per il training
    E.4Principal exclusion criteria
    1. Pregnant women confirmed by a positive pregnancy test or nursing (lactating) women (if applicable)
    2. Diagnosis of asthma
    3. Diagnosis of restrictive lung disease
    4. Allergy to any component of the placebo treatment
    5. Inability to comply with study procedures or treatment
    6. Significant unstable medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any previously documented laboratory abnormality indicative of a significant underlying condition, that may interfere with patient’s safety, compliance, or study evaluations, according to the investigator’s opinion.
    1. Donna in gravidanza confermata da un test di gravidanza positivo o donna in fase di allattamento
    2. Diagnosi di asma
    3. Diagnosi di malattia polmonare restrittiva
    4. Allergia ai componenti del placebo
    5. Incapacità di aderire alle procedure dello studio o al trattamento
    6. Anamnesi positiva per significativa instabilità clinica e/o in trattamento per malattie cardiache, renali, neurologiche, epatiche, endocrine, o ogni anormalità di laboratorio, precedentemente documentata, indicativa di condizione patologica associata significativa che possa interferire con la sicurezza del paziente, adesione allo studio, o con le valutazioni dello studio secondo l’opinione dello sperimentatore
    E.5 End points
    E.5.1Primary end point(s)
    NA
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    Explorative study To Assess The Inhalation Profile
    Studio esplorativo per valutare il profilo inalatorio
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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.8.5The trial involves multiple Member States No
    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 No
    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
    LPLV
    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 months8
    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 months0
    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.1.2.1Number of subjects for this age range: 59
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-05-16. Yes
    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 state89
    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 continue with their standard care
    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 Decision2013-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-09-24
    P. End of Trial
    P.End of Trial StatusCompleted
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