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    Summary
    EudraCT Number:2013-002517-35
    Sponsor's Protocol Code Number:V00162PI2024A
    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:2013-07-02
    Trial results Removed from public view
    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 number2013-002517-35
    A.3Full title of the trial
    Bronchodilator properties and safety of a repeated dose of V0162 inhalation powder in asthma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bronchodilator properties and safety of a repeated dose of V0162 inhalation powder in asthma
    A.4.1Sponsor's protocol code numberV00162PI2024A
    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 SponsorPierre Fabre Médicament/Institut de Recherche Pierre Fabre
    B.1.3.4CountryFrance
    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 supportInstitut de Recherche Pierre Fabre
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recherche Pierre Fabre-Pierre Fabre Innovation
    B.5.2Functional name of contact pointDr Lucilla MANSUY
    B.5.3 Address:
    B.5.3.1Street AddressCentre de R&D Pierre Fabre-3 avenue Hubert Curien-BP 13562
    B.5.3.2Town/ cityToulouse Cédex 1
    B.5.3.3Post code31035
    B.5.3.4CountryFrance
    B.5.4Telephone number33 (0)534 506339
    B.5.5Fax number33(0)534 506220
    B.5.6E-maillucilla.mansuy@pierre-fabre.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.3.2Product code V0162
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 codeV0162
    D.3.9.3Other descriptive nameD-MEQUITAZINE
    D.3.9.4EV Substance CodeSUB29977
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    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.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 18 microgrammes
    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.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 411207-31-3
    D.3.9.3Other descriptive nameTIOTROPIUM BROMIDE MONOHYDRATE
    D.3.9.4EV Substance CodeSUB21897
    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) 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
    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
    Asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    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 PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the bronchodilator properties of V0162 inhalation powder delivered once daily during 8 days in adult patients with asthma usually treated with ICS and LABA.
    E.2.2Secondary objectives of the trial
    To assess the effect on rescue medication use and the general and local safety of V0162 inhalation powder.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria (checked on Visit 1):
    -Male or female gender.
    -Aged 18 to 65 years-old.
    -18 ≤ BMI <30 kg/m².
    -Clinical history consistent asthma, in the judgement of the investigator.
    -Asthma controlled or partly controlled according to GINA 2012 criteria:
    Less than three of the following items present over the last week:
    1)daytime symptoms more than twice a week,
    2)any limitation of activities,
    3)any nocturnal symptoms/awakening,
    4)need of reliever/rescue treatment more than twice a week
    -Asthma treated by ICS and LABA (fixed-dose combination or free combination) at stable dose for at least 3 months.
    -Able to replace the usual ICS and LABA therapy by ICS at the usual dose regimen and salbutamol as needed.
    -Able to stop salbutamol at least 6 hours before a study visit.
    -Able to perform at least 3 acceptable and reproducible FEV1 and FVC measurements according to ERS/ATS 2005 recommendations.
    -For woman of child bearing potential: negative urine or serum pregnancy test at inclusion and using an efficient contraceptive (surgical or hormonal birth control or intra-uterine device) for at least 2 months before the study and one month after the end of the study, in order to avoid pregnancy while being exposed to the study treatment.
    -Having signed the Informed Consent Form.
    -Likely to be compliant during the study, in the judgement of the investigator.
    -Affiliated to the social security system or being a beneficiary.

    Inclusion criteria (checked on Visit2):
    -No use of salbutamol within the last 6 hours.
    -No use of ultra long-acting Beta2-agonist (indacaterol) and/or long-acting muscarinic-antagonists within the last 48 hours.
    -No use of xanthines or antileukotrienes within the last week.
    -No use of oral and/or intravenous corticosteroids within the last 4 weeks.
    -No use of depot and/or intramuscular corticosteroids within the last 6 months.
    -No use of antihistamines within the last week.
    -Pre-bronchodilation FEV1≥ 60% of the predicted normal value.
    -Reversibility demonstrated by a FEV1 increase ≥12% ((FEV1 post-bronchodilation – FEV1 pre-bronchodilation) / FEV1 pre-bronchodilation) and ≥ 0.200 L (FEV1 post-bronchodilation – FEV1 pre-bronchodilation), 10-20 minutes after acute administration of 4x100 µg salbutamol.

    Inclusion criteria (checked on Visits 3 and 5):
    -Asthma controlled or partly controlled according to GINA 2012 criteria:
    Less than three of the following items present over the last week:
    1)daytime symptoms more than twice a week,
    2)any limitation of activities,
    3)any nocturnal symptoms/awakening,
    4)need of reliever/rescue treatment more than twice a week, considering salbutamol use as reliever if intake exceeds 4 times 2 inhalations per day (taking into account LABA being replaced by salbutamol)

    Stability criterion (checked on Visits 5, 7 and 9):
    -Difference of the measured FEV1 (L) value compared to the previous measurement ≤ 30% (Visit 5 vs Visit 3, Visit 7 vs Visit 5, Visit 9 vs Visit 7)
    If a patient fails to meet that stability criterion, the respective visit may be rescheduled twice.
    E.4Principal exclusion criteria
    Non-inclusion criteria (checked on Visit 1)
    Criteria related to pathologies
    -History of aspirin intolerance or aspirin-induced asthma.
    -History of life-threatening asthma within 5 years (i.e., brittle asthma or requiring hospitalisation in ICU).
    -Clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, COPD, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.).
    -Upper or lower respiratory tract infection within 4 weeks.
    -Exacerbation (requiring oral corticosteroids or hospitalization) within 3 months.
    -Current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years.
    -Intolerance to salbutamol.
    -Intolerance to tiotropium (or any other atropine-derived compound).
    -Intolerance to one of the ingredients of the study product: mequitazine (and more generally all phenothiazine-derived compounds) and lactose.
    -Severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, moderate to severe prostatic hypertrophy, bladder neck obstruction.
    -Any acute or chronic disease that will not allow the participation in the study, in the judgement of the investigator.
    -Clinically relevant physical examination abnormality.
    -Abnormal vital signs (SBP > 140 or < 90 mmHg; DBP > 90 or < 60 mmHg; HR > 100 or < 40 bpm in supine position, unless decision of the Investigator).
    -Abnormal and clinically significant 12-lead ECG (HR > 100 or < 40 bpm, PR > 220 or < 100 ms, QRS > 120 ms, QTcF > 450 ms).
    -Congenital long QT syndrome, known or suspected prolongation of QT interval (QTcF > 450 ms), heart failure, hypokalemia, family history of Long QT syndrome, use of concomitant medications that prolong the QT/QTc interval.
    -Clinically relevant biological (haematology, biochemistry and urinary) exam abnormality, in particular hypokalemia.

    Criteria related to the population
    -Pregnancy or in post-partum period or nursing mother.
    -Alcohol abuse (more than 28 units (male) or 21 units (female) of alcohol a week (unit = 1 glass of wine = 1 glass of spirits = ½ pint of beer)).
    -Drug abuse.
    -Positive serology to HIV antibodies, HCV antibodies and/or HBs antigen.
    -Patients who cannot maintain regular day/night, waking/sleeping cycles (e.g. night shift workers).
    -Patients who are not able to understand the information (for linguistic or psychiatric reasons), in the judgement of the investigator.
    -Patients who had forfeited their freedom by administrative or legal decision, or who are under guardianship or wardship.
    -Patients who cannot be contacted by phone in an emergency.
    -Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Selection Visit (Visit 1)
    E.5 End points
    E.5.1Primary end point(s)
    The main criterion will be the normalised AUC0-24h of FEV1 (L) assessed the last day of each treatment period.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 min pre-dose and 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 22 h, 23 h, 24 h post-dose
    E.5.2Secondary end point(s)
    The secondary criteria, for spirometry, will be
    •the normalised AUC 0-24h of FEV1 (L) assessed the first day of each treatment period,
    •the difference between the last and the first day of each treatment period in normalised AUC 0-24h of FEV1 (L) adjusted for placebo effect,
    as well as the following criteria assessed the first day and the last day of each treatment period and the difference between the last day and the first day within each treatment period adjusted for placebo effect:
    •the normalised AUC 0-9h of FEV1 (L),
    •the normalised AUC 0-12h of FEV1 (L),
    •the peak of FEV1 (L) which is the higher observed post-dosing value,
    •the trough of FEV1 (L) which is the last measurement before the next dosing (i.e. t24h),
    •the normalised AUC 0-9h, AUC 0-12h, AUC 0-24h, peak and trough of FVC, MEF25, MEF50, MEF75, and MEF25-75.
    All the above spirometry criteria made of normalized AUCs will also be derived as baseline-adjusted normalised AUCs, baseline being defined as the predose measurement at the first day of each treatment period.
    The secondary criteria for PEF will be the mean of the daily morning measurements and the daily evening measurements from the first to the last day within each treatment period.
    The secondary criteria for dyspnoea measurements will be the normalised AUC 0-9h, AUC 0-12h, and AUC 0-24h of the dyspnoea measurements (mm) assessed the first and the last day of each treatment period, and the difference between the last and the first day within each treatment period.
    The secondary criteria for rescue medication use will be the number of puffs of rescue medication and the number of days without use during each treatment period.
    E.5.2.1Timepoint(s) of evaluation of this end point
    for more details, please refer to the protocol
    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 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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Preceded by an open-label active-control period before randomisation
    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.8.2.4Number of treatment arms in the trial3
    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.8.6 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
    LVLS
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months8
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state40
    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)
    None
    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 Decision2013-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-07-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-22
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