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    Summary
    EudraCT Number:2012-001483-29
    Sponsor's Protocol Code Number:CCD-1202-PR-0080
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-06-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-001483-29
    A.3Full title of the trial
    A RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED, THREE-WAY CROSSOVER STUDY TO EVALUATE THE EFFICACY AFTER ALLERGEN CHALLENGE, SAFETY, AND TOLERABILITY OF TWO DOSES OF INHALED CHF6001 DPI AFTER 9 DAYS OF TREATMENT IN ADULT PATIENTS WITH ASTHMA.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at the safety, tolerability and efficacy of repeated doses of different concentrations of the study drug during controlled inhalation of allergens in adult asthmatics.
    A.4.1Sponsor's protocol code numberCCD-1202-PR-0080
    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 Farmaceutici S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChiesi Farmaceutici S.p.A.
    B.5.2Functional name of contact pointSara Collarini
    B.5.3 Address:
    B.5.3.1Street AddressVia Palermo 26/A
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43122
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 0521 279 948
    B.5.6E-mails.collarini@chiesi.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 CHF6001 DPI
    D.3.4Pharmaceutical form Inhalation powder, hard capsule
    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 codeCHF6001 DPI
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 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
    asthma
    E.1.1.1Medical condition in easily understood language
    difficulty in breathing
    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 14.1
    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 determine the effect of CHF6001 DPI in attenuating the late asthmatic response (LAR) after an allergen challenge (AC) following 9 days of inhaled dosing in adult patients with allergic asthma.
    E.2.2Secondary objectives of the trial
    • To determine the effect of CHF6001 DPI in attenuating the early asthmatic response (EAR) after an allergen challenge,
    • To assess the responsiveness to a methacholine (MCh) challenge 24 hours after an allergen challenge,
    • To assess the allergen induced changes in sputum eosinophils, neutrophils and mediators (Eosinophilic cationic protein (ECP), neutrophil elastase (NE), Interleukin-5 (IL-5), IL-8, Eotaxin) 10 hours after an allergen challenge,
    • To assess safety and tolerability,
    • To measure systemic exposure to CHF6001 and its metabolites CHF5956 and CHF 6095
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Written informed consent (IC) prior to any studyrelated
    procedures;
    2.Non or exsmokers
    3.Male or female aged between 18 and 60 years;
    4.Body mass index between 18 and 32 kg/m2 inclusively;
    5.A cooperative attitude and ability to be trained about the proper use of the Aerolizer® DPI and to perform spirometry;
    6.Diagnosis of intermittent or persistent mild to moderate allergic asthma, steroidnaïve and generally in good health;
    7.Predisposition to an allergic reaction (atopy) to at least one common
    aeroallergen
    8.At the time of randomisation, a confirmed “dualresponder”
    having demonstrated both a late asthmatic response and an early asthmatic response.
    9.Sputum producer cohort only: able to produce an adequate induced sputum sample,
    10 hours after the allergen challenge at screening.
    10.No regular antiasthmatic medication except salbutamol inhaler on an “as needed basis” starting from the first screening visit;
    11.Willing to use an approved method of contraception from the time of dose administration and until 90 days after the last dose of study drug.
    E.4Principal exclusion criteria
    1.Worsening of asthma or a respiratory tract infection within 4 weeks of any screening procedure requiring a change in asthma therapy or is deemed clinically significant by the investigator;
    2.History of lifethreatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures or hospitalisation (including emergency room visits) for the treatment of asthma within 3 months of any screening procedure, or have been hospitalized for asthma more than twice in last 12 months;
    3.Pregnant or lactating women.
    4.History of clinically significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness;
    5.History or symptoms of significant neurologic disease, including transient
    ischemic attack (TIA), stroke, seizure disorder, or behavioural disturbances;
    6.Symptomatic with hay fever at screening or predicted to have symptomatic hay fever during the study;
    7.Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; cardiovascular disease, uncontrolled gastrointestinal disease; neurological disease; uncontrolled haematological disease; uncontrolled autoimmune disorders, or other which may impact the feasibility of the results of the study.
    8.Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation;
    9.History of serious adverse reaction, severe hypersensitivity or allergy to any drug or in any other circumstance (e.g. anaphylaxis);
    10.Use of systemic corticosteroids, nebulised bronchodilators, oral beta2agonists 6 weeks prior to study entry;
    11.Use of leukotrienes modifiers, roflumilast, cromoglycate 4 weeks prior to study entry;
    12.Use of long acting 2agonists and/or inhaled corticosteroids (ICS) within 6 months prior to study entry;
    13.Use of short or longacting nonsedative
    antihistamines within 2 or 7 days, respectively, prior to screening until the end of the study;
    14.Chronic use of any other medication for treatment of allergic lung disease other than shortacting bronchodilators taken as needed during the study;
    15.Receipt of an investigational drug treatment within the preceding 30 days, or a longer and more appropriate time as determined by the Investigator
    16.Blood draws of 250 millilitres (mL) or more within 45 days prior to enrolment in the study;
    17.Ongoing use of tobacco products or previous usage within the past 12 months or past history greater than or equal to 5 packyears.
    18.Lung disease other than intermittent or mild to moderate allergic asthma;
    19.Recent (less than 1 year) history of alcohol dependency;
    20.Unwillingness or inability to comply with the study protocol for any other reason;
    E.5 End points
    E.5.1Primary end point(s)
    Late asthmatic response (LAR), defined as the weighted AUC of the FEV1 percent change from post-diluent value from 4 to 10 hours post-allergen challenge (FEV1 AUC0-4h)

    E.5.1.1Timepoint(s) of evaluation of this end point
    until 10 hours after the allergen challenge on Day 9
    E.5.2Secondary end point(s)
    • Early Asthmatic Response (EAR) on Day 9, defined as the weighted AUC of the FEV1 percent changes from post-diluent value from 5 minutes to 2 hours (FEV1 AUC0-2h);
    • Maximum fall in FEV1 during EAR and LAR on Day 9 defined as the maximum decrease in the percent change in FEV1 between 5 minutes and 2 hours post-diluent for EAR and between 4 and 10 hours for LAR;
    • Allergen induced changes in sputum eosinophils and neutrophils (absolute and %) and mediators (ECP, NE, IL-5, IL-8, Eotaxin) at 10 hours post-allergen challenge;
    • Responsiveness to a methacholine (MCh) challenge 24 hours post-AC defined as the provocative MCh challenge concentration causing a 20% decrease in FEV1 (PC20 FEV1).

    - Safety variables (vital signs, ECG, Adverse Events, clinical laboratory values, body mass index)
    - pharmacokinetic parameters (systemic exposure of CHF 6001 and its main inactive metabolite)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - EAR on Day 9
    - Maximum fall in FEV1 during EAR and LAR on Day 9
    - Allergen induced changes at 10 hours post-allergen challenge
    - Responsiveness to a MCh challenge 24 hours post-AC
    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 No
    E.6.11Pharmacogenomic No
    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) 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.8.2.4Number of treatment arms in the trial3
    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 concerned3
    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
    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: 30
    F.1.3Elderly (>=65 years) No
    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 state30
    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 Decision2012-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-10
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