Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-003012-23
    Sponsor's Protocol Code Number:AQX-1125-200
    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:2011-08-31
    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 number2011-003012-23
    A.3Full title of the trial
    A phase IIa single-centre, randomised, double-blind, placebo-controlled, two-way cross-over allergen challenge study to evaluate the effect of treatment with once daily AQX-1125 on the late asthmatic response (LAR) to Inhaled Allergen Challenge (IAC) in subjects with mild to moderate atopic asthma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase IIa study to evaluate the effect of treatment with once daily AQX-1125 on the late asthmatic response (LAR) to Inhaled Allergen Challenge (IAC) in subjects with mild to moderate atopic asthma.
    A.3.2Name or abbreviated title of the trial where available
    Allergen Challenge Phase IIa Study
    A.4.1Sponsor's protocol code numberAQX-1125-200
    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 SponsorAQUINOX PHARMACEUTICALS INC
    B.1.3.4CountryCanada
    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 supportAquinox Pharmaceuticals Inc
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHeart Lung Centre
    B.5.2Functional name of contact pointDr Brian Leaker
    B.5.3 Address:
    B.5.3.1Street Address20 Queen Anne Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW1G 8HU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number4402070343302
    B.5.6E-mailbrian.leaker@heartlungcentre.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 nameAQX-1125
    D.3.2Product code AQX-1125
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeAQX 1125
    D.3.9.3Other descriptive nameAQX-1125 acetate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 200
    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 placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Mild to moderate 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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of treatment with once daily AQX-1125 on the LAR to IAC in subjects with mild to moderate atopic asthma.
    E.2.2Secondary objectives of the trial
    To compare the differences in leukocytes, eosinophils and other inflammatory markers after 7 days of AQX-1125 treatment versus placebo in subjects with mild to moderate atopic asthma.

    To evaluate the effect of once daily AQX-1125 treatment on the EAR to IAC and total asthmatic response to IAC in subjects with mild to moderate atopic asthma.

    To evaluate the effect of once daily AQX-1125 treatment on lung function measured by FEV1 post IAC.

    To compare differences in leukocytes and inflammatory markers in sputum after 7 days of AQX-1125 treatment versus placebo in subjects with mild to moderate atopic asthma.

    To evaluate the effect of once daily AQX-1125 treatment on bronchial hyper-reactivity as measured by methacholine challenge on Day 7 and on exhaled nitric oxide on Days 6 and 7 in subjects with mild to moderate atopic asthma.

    To evaluate the pharmacokinetics, safety and tolerability of AQX-1125 in subjects with mild to moderate atopic asthma.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Documented history of bronchial asthma, at least 6 months prior to the Screening Visit 1 and treated only with intermittent short-acting β2 agonist therapy, by inhalation.
    2.Pre-bronchodilator FEV1≥70% of predicted at Screening Visit 1.
    3.Demonstration of a positive wheal reaction on skin prick testing at screening, or within 12 months of screening.
    4.Screening IAC demonstrating that the subject experiences both an EAR and an LAR
    5.Methacholine PC20 (The provocation concentration of methacholine causing a 20% fall in FEV1) ≤16 mg/mL at Screening Visit 2.
    6.No history of smoking within 6 months of Screening Visit 1, and with a total pack year history of ≤ 10 pack years.
    7.Be able to give written signed informed consent
    E.4Principal exclusion criteria
    1.Past or present disease which, as judged by the Investigator, may affect the outcome of this study.
    2.Respiratory tract infection or exacerbation of asthma within 4 weeks prior to the first dose of study drug.
    3.Symptomatic allergic rhinitis.
    4.History of life-threatening asthma.
    5.Administration of systemic glucocorticosteroid therapy steroids within 6 weeks or topical or inhaled steroids within 1 month of Screening Visit 1.
    6.Positive drug or alcohol result at Screening Visit 1 or on Day 1 of either treatment period. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and benzodiazepines.
    7.Subject has recently participated in a clinical trial and have received an investigational product
    8.Subject is pregnant, planning to conceive or lactating.
    9.History of being unable to tolerate or complete methacholine or allergen challenge tests.
    10.Subjects, who, on more than 2 occasions, after 2 concurrent administrations of saline during the allergen challenge at screening, had a fall in FEV1 of greater than 10%.
    11.Subject is undergoing allergen desensitisation therapy. History of immunotherapy in the 3 years prior to Screening Visit 1 or concurrently undergoing immunotherapy treatment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the LAR which is defined as the baseline-corrected area under the FEV1 curve from 4 to 10 hours after allergen challenge (AUC4-10h) on Day 6 of each treatment period.
    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 No
    E.6.6Pharmacokinetic Yes
    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 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 trial2
    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
    Last visit of last subject.
    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 months0
    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 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.1.1Number of subjects for this age range: 22
    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: 22
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state22
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-10-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-13
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Mon Apr 29 09:35:02 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA