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    Clinical Trial Results:
    A Double-Blind, Randomised, Placebo-controlled, Cross-over, Phase 2 Mannitol Challenge Study, Investigating the Efficacy of CRD007 in Adult Subjects with Asthma

    Summary
    EudraCT number
    		 2015-000120-28
    Trial protocol
    		 DK  
    Global end of trial date
    02 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Jul 2017
    First version publication date
    08 Jul 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    RSPR-007
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02609334
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    RSPR Pharma AB
    Sponsor organisation address
    Kornhamnstorg 53, Stockholm, Sweden, SE-111
    Public contact
    Carl-Johan Dalsgaard, Chief Executive Officer, RSPR Pharma AB, 46 709759863, carl-johan.dalsgaard@ofco.se
    Scientific contact
    Carl-Johan Dalsgaard, Chief Executive Officer, RSPR Pharma AB, 46 709759863, carl-johan.dalsgaard@ofco.se
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    03 Sep 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficacy of single doses of 40 mg and 400 mg CRD007 in subjects with asthma
    Protection of trial subjects
    AEs were reported in the period from the subject signed the informed consent form until the end of trial participation (Visit 5). At each visit, the subject was asked about AEs in an objective manner, e.g.: “Have you experienced any problems since the last visit?” and was followed by safety laboratory sampling.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Mar 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The patients were recruited at two trial sites in Denmark. First patient first visit (FPFV) took place on 26-Mar-2015 and Last patient last visit (LPLV) took place on 02-Jul-2015

    Pre-assignment
    Screening details
    		 A total of 83 subjects were screened in order to randomise 24 subjects. 57 subjects were screening failures and 2 subjects did not wish to continue to randomisation. At the screening visit, the subject was assigned a screening number and evaluated for eligibility according to the eligibility criteria (in- and exclusion criteria)

    Pre-assignment period milestones
    Number of subjects started
    		 24
    Number of subjects completed
    		 24

    Period 1
    Period 1 title
    Mannitol testing (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Arm title
    		 Mannitol test crossover trial
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    CRD007
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Low dose CRD007, High dose CRD007 and placebo

    Number of subjects in period 1
    		Mannitol test crossover trial
    Started
    24
    Low dose
    24
    High dose
    24
    Placebo
    24
    Completed
    24

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Mannitol testing
    Reporting group description
    		 -

    Reporting group values
    		 Mannitol testing Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 24 24
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 13 13
    Subject analysis sets

    Subject analysis set title
    Low dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Low dose CRD007

    Subject analysis set title
    High dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    High dose CRD007

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo

    Subject analysis sets values
    		 Low dose High dose Placebo
    Number of subjects
    24
    24
    23
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
        Adults (18-64 years)
    24
    24
    23
        From 65-84 years
    0
    0
    0
        85 years and over
    0
    0
    0
    Age continuous
    Units:
        
    ±
    ±
    ±
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    Mannitol test crossover trial
    Reporting group description
    		 -

    Subject analysis set title
    Low dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Low dose CRD007

    Subject analysis set title
    High dose
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    High dose CRD007

    Subject analysis set title
    Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Placebo

    Primary: PD15 for mannitol after treatment with CRD007 and placebo

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    End point title
    		 PD15 for mannitol after treatment with CRD007 and placebo
    End point description
    End point type
    Primary
    End point timeframe
    At least 2 repeatable FEV1 manoeuvers were performed 60 seconds after each dose and the highest FEV1 was used in the calculation.
    End point values
    		 Mannitol test crossover trial Low dose High dose Placebo
    Number of subjects analysed
    24
    24
    24
    23
    Units: mg
        median (full range (min-max))
    158.4 (27.4 to 309)
    305.4 (45.9 to 795)
    256.7 (11.5 to 795)
    234.6 (12.7 to 795)
    Statistical analysis title
    		 Analysis of variance
    Statistical analysis description
    With a two-sided test at a 5% significance level, 24 evaluable subjects provide an 80% chance to detect a true PD15 ratio between any two treatments of 1.5. PD15 mannitol was determined by linear interpolation on the log dose scale. PD15 mannitol was compared between the 3 treatments (placebo, CRD007 40 mg and CRD007 400 mg) using an analysis of variance model with fixed factors treatment, period and patient. The analysis was conducted on logged values and the result subsequently transformed ba
    Comparison groups
    Mannitol test crossover trial v High dose v Low dose v Placebo
    Number of subjects included in analysis
    95
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 5
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All events meeting the definition of an AE were to be reported in the period from the subject has signed the informed consent form until the end of trial participation (Visit 5).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18
    Reporting groups
    Reporting group title
    High dose
    Reporting group description
    		 -

    Reporting group title
    Low dose
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Serious adverse events
    		 High dose Low dose Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 23 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 High dose Low dose Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 23 (4.35%)
    Investigations
    Blood bilirubin abnormal
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 23 (4.35%)
         occurrences all number
    0
    0
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 23 (0.00%)
         occurrences all number
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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.

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