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    Clinical Trial Results:
    A clinical study to assess the feasibility of measuring inhaled medication concentrations in exhaled breath condensate obtained from healthy volunteers and asthma patients and to assess the relationship with clinical endpoints

    Summary
    EudraCT number
    		 2017-003177-34
    Trial protocol
    		 NL  
    Global end of trial date
    20 Aug 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Feb 2022
    First version publication date
    17 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CHDR1722
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Centre for Human Drug Research
    Sponsor organisation address
    Zernikedreef 8, Leiden, Netherlands, 2333CL
    Public contact
    Principal Investigator, Centre for Human Drug Research, +31 715246400, clintrials@chdr.nl
    Scientific contact
    Principal Investigator, Centre for Human Drug Research, +31 715246400, clintrials@chdr.nl
    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
    20 Aug 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Aug 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Aug 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary objectives: • To identify whether EBC can be used as a non-invasive method to measure the PK of salbutamol and tobramycin. • To determine whether the relationship in mild-moderate asthmatics between pulmonary lung function parameters and salbutamol concentrations can be better described by concentrations in the EBC compared to plasma.
    Protection of trial subjects
    Screening of 12 healthy male volunteers. Measurements: ECG, vitals, pulmonary function tests and bloodsamples for hematological and chemical analysis.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    04 Dec 2017
    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
    Netherlands: 12
    Worldwide total number of subjects
    12
    EEA total number of subjects
    12
    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)
    12
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment overall studyperiod

    Pre-assignment
    Screening details
    		 12 healthy male subjects, eligible according to in- and exclusion criteria after screening.

    Period 1
    Period 1 title
    Overall studyperiod (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Salbutamol intravenous
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A total dose of 250 microgram salbutamol (5 ml of 50mcg/ml) will be injected slowly i.v.in 1-10 minutes.

    Arm title
    		 Salbutamol inhaled
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Salbutamol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    A total dose of 400 microgram will be administered using the Volumatic®device.

    Arm title
    		 Tobramycin intravenous
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tobramycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous drip use
    Dosage and administration details
    A total dose of 1mg/kg tobramycin will be administered i.v.. For this purpose the required dose of tobramycin 40 mg/ml will be solved in 50-100ml 0.9% Natriumchloride infusion fluid. The infusion will be administered in 30 minutes. For subjects with a BMI >25the dose will be adjusted for body composition following the following formula: Dosing weight = Ideal body weight + 0.40 * (Actual body weight –Ideal body weight). Ideal body weight = length (in meters) * length (in meters) * 25.

    Arm title
    		 Tobramycin inhaled
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tobramycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    A total dose of 170 mg tobramycin will be administered by inhalation using the Medix AC2000®nebulizerof Clement Clarke International.

    Number of subjects in period 1
    		Salbutamol intravenous Salbutamol inhaled Tobramycin intravenous Tobramycin inhaled
    Started
    12
    12
    12
    12
    Completed
    12
    12
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall studyperiod
    Reporting group description
    		 -

    Reporting group values
    		 Overall studyperiod Total
    Number of subjects
    		 12 12
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 12
    Gender categorical
    Units: Subjects
        Male
    		 12 12

    End points

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    End points reporting groups
    Reporting group title
    Salbutamol intravenous
    Reporting group description
    		 -

    Reporting group title
    Salbutamol inhaled
    Reporting group description
    		 -

    Reporting group title
    Tobramycin intravenous
    Reporting group description
    		 -

    Reporting group title
    Tobramycin inhaled
    Reporting group description
    		 -

    Primary: Treatment-emergent serious adverse events (SAEs)

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    End point title
    		 Treatment-emergent serious adverse events (SAEs) [1]
    End point description
    End point type
    Primary
    End point timeframe
    Overall studyperiod
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As this was an exploratory study, no formal power analysis was performed. Pharmacokinetic endpoints were summarized descriptively. Please refer to uploaded article.
    End point values
    		 Salbutamol intravenous Salbutamol inhaled Tobramycin intravenous Tobramycin inhaled
    Number of subjects analysed
    12
    12
    12
    12
    Units: Number
    0
    0
    0
    0
    Attachments
    		 Report
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Overall study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Studygroup
    Reporting group description
    		 -

    Serious adverse events
    		 Studygroup
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Studygroup
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 12 (100.00%)
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    10 / 12 (83.33%)
         occurrences all number
    10
    Dizziness
         subjects affected / exposed
    2 / 12 (16.67%)
         occurrences all number
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    General disorders and administration site conditions
    Influenza like illness
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Feeling abnormal
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Feeling hot
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    1 / 12 (8.33%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    13 Mar 2018
    The change in this amendment covers the addition of two PK and EBC samples to the protoco
    08 May 2018
    additional spirometry measurements with a new spirometrydevice, which we want to validate during stage 2 of the study.
    28 May 2018
    -The upper limit for age is increased to 65 years; - The upper limit for BMI is increased to 35 kg/m2; - The minimum period subjects have to be off corticosteroid inhalation therapy has been reduced to threeweeks; and, - For the lung function a post-bronchodilator for FEVI > 70% of predicted will be used instead of pre-bronchodilator FEVr > 70% of predicted. As all asthma subjects will receive salbutamol, either inhaled orintravenously at the start of each the study days, a post bronchodilator lung function is more relevant. lnaddition, exhaled breath condensate sampling involves tidal breathing and is not associated withbronchoconstriction (Baraldi, 2003) .

    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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