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    Clinical Trial Results:
    Clinical study to investigate safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of multiple doses of the human GATA-3-specific DNAzyme solution SB010 in patients with mild allergic asthma – A randomised, double-blind, parallel, multicentre, phase-IIa study –

    Summary
    EudraCT number
    		 2012-003570-77
    Trial protocol
    		 DE  
    Global end of trial date
    27 Nov 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    24 Mar 2022
    First version publication date
    05 Nov 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of typo for endpoint No. 5.

    Trial information

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    Trial identification
    Sponsor protocol code
    SB010/04/2012
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01743768
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sterna biologicals GmbH & Co KG
    Sponsor organisation address
    Bismarckstraße 7, Marburg, Germany, 35037
    Public contact
    Clinical Trial Manager, Sterna biologicals GmbH & Co. KG , clinicaltrials@sterna-biologicals.com
    Scientific contact
    Clinical Trial Manager, Sterna biologicals GmbH & Co. KG , clinicaltrials@sterna-biologicals.com
    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
    28 Aug 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Evaluate the influence of multiple doses of inhaled SB010 on the late phase response (4 – 7 hours) after allergen challenge (AC). The rationale of the study was to investigate the efficacy, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled SB010 in patients with documented mild allergic asthma. This was done by analysing the late asthmatic response (LAR), following allergen challenge (AC) after a 4-week treatment period. The study consisted of 2 parallel treatment groups and was randomised and placebo-controlled. For an individual patient, the total duration of study participation was estimated at most 149 days. The investigational medicinal product (IMP) SB010 contains the DNAzyme hgd40 (new class of antisense oligonucleotide therapeutics), which targets the mRNA of the transcription factor GATA-3. GATA-3 is the key regulatory factor of T helper cells 2 (Th2)-driven immune responses. Development of asthma is often correlated with a malfunction of immune system.
    Protection of trial subjects
    This trial was conducted in accordance with the ethical principles that have their origin in the currently valid Declaration of Helsinki, and are consistent with ICH-GCP (January 1997) and applicable regulatory requirements. All laboratory tests and procedures used during the study are well established and validated. Adverse events were monitored from the time of signing the informed consent to the end of the study (or study discontinuation).
    Background therapy
    		 -
    Evidence for comparator
    		 Abbreviations used in this entry AC=allergen challenge AUC(4-7) FEV1=Area under the FEV1 curve from 4 h to 7 h AUC(0-12)=The area under the plasma concentration-time curve from zero to 12 h Cmax=Concentration maximum, highest observed plasma concentration of the measured concentration-time profile FEV1=Forced expiratory volume in 1 second FVC=Forced vital capacity h=hour hgd40=Active principle of the IMP SB010, a human GATA-3-specific DNAzyme IMP=Investigational medicinal product LAR=Late asthmatic response OD=Once daily t½=Half-life; Time it takes for the concentration of a substance in the body to be reduced by one half tmax=Time of maximum concentration
    Actual start date of recruitment
    11 Dec 2012
    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
    Germany: 43
    Worldwide total number of subjects
    43
    EEA total number of subjects
    43
    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)
    43
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Overall, 43 adult white male subjects (18 to 60 years) with documented mild asthma ( FEV1 value of FEV1 ≥ 70% of the predicted normal value) were eligible for enrolment into the trial and to randomisation.

    Pre-assignment
    Screening details
    		 Asthma patients were screened according to inclusion and exclusion criteria. Written informed consent was obtained prior to participation in the study. Only patients with a documented or known biphasic reaction to allergen challenge (AC) -- early-phase and late-phase response -- were enrolled; bronchoprovocation at screening was with methacholine.

    Period 1
    Period 1 title
    Overall treatment (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Double-blind design. To ensure double-blinding, the study medications (SB010 and placebo) were identical with respect of their outer appearance, odour, packaging, and labelling.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 SB010
    Arm description
    		 Patients received SB010. Each patient was treated for 28 days once daily (OD) with the test product (10 mg hgd40 in 2 mL solution concentration: 5 mg/mL).
    Arm type
    		 Experimental

    Investigational medicinal product name
    SB010
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    10 mg hgd40 in 2 mL solution (concentration: 5.0 mg/mL), oral inhalation (nebuliser) SB010 (10 mg hgd40 in 2 mL solution as oral inhalation solution (nebuliser) was administered in a dosing interval of 24 h for 28 consecutive days (Day 1 to Day 28) using a controlled inhalation system (AKITA2 APIXNEB®). Inhalations were to be performed in the morning at the same time of the day. On Day 1 (Visit 6, initial IMP), Day 6 ± 1 (Visit 7), Day 13 ± 1 (Visit 8), Day 20 ± 1 (Visit 9), Day 26 ± 1 (Visit 10) and Day 28 (Visit 11, therapy end) trained study personnel supervised the filling of the AKITA2 APIXNEB® nebuliser and the inhalation of the IMP solution by the patient. On the other treatment days patients self-administered the IMP solution once daily via AKITA2 APIXNEB® inhalation device.

    Arm title
    		 Placebo
    Arm description
    		 Patients received Placebo. Each patient received for 28 days once daily (OD) placebo (2 mL phosphate-buffered saline solution).
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo in 2 mL solution, oral inhalation (nebuliser) Placebo treatment (2 mL placebo nebuliser solution (phosphate-buffered saline) was administered in a dosing interval of 24 h for 28 consecutive days (Day 1 to Day 28) using a controlled inhalation system (AKITA2 APIXNEB®). Inhalations were performed in the morning at the same time of the day. On Day 1 (Visit 6, initial IMP), Day 6 ± 1 (Visit 7), Day 13 ± 1 (Visit 8), Day 20 ± 1 (Visit 9), Day 26 ± 1 (Visit 10) and Day 28 (Visit 11, therapy end) trained study personnel supervised the filling of the AKITA2 APIXNEB® nebuliser and the inhalation of the IMP solution by the patient. On the other treatment days patients self-administered the IMP solution once daily via AKITA2 APIXNEB® inhalation device.

    Number of subjects in period 1
    		SB010 Placebo
    Started
    22
    21
    Completed
    21
    20
    Not completed
    1
    1
         Protocol deviation
    1
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    SB010
    Reporting group description
    		 Patients received SB010. Each patient was treated for 28 days once daily (OD) with the test product (10 mg hgd40 in 2 mL solution concentration: 5 mg/mL).

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received Placebo. Each patient received for 28 days once daily (OD) placebo (2 mL phosphate-buffered saline solution).

    Reporting group values
    		 SB010 Placebo Total
    Number of subjects
    		 22 21 43
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 22 21 43
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 33.8 ± 9.4 37.9 ± 12.1 -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0
        Male
    		 22 21 43
    Race
    Units: Subjects
        Caucasian
    		 22 21 43

    End points

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    End points reporting groups
    Reporting group title
    SB010
    Reporting group description
    		 Patients received SB010. Each patient was treated for 28 days once daily (OD) with the test product (10 mg hgd40 in 2 mL solution concentration: 5 mg/mL).

    Reporting group title
    Placebo
    Reporting group description
    		 Patients received Placebo. Each patient received for 28 days once daily (OD) placebo (2 mL phosphate-buffered saline solution).

    Primary: 1_AUC for FEV1 in late phase response (4-7 h) after allergen challenge

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    End point title
    		 1_AUC for FEV1 in late phase response (4-7 h) after allergen challenge
    End point description
    Area under the curve (AUC) for FEV1, expressed as a percentage of the baseline FEV1 during late asthmatic response (4 to 7 h after allergen challenge), after administration of multiple doses of inhaled SB010. Bronchial AC was performed with allergen extracts according to the allergens used for the skin prick test. For an individual patient, the allergen chosen was based on a positive skin prick test. A safe starting concentration for the inhaled aeroallergen was calculated using results of the skin prick dilution test performed at Visit 2 and the methacholine challenge performed at Visit 1. Day -1 (enrolment i.e. before treatment ) Day 28 (treatment end)
    End point type
    Primary
    End point timeframe
    After an allergen challenge (AC) at visit 4 (Day -1, enrolment) and at visit 11 (Day 28, end of the study). Measurement time points for LAR were 4, 5, 6, and 7 hours after AC.
    End point values
    		 SB010 Placebo
    Number of subjects analysed
    21 [1]
    18 [2]
    Units: hour
    arithmetic mean (standard deviation)
        Day -1
    0.664 ± 0.396
    0.592 ± 0.387
        Day 28
    0.440 ± 0.395
    0.600 ± 0.569
    Notes
    [1] - Intention to treat population
    [2] - Intention to treat population
    Statistical analysis title
    		 Analysis of covariance
    Statistical analysis description
    Comparison of AUC4-7FEV1, at visit 11 between the treatment groups by analysis of covariance, with factors treatment and covariate AUC4-7FEV1 , at visit 4, respectively 2.
    Comparison groups
    SB010 v Placebo
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.021
    Method
    		 ANCOVA
    Parameter type
    		 Mean difference of LS means
    Confidence interval
         level
    		 95%

    Secondary: 2_AUC for FEV1 in late phase response (4-7 h) after allergen challenge (Absolute change)

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    End point title
    		 2_AUC for FEV1 in late phase response (4-7 h) after allergen challenge (Absolute change)
    End point description
    AUC for FEV1 in late phase response (4-7 h) after allergen challenge (Absolute change) For details please refer to endpoint #1. The results are expressed as absolute change and are based on the results shown in endpoint #1. The results for absolute change reflect the effect of treatment on the lung function. Negative values imply improvement of lung function (i.e. less pronounced decline of lung function during the time interval from 4 to 7 hours after AC, considering the time of testing before and after treatment with SB010).
    End point type
    Secondary
    End point timeframe
    After an allergen challenge (AC) at visit 4 (Day -1, enrolment) and at visit 11 (Day 28, end of the study). Measurement time points for LAR were 4, 5, 6, and 7 hours after AC.
    End point values
    		 SB010 Placebo
    Number of subjects analysed
    21 [3]
    18 [4]
    Units: hour
        arithmetic mean (standard deviation)
    -0.224 ± 0.277
    0.007 ± 0.308
    Notes
    [3] - Intention to treat population
    [4] - Intention to treat population
    No statistical analyses for this end point

    Secondary: 3_AUC for FEV1 in late phase response (4-7 h) after allergen challenge (Relative change)

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    End point title
    		 3_AUC for FEV1 in late phase response (4-7 h) after allergen challenge (Relative change)
    End point description
    AUC for FEV1 in late phase response (4-7 h) after allergen challenge (Relative change) The results are expressed as percent change and are based on the results shown in endpoint #1. The results for relative change reflect the effect of treatment on the lung function. As shown in the Table below, a negative value implies an improvement of lung function (i.e. less pronounced decline of lung function during the time interval from 4 to 7 hours after AC, considering the time of testing before and after treatment with SB010).
    End point type
    Secondary
    End point timeframe
    After an allergen challenge (AC) at visit 4 (Day -1, enrolment) and at visit 11 (Day 28, end of the study). Measurement time points for LAR were 4, 5, 6, and 7 hours after allergen challenge (AC).
    End point values
    		 SB010 Placebo
    Number of subjects analysed
    21 [5]
    18 [6]
    Units: percent
        number (not applicable)
    -33.7
    1.4
    Notes
    [5] - Intention to treat population A negative value implies an improvement in lung function.
    [6] - Intention to treat population A positive value implies a decline in lung function.
    No statistical analyses for this end point

    Secondary: 4_ Pharmacokinetic variables: maximum plasma concentration (Cmax)

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    End point title
    		 4_ Pharmacokinetic variables: maximum plasma concentration (Cmax) [7]
    End point description
    Pharmacokinetic variables: maximum plasma concentration (Cmax) hgd40 plasma concentrations after first inhalation (Day 1) and last day of treatment i.e. after 28 days of treatment (Day 29). hgd40 is the active principle of the IMP SB010. hgd40 plasma concentrations was determined using a validated method (hybridisation ELISA) to capture the hgd40).
    End point type
    Secondary
    End point timeframe
    First day of treatment (Day 1) and Day 28, of treatment: before treatment 0 min, and after treatment at 5, 10, 15, 20, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 12, 24 h.
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Result values for the placebo arm were not measureable.
    End point values
    		 SB010
    Number of subjects analysed
    22 [8]
    Units: Percent
    geometric mean (confidence interval 95%)
        Day 1
    3.523 (2.229 to 5.566)
        Day 29
    3.867 (2.483 to 6.020)
    Notes
    [8] - Safety analysis set N=21 (Day 1) N=22 (Day 29)
    No statistical analyses for this end point

    Secondary: 5_Pharmacokinetic variables: time to reach maximum plasma concentration (tmax)

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    End point title
    		 5_Pharmacokinetic variables: time to reach maximum plasma concentration (tmax) [9]
    End point description
    Time to reach maximum plasma concentration (tmax) For further details please see endpoint #4.
    End point type
    Secondary
    End point timeframe
    First day of treatment (Day 1) and Day 28 of treatment: before treatment 0 min, and after treatment at 5, 10, 15, 20, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 12, 24 h.
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Result values for the placebo arm were not measureable.
    End point values
    		 SB010
    Number of subjects analysed
    22 [10]
    Units: hour
    median (full range (min-max))
        Day 1
    0.717 (0.33 to 1.00)
        Day 29
    0.492 (0.08 to 1.00)
    Notes
    [10] - Safety analysis set N=21 (Day 1) N=22 (Day 29)
    No statistical analyses for this end point

    Secondary: 6_Pharmacokinetic variable: half-life (t½)

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    End point title
    		 6_Pharmacokinetic variable: half-life (t½) [11]
    End point description
    Half-life (t½). For further details please see endpoint #4
    End point type
    Secondary
    End point timeframe
    First day of treatment (Day 1) and Day 28 of treatment: before treatment 0 min, and after treatment at 5, 10, 15, 20, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 12, 24 h.
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Result values for the placebo arm were not measureable.
    End point values
    		 SB010
    Number of subjects analysed
    16 [12]
    Units: hour
    geometric mean (confidence interval 95%)
        Day 1
    1.431 (1.176 to 1.742)
        Day 29
    1.624 (1.314 to 2.008)
    Notes
    [12] - Safety analysis set N=16 (Day 1) N=15 (Day 29)
    No statistical analyses for this end point

    Secondary: 7_Pharmacokinetic variable: area under the plasma concentration-time curve from zero to 12 h [AUC(0-12)]

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    End point title
    		 7_Pharmacokinetic variable: area under the plasma concentration-time curve from zero to 12 h [AUC(0-12)] [13]
    End point description
    Pharmacokinetic variable: area under the plasma concentration-time curve from zero to 12 h [AUC(0-12)]. For further details please see endpoint #4. AUC(0-12)=The area under the plasma concentration-time curve from zero to 12 h
    End point type
    Secondary
    End point timeframe
    First day of treatment (Day 1) and Day 28 of treatment: before treatment 0 min, and after treatment at 5, 10, 15, 20, 30, 45 min; 1, 1.5, 2, 4, 6, 8, 12, 24 h.
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: Result values for the placebo arm were not measureable.
    End point values
    		 SB010
    Number of subjects analysed
    22 [14]
    Units: ng.h/mL
    geometric mean (confidence interval 95%)
        Day 1
    5.330 (2.851 to 9.965)
        Day 29
    4.992 (2.502 to 9.961)
    Notes
    [14] - Safety analysis set N=21 (Day 1) N=22 (Day 29)
    No statistical analyses for this end point

    Secondary: 8_Spirometry variable -- FEV1 predicted -- from Visit 4 to Visit 11 (Absolute change)

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    End point title
    		 8_Spirometry variable -- FEV1 predicted -- from Visit 4 to Visit 11 (Absolute change)
    End point description
    Spirometry -- FEV1 predicted, from Visit 4 (enrolment) to Visit 11 (last treatment) -- Absolute change AC=Allergen challenge FEV1=Forced expiratory volume in 1 second
    End point type
    Secondary
    End point timeframe
    Before allergen challenge (AC) at visit 4 (Day -1, enrolment) and at visit 11 (Day 28, end of treatment).
    End point values
    		 SB010 Placebo
    Number of subjects analysed
    21 [15]
    19 [16]
    Units: litre(s)
        arithmetic mean (standard deviation)
    -0.001 ± 0.007
    -0.003 ± 0.008
    Notes
    [15] - Intention to treat population
    [16] - Intention to treat population
    No statistical analyses for this end point

    Secondary: 9_Spirometry variable -- FEV1 predicted -- from Visit 4 to Visit 11 (Percent change)

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    End point title
    		 9_Spirometry variable -- FEV1 predicted -- from Visit 4 to Visit 11 (Percent change)
    End point description
    Spirometry -- FEV1 predicted, from Visit 4 to Visit 11 (Percent change). AC=Allergen challenge FEV1=Forced expiratory volume in 1 second
    End point type
    Secondary
    End point timeframe
    Before allergen challenge (AC) at visit 4 (Day -1, enrolment) and at visit 11 (Day 28, end of treatment).
    End point values
    		 SB010 Placebo
    Number of subjects analysed
    21 [17]
    19 [18]
    Units: percent
        arithmetic mean (standard deviation)
    -0.032 ± 0.146
    -0.066 ± 0.205
    Notes
    [17] - Intention to treat population
    [18] - Intention to treat population
    No statistical analyses for this end point

    Secondary: 10_Spirometry variable -- FVC predicted -- from Visit 4 to Visit 11 (Absolute change)

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    End point title
    		 10_Spirometry variable -- FVC predicted -- from Visit 4 to Visit 11 (Absolute change)
    End point description
    Spirometry -- FVC predicted, from Visit 4 to Visit 11 (Absolute change). AC=Allergen challenge FVC=Forced vital capacity
    End point type
    Secondary
    End point timeframe
    Before allergen challenge (AC) at visit 4 (Day -1, enrolment) and at visit 11 (Day 28, end of treatment).
    End point values
    		 SB010 Placebo
    Number of subjects analysed
    21 [19]
    19 [20]
    Units: litre(s)
        arithmetic mean (standard deviation)
    -0.019 ± 0.081
    -0.003 ± 0.009
    Notes
    [19] - Intention to treat population
    [20] - Intention to treat population
    No statistical analyses for this end point

    Secondary: 11_Spirometry variable -- FVC predicted -- from Visit 4 to Visit 11 (Percent change)

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    End point title
    		 11_Spirometry variable -- FVC predicted -- from Visit 4 to Visit 11 (Percent change)
    End point description
    Spirometry -- FVC predicted, from Visit 4 to Visit 11 (Percent change). AC=Allergen challenge FVC=Forced vital capacity
    End point type
    Secondary
    End point timeframe
    Before allergen challenge (AC) at visit 4 (Day -1, enrolment) and at visit 11 (Day 28, end of treatment).
    End point values
    		 SB010 Placebo
    Number of subjects analysed
    21 [21]
    19 [22]
    Units: percent
        arithmetic mean (standard deviation)
    -0.350 ± 1.521
    -0.065 ± 0.194
    Notes
    [21] - Intention to treat population
    [22] - Intention to treat population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events (AE) were monitored from the time of signing the informed consent to the end of the study (or study discontinuation). The study duration was from Day -56 (Screening visit) to Day 88 ± 4 (Follow-up visit).
    Adverse event reporting additional description
    AEs are presented as treatment-emergent adverse events (TEAE), as safety set. No serious TEAE was reported during this study. One non-TEAE serious AE (SAE) occurred about 2 months after the end of treatment period. The SAE was 'detachment of the retina right', with onset 8 weeks after the last dose of study medication; not related to treatment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    15.1
    Reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group title
    SB010
    Reporting group description
    		 -

    Serious adverse events
    		 Placebo SB010
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
    0 / 22 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Placebo SB010
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 21 (38.10%)
    6 / 22 (27.27%)
    Injury, poisoning and procedural complications
    Laceration
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 21 (9.52%)
    2 / 22 (9.09%)
         occurrences all number
    2
    4
    Sciatica
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    3 / 21 (14.29%)
    2 / 22 (9.09%)
         occurrences all number
    3
    2
    Dyspnoea
         subjects affected / exposed
    2 / 21 (9.52%)
    0 / 22 (0.00%)
         occurrences all number
    2
    0
    Oropharyngeal pain
         subjects affected / exposed
    1 / 21 (4.76%)
    1 / 22 (4.55%)
         occurrences all number
    1
    1
    Asthma
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Bronchial obstruction
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Increased upper airway secretion
         subjects affected / exposed
    1 / 21 (4.76%)
    0 / 22 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1
    Infections and infestations
    Herpes simplex
         subjects affected / exposed
    0 / 21 (0.00%)
    1 / 22 (4.55%)
         occurrences all number
    0
    1

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/25981191
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    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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