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    Clinical Trial Results:
    A comparison of Symbicort Single inhaler Therapy (Symbicort Turbohaler 160/4.5 μg, 1 inhalation b.i.d. plus as needed) and conventional best practice for the treatment of persistent asthma in adolescents and adults - a 26-week, randomised, open-label, parallel-group, multi-centre study (SALTO)

    Summary
    EudraCT number
    		 2004-001107-36
    Trial protocol
    		 BE  
    Global end of trial date
    20 Jun 2008

    Results information
    Results version number
    		 v2(current)
    This version publication date
    08 Jul 2016
    First version publication date
    28 Apr 2016
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    D5890L00009
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    AstraZeneca
    Sponsor organisation address
    AstraZeneca NV/SA, B-1180 Brussels, Belgium,
    Public contact
    Guy Vandenhoven MD, AstraZeneca, ClinicalTrialTransparency@astrazeneca.com
    Scientific contact
    Guy Vandenhoven MD, AstraZeneca, ClinicalTrialTransparency@astrazeneca.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
    20 Jun 2008
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Jun 2008
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Jun 2008
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to compare the efficacy of SMART (Symbicort Turbohaler160/4.5μg, 1 inhalation b.i.d. + as needed in response to symptoms) with treatment according to conventional best practice in adolescent and adult patients with persistent asthma. The primary efficacy variable was the time to first severe asthma exacerbation.
    Protection of trial subjects
    The final study protocol, including the final version of the Informed Consent Form, was approved or given a favourable opinion in writing by an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) as appropriate. The investigator submitted written approval to AstraZeneca NV/SA before enrolling any patient into the study. The principal investigator(s) at each centre ensured that the patient was given full and adequate oral and written information about the nature, purpose, possible risk and benefit of the study. Patients were also notified that they were free to discontinue from the study at any time. The patients were given the opportunity to ask questions and allowed time to consider the information provided. In patients below the age of consent, informed consent was obtained from both the patient and the patient’s parent/legal guardian. The patient’s signed and dated informed consent was obtained before conducting any study-specific procedure
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2004
    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
    Belgium: 912
    Worldwide total number of subjects
    912
    EEA total number of subjects
    912
    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)
    64
    Adults (18-64 years)
    724
    From 65 to 84 years
    122
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study consisted of 912 randomised patients from Belgium between December 2004 and January 2006.

    Pre-assignment
    Screening details
    		 The study consisted of five scheduled visits to the clinic: at the start of the run-in period, at randomisation to the treatment groups and after 4, 13 and 26 weeks of study. Patients were allocated to one of 2 treatment groups in a random manner.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Symbicort SMART
    Arm description
    		 Symbicort Turbohaler 160/4.5 μg, 1 inhalation b.i.d. plus as needed
    Arm type
    		 Experimental

    Investigational medicinal product name
    Symbicort Turbohaler: budesonide 160 μg/inhalation (delivered dose) and formoterol fumarate dehydrate 4.5 μg/inhalation (delivered dose)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    160/4.5 μg, 1 inhalation b.i.d. plus as needed

    Arm title
    		 Conventional Best Practice (CBP)
    Arm description
    		 Conventional Best Practice
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Symbicort SMART Conventional Best Practice (CBP)
    Started
    452
    460
    Completed
    423
    444
    Not completed
    29
    16
         Consent withdrawn by subject
    4
    1
         Adverse event, non-fatal
    4
    2
         Other
    4
    1
         Lost to follow-up
    5
    3
         Protocol deviation
    12
    9

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Symbicort SMART
    Reporting group description
    		 Symbicort Turbohaler 160/4.5 μg, 1 inhalation b.i.d. plus as needed

    Reporting group title
    Conventional Best Practice (CBP)
    Reporting group description
    		 Conventional Best Practice

    Reporting group values
    		 Symbicort SMART Conventional Best Practice (CBP) Total
    Number of subjects
    		 452 460 912
    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)
    		 32 32 64
        Adults (18-64 years)
    		 358 366 724
        From 65-84 years
    		 61 61 122
        85 years and over
    		 1 1 2
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 43.4 (12 to 87) 42.9 (13 to 85) -
    Gender categorical
    Units: Subjects
        Female
    		 253 271 524
        Male
    		 199 189 388
    Median time since diagnosis
    Units: years
        median (full range (min-max))
    		 21 (0 to 86) 20.3 (0 to 78) -

    End points

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    End points reporting groups
    Reporting group title
    Symbicort SMART
    Reporting group description
    		 Symbicort Turbohaler 160/4.5 μg, 1 inhalation b.i.d. plus as needed

    Reporting group title
    Conventional Best Practice (CBP)
    Reporting group description
    		 Conventional Best Practice

    Primary: No of patients with severe exacerbations

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    End point title
    		 No of patients with severe exacerbations
    End point description
    End point type
    Primary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Conventional Best Practice (CBP)
    Number of subjects analysed
    452
    460
    Units: patients
    12
    19
    Statistical analysis title
    		 Time to first severe Exacerbation
    Comparison groups
    Conventional Best Practice (CBP) v Symbicort SMART
    Number of subjects included in analysis
    912
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.2347
    Method
    		 Regression, Cox
    Parameter type
    		 Hazard ratio (HR)
    Point estimate
    0.645
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.313
         upper limit
    		 1.329

    Secondary: Number of severe exacerbations

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    End point title
    		 Number of severe exacerbations
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Conventional Best Practice (CBP)
    Number of subjects analysed
    452
    460
    Units: patients with exacerbations
        No, of patients with 1 event
    10
    15
        No, of patients with 2 events
    2
    3
        No, of patients with 3 events
    0
    0
        No, of patients with >3 events
    0
    1
    Statistical analysis title
    		 Mean number of severe asthma exacerbations
    Comparison groups
    Symbicort SMART v Conventional Best Practice (CBP)
    Number of subjects included in analysis
    912
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0029
    Method
    		 Poisson Regression
    Parameter type
    		 Risk ratio (RR)
    Point estimate
    0.5754
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.4
         upper limit
    		 0.83

    Secondary: Average number of inhalations per day

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    End point title
    		 Average number of inhalations per day
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Conventional Best Practice (CBP)
    Number of subjects analysed
    445
    457
    Units: average inhalations per day
        arithmetic mean (full range (min-max))
    0.93 (0 to 6.95)
    0.99 (0 to 10.4)
    Statistical analysis title
    		 Average no of inhalations per day
    Comparison groups
    Symbicort SMART v Conventional Best Practice (CBP)
    Number of subjects included in analysis
    902
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1471
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.24
         upper limit
    		 0.04

    Secondary: As needed free-days

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    End point title
    		 As needed free-days
    End point description
    Percentage of days without medication use during the treatment period.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Conventional Best Practice (CBP)
    Number of subjects analysed
    445
    457
    Units: Percentage use
        arithmetic mean (full range (min-max))
    60.5 (0 to 102.4)
    62.4 (0 to 114.3)
    Statistical analysis title
    		 As needed free-days
    Statistical analysis description
    Percentage of as needed medication free days in the treatment period
    Comparison groups
    Symbicort SMART v Conventional Best Practice (CBP)
    Number of subjects included in analysis
    902
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5108
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -4.77
         upper limit
    		 2.38

    Secondary: Mean daily dose of inhaled steroids

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    End point title
    		 Mean daily dose of inhaled steroids
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Conventional Best Practice (CBP)
    Number of subjects analysed
    452
    460
    Units: μg
        arithmetic mean (full range (min-max))
    482 (329 to 1473)
    589 (247 to 2000)
    Statistical analysis title
    		 Mean daily dose of inhaled steroids
    Comparison groups
    Symbicort SMART v Conventional Best Practice (CBP)
    Number of subjects included in analysis
    912
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.0001
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -107.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -141.2
         upper limit
    		 -73.76

    Secondary: PEF pre-BD at end of treatment

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    End point title
    		 PEF pre-BD at end of treatment
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Conventional Best Practice (CBP)
    Number of subjects analysed
    452
    460
    Units: L/min
        arithmetic mean (full range (min-max))
    423.72 (85 to 748)
    417.84 (60 to 763)
    Statistical analysis title
    		 PEF pre-BD at end of treatment
    Comparison groups
    Symbicort SMART v Conventional Best Practice (CBP)
    Number of subjects included in analysis
    912
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5991
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    2.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.81
         upper limit
    		 10.07

    Secondary: PEF post-BD at end of treatment

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    End point title
    		 PEF post-BD at end of treatment
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Conventional Best Practice (CBP)
    Number of subjects analysed
    452
    460
    Units: L/min
        arithmetic mean (full range (min-max))
    446.36 (100 to 770)
    442.83 (100 to 804)
    Statistical analysis title
    		 PEF post-BD at end of treatment
    Comparison groups
    Symbicort SMART v Conventional Best Practice (CBP)
    Number of subjects included in analysis
    912
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.6537
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    1.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -5.65
         upper limit
    		 9

    Secondary: FEV1 pre-BD at end of treatment

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    End point title
    		 FEV1 pre-BD at end of treatment
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Conventional Best Practice (CBP)
    Number of subjects analysed
    137
    136
    Units: L/min
        arithmetic mean (full range (min-max))
    2.76 (0.9 to 6.2)
    2.87 (0.7 to 6)
    Statistical analysis title
    		 FEV1 pre-BD at end of treatment
    Comparison groups
    Symbicort SMART v Conventional Best Practice (CBP)
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.4135
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.004
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.05

    Secondary: FEV1 post-BD at end of treatment

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    End point title
    		 FEV1 post-BD at end of treatment
    End point description
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Conventional Best Practice (CBP)
    Number of subjects analysed
    137
    136
    Units: L/min
        arithmetic mean (full range (min-max))
    2.91 (0.9 to 6.3)
    3 (0.8 to 6)
    Statistical analysis title
    		 FEV1 post-BD at end of treatment
    Comparison groups
    Symbicort SMART v Conventional Best Practice (CBP)
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3285
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.004
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.12
         upper limit
    		 0.03

    Secondary: Mean overall ACQ score

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    End point title
    		 Mean overall ACQ score
    End point description
    Mean ACQ score (overall) during the treatment period
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Conventional Best Practice (CBP)
    Number of subjects analysed
    446
    451
    Units: mean score
        arithmetic mean (full range (min-max))
    1.1 (0 to 4.2)
    1.16 (0 to 5.2)
    Statistical analysis title
    		 Change in ACQ score
    Statistical analysis description
    Change in mean ACQ score (overall) during the treatment period
    Comparison groups
    Symbicort SMART v Conventional Best Practice (CBP)
    Number of subjects included in analysis
    897
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.0026
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.2
         upper limit
    		 -0.04

    Secondary: Mean overall SATQ score

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    End point title
    		 Mean overall SATQ score
    End point description
    Satisfaction with Asthma Treatment Questionnaire (SATQ) : to measure patients satisfaction with their inhaled asthma medication. It consists of 26 questions on a 7 point scale within 4 domains (effectiveness, ease of use, burden of asthma medication, side effects and worries). Higher scores indicates satisfaction with inhaled asthma medication.
    End point type
    Secondary
    End point timeframe
    26 weeks
    End point values
    		 Symbicort SMART Conventional Best Practice (CBP)
    Number of subjects analysed
    421
    421
    Units: mean score
        arithmetic mean (full range (min-max))
    4.81 (3.1 to 6.3)
    4.82 (3.4 to 6.6)
    Statistical analysis title
    		 Change in SATQ score
    Comparison groups
    Symbicort SMART v Conventional Best Practice (CBP)
    Number of subjects included in analysis
    842
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.5039
    Method
    		 ANOVA
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.08
         upper limit
    		 0.04

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Only information regarding SAEs, and discontinuations due to AE was collected, from the run-in period until visit 5 (26 weeks after randomisation).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    7.0
    Reporting groups
    Reporting group title
    Conventional Best Practice (CBP)
    Reporting group description
    		 Conventional Best Practice

    Reporting group title
    Symbicort SMART
    Reporting group description
    		 Symbicort Turbohaler 160/4.5 μg, 1 inhalation b.i.d. plus as needed

    Serious adverse events
    		 Conventional Best Practice (CBP) Symbicort SMART
    Total subjects affected by serious adverse events
         subjects affected / exposed
    12 / 460 (2.61%)
    10 / 452 (2.21%)
         number of deaths (all causes)
    0
    2
         number of deaths resulting from adverse events
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Breast Cancer
         subjects affected / exposed
    1 / 460 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Myelodysplastic Syndrome
         subjects affected / exposed
    0 / 460 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine Leiomyoma
         subjects affected / exposed
    1 / 460 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Transient Ischaemic Attack
         subjects affected / exposed
    1 / 460 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Completed suicide
         subjects affected / exposed
    0 / 460 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Immune system disorders
    Asthma
         subjects affected / exposed
    1 / 460 (0.22%)
    2 / 452 (0.44%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Salpingitis
         subjects affected / exposed
    1 / 460 (0.22%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Benign Prostatic Hyperplasia
         subjects affected / exposed
    1 / 460 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Tonsillitis
         subjects affected / exposed
    0 / 460 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Myocardial Infarction
         subjects affected / exposed
    1 / 460 (0.22%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Nervous system disorders
    Cerebrovascular Accident
         subjects affected / exposed
    1 / 460 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Facial Palsy
         subjects affected / exposed
    0 / 460 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Ear and labyrinth disorders
    Labyrinthine Fistula
         subjects affected / exposed
    1 / 460 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Gastric Ulcer
         subjects affected / exposed
    0 / 460 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis
         subjects affected / exposed
    2 / 460 (0.43%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Urethral Meatus Stenosis
         subjects affected / exposed
    1 / 460 (0.22%)
    0 / 452 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Intervertebral Disc Protusion
         subjects affected / exposed
    0 / 460 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    0 / 460 (0.00%)
    1 / 452 (0.22%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Conventional Best Practice (CBP) Symbicort SMART
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 460 (0.22%)
    1 / 452 (0.22%)
    Cardiac disorders
    Dyspnoea
         subjects affected / exposed
    0 / 460 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Nervous system disorders
    Paraesthesia
         subjects affected / exposed
    0 / 460 (0.00%)
    1 / 452 (0.22%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Pharyngolaryngeal Pain
         subjects affected / exposed
    1 / 460 (0.22%)
    0 / 452 (0.00%)
         occurrences all number
    1
    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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    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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