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    Clinical Trial Results:
    Double-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis

    Summary
    EudraCT number
    		 2014-001484-12
    Trial protocol
    		 DE   BE   ES   NL  
    Global end of trial date
    04 Oct 2016

    Results information
    Results version number
    		 v2(current)
    This version publication date
    07 Aug 2019
    First version publication date
    26 Aug 2017
    Other versions
    		 v1
    Version creation reason
    • Changes to summary attachments
    Full paper
    Summary report(s)
    		 Full paper

    Trial information

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    Trial identification
    Sponsor protocol code
    BUL-1/EEA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02434029
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 EOS-1: Acronym
    Sponsors
    Sponsor organisation name
    Dr Falk Pharma GmbH
    Sponsor organisation address
    Leinenweberstrasse 5, Freiburg, Germany, 79108
    Public contact
    Department of Medical Science, Dr Falk Pharma GmbH, +49 761-1514-0,
    Scientific contact
    Department of Medical Science, Dr Falk Pharma GmbH, +49 761-1514-0,
    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
    22 Feb 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Oct 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of budesonide effervescent tablets for orodispersible use vs. placebo for the induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis (EoE).
    Protection of trial subjects
    Prior to recruitment of patients, all relevant documents of the clinical study were submitted and approved by the Independent Ethics Committees (IECs) responsible for the participating investigators. Written consent documents embodied the elements of informed consent as described in the Declaration of Helsinki, the ICH Guidelines for Good Clinical Practice (GCP) and were in accordance with all applicable laws and regulations. The informed consent form and patient information sheet described the planned and permitted uses, transfers and disclosures of the patient’s personal data and personal health information for purposes of conducting the study. The informed consent form and the patient information sheet further explained the nature of the study, its objectives and potential risks and benefits as well as the date informed consent was given. Before being enrolled in the clinical trial, every patient was informed that participation in this trial was voluntary and that he/she could withdraw from the study at any time without giving a reason and without having to fear any loss in his/her medical care. The patient’s consent was obtained in writing before the start of the study. By signing the informed consent, the patient declared that he/she was participating voluntarily and intended to follow the study protocol instructions and the instructions of the investigator and to answer the questions asked during the course of the trial. For endoscopy and biopsy sampling to be performed for confirmation of diagnosis of eosinophilic esophagitis by the central pathologist, the patients received the standard preparation for sedation during the endoscopy as routinely performed at the study sites.
    Background therapy
    		 No concomitant background therapy, except stable diets and/or stable treatment with protonpump-inhibitors was allowed during the trial.
    Evidence for comparator
    		 Using a placebo arm in this clinical trial was ethically justified as there were compelling and scientifically sound methodological reasons for the use of a placebo control in this trial, since there were no comparator products with a marketing authorization for the treatment of EoE available. Moreover, the use of a placebo group was also justified, as it allowed to control for all other potential influences on the actual or apparent course of the disease other than those arising from the pharmacological action of budesonide (including but not limited to influences such as, spontaneous change in the disease, subject and investigator expectations, the effect of participating in this trial, or subjective elements of diagnosis or assessments), as stated in the “ICH Topic E10: Note for guidance on choice of control group in clinical trials” (CPMP/ICH/364/96).
    Actual start date of recruitment
    11 Nov 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 3
    Country: Number of subjects enrolled
    Spain: 34
    Country: Number of subjects enrolled
    Germany: 43
    Country: Number of subjects enrolled
    Switzerland: 8
    Worldwide total number of subjects
    88
    EEA total number of subjects
    80
    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)
    86
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 In total, 19 centers randomized patients: 10 centers in Germany (DE), 6 centers in Spain (ES), 2 centers in Switzerland (CH), and 1 center in The Netherlands (NL). First patient was screened (entered) at the 11Nov2015. Last patient completed his last visit at 04Oct2016

    Pre-assignment
    Screening details
    		 126 patients were screened to fullfill the In-/Exclusion criteria. Of them, 88 patients were randomized and treated with budesonide or placebo.

    Pre-assignment period milestones
    Number of subjects started
    		 126 [1]
    Number of subjects completed
    		 88

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Protocol deviation: 38
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Of the 126 patients screened within the pre-assignment period, 38 patients did not fulfill the in-/exclusion criteria and therefore, were not randomized and did not enter the double-blind treatment period.
    Period 1
    Period 1 title
    Double-blind 6-week treatment phase (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
    The appearance and taste of the placebo effervescent tablet for orodispersible use was indistinguishable from the verum effervescent tablet for orodispersible use.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Budesonide 1mg BID
    Arm description
    		 Twice daily 1mg budesonide
    Arm type
    		 Experimental

    Investigational medicinal product name
    1mg budesonide effervescent tablet for orodispersible use
    Investigational medicinal product code
    BUET 1mg
    Other name
    Budesonide 1mg orodispersible tablet
    Pharmaceutical forms
    Effervescent tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Take one effervescent tablet each in the morning and in the evening after the meal. The effervescent tablet has to be placed on the tongue which allows rapid disintegration. The effervescent tablet dissolves rapidly and will be swallowed with saliva little by little. Do not drink or eat during 30 minutes after study drug administration.

    Arm title
    		 Placebo BID
    Arm description
    		 Twice daily Placebo
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo effervescent tablet for orodispersible use
    Investigational medicinal product code
    Placebo
    Other name
    Placebo orodispersible tablet
    Pharmaceutical forms
    Effervescent tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Take one effervescent tablet each in the morning and in the evening after the meal. The effervescent tablet has to be placed on the tongue which allows rapid disintegration. The effervescent tablet dissolves rapidly and will be swallowed with saliva little by little. Do not drink or eat during 30 minutes after study drug administration.

    Number of subjects in period 1
    		Budesonide 1mg BID Placebo BID
    Started
    59
    29
    Completed
    56
    25
    Not completed
    3
    4
         Lack of efficacy
    3
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Budesonide 1mg BID
    Reporting group description
    		 Twice daily 1mg budesonide

    Reporting group title
    Placebo BID
    Reporting group description
    		 Twice daily Placebo

    Reporting group values
    		 Budesonide 1mg BID Placebo BID Total
    Number of subjects
    		 59 29 88
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 57 29 86
        From 65-84 years
    		 2 0 2
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 37 ( 11.5 ) 36.9 ( 9.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 11 4 15
        Male
    		 48 25 73
    Ethnic Group
    Units: Subjects
        White
    		 59 29 88
    Previous esophageal dilation
    Units: Subjects
        yes
    		 9 5 14
        no
    		 50 24 74
    Previous PPI trial conducted
    Units: Subjects
        yes
    		 59 29 88
    History of allergic disease
    Units: Subjects
        yes
    		 47 23 70
        no
    		 12 6 18
    Endoscopic disease activity
    Units: Subjects
        none
    		 1 0 1
        mild
    		 9 3 12
        moderate
    		 30 17 47
        severe
    		 19 9 28
    Duration since first symptoms
    Units: months
        arithmetic mean (standard deviation)
    		 134 ( 104.6 ) 139 ( 98.8 ) -
    Duration since diagnosis
    Units: months
        arithmetic mean (standard deviation)
    		 48.8 ( 44.3 ) 57.6 ( 49.3 ) -
    Overall peak eos/mm2 hpf
    Units: eos/mm2 hpf
        arithmetic mean (standard deviation)
    		 242 ( 140.7 ) 239 ( 125 ) -
    Total Modified EEsAI Endoscopic Score (range: 0-9)
    Worst case assessment from all parts of the esophagus
    Units: points
        arithmetic mean (standard deviation)
    		 3.8 ( 1.46 ) 4.6 ( 1.32 ) -
    'Inflammatory signs' subscore - Modified EEsAI Endoscopic Score (range: 0-4)
    Worst case assessment from all parts of the esophagus
    Units: points
        arithmetic mean (standard deviation)
    		 2.7 ( 0.96 ) 3 ( 0.98 ) -
    'Fibrotic signs' subscore - Modified EEsAI Endoscopic Score (range: 0-4)
    Worst case assessment from all parts of the esophagus
    Units: points
        arithmetic mean (standard deviation)
    		 1 ( 1 ) 1.4 ( 0.91 ) -
    Dysphagia Numerical Rating Scale [NRS] (0-10)
    0 = no troubles to swallow 10 = most severe troubles to swallow
    Units: points
        arithmetic mean (standard deviation)
    		 5.8 ( 2.02 ) 5.9 ( 1.69 ) -
    Pain during swallowing NRS (0-10)
    0 = no pain during swallowing 10 = most severe pain during swallowing
    Units: points
        arithmetic mean (standard deviation)
    		 3.5 ( 2.78 ) 3.4 ( 3.17 ) -
    Patient’s Global Assessment of EoE activity (NRS 0-10)
    0 = no symptoms 10 = most severe symptoms
    Units: points
        arithmetic mean (standard deviation)
    		 5.9 ( 1.5 ) 6 ( 1.5 ) -
    Physician’s Global Assessment of EoE activity (NRS 0-10)
    considered all findings concerning the severity of the patient’s EoE (clinical, endoscopic, histologic) 0 = inactive EoE 10 = most active EoE
    Units: points
        arithmetic mean (standard deviation)
    		 6.1 ( 1.3 ) 6.2 ( 1.3 ) -
    Total weekly EEsAI-PRO (0-100)
    Eosinophilic Esophagitis Activity Index Patient Reported Outcome (EEsAI-PRO) score: The relevant items for the EEsAI-PRO Score were: - Frequency of trouble swallowing (with 4 increments ranging from never to daily) - Duration of dysphagia episodes (≤ 5 / > 5 minutes) - Presence / absence of pain during swallowing - Visual Dysphagia Questions (VDQ) on 8 foods of 8 different consistencies (hypothetical test meal; grades 0 to 3) resulting in a VDQ score - Behavioural change strategies on specific foods with 8 different consistencies: Range: 0 (no EoE activity) to 100 (most severe EoE)
    Units: points
        arithmetic mean (standard deviation)
    		 54.1 ( 15.5 ) 55.3 ( 15.8 ) -

    End points

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    End points reporting groups
    Reporting group title
    Budesonide 1mg BID
    Reporting group description
    		 Twice daily 1mg budesonide

    Reporting group title
    Placebo BID
    Reporting group description
    		 Twice daily Placebo

    Primary: Number (%) of patients with clinico-pathological remission at week 6 (LOCF) of double-blind phase

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    End point title
    		 Number (%) of patients with clinico-pathological remission at week 6 (LOCF) of double-blind phase
    End point description
    Rate of patients with clinico-pathological remission at week 6 (LOCF) DB defined as fulfilling both criteria: - Histological remission, i.e., peak of <16 eos/mm2 hpf at week 6 (LOCF), AND - Resolution of symptoms (i.e., no or only minimal problems) defined as a severity of ≤2 points on 0 to 10-point (0-10) NRS for dysphagia AND a severity of ≤2 points on 0-10 NRS for pain during swallowing on each day in the week prior to week 6 (LOCF). Patients experiencing a food impaction at any time during the DB-treatment phase which needed endoscopic intervention or who needed an endoscopic dilation during the DB-treatment phase were assessed as treatment failures, and thus did not fulfill by definition the clinico-pathological remission criterion. In case the primary endpoint proved to show superiority of budesonide over placebo, further key secondary endpoints could confirmatorily be tested in an a priori ordered manner until th efirst of them did not proved a superiority of budeson
    End point type
    Primary
    End point timeframe
    at week 6 (LOCF) double-blind phase
    End point values
    		 Budesonide 1mg BID Placebo BID
    Number of subjects analysed
    59
    29
    Units: patients
        yes
    34
    0
        no
    25
    29
    Attachments
    		 Primary endpoint (FAS-DB)
    Statistical analysis title
    		 Final Analysis (FAS): Budesonide 1mg vs placebo
    Comparison groups
    Budesonide 1mg BID v Placebo BID
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 1E-8 [1]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    57.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 38.22
         upper limit
    		 71.97
    Notes
    [1] - The RD was 57.63% with two-sided 95% RCI [38.22%; 71.97%]. The one-sided p-value resulting from the Fisher’s exact test was 0.00000001. The inverse normal was 5.5935 and exceeded the critical value of 2.452, thus superiority was confirmatorily shown

    Secondary: Number (%) of patients with histological remission at week 6 (LOCF) double-blind phase

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    End point title
    		 Number (%) of patients with histological remission at week 6 (LOCF) double-blind phase
    End point description
    First of the a priori ordered key secondary endpoints to be confirmatorily tested for superiority when the primary endpoint showed superiority of budesonide 1mg vs placebo.
    End point type
    Secondary
    End point timeframe
    at week 6 (LOCF) double-blind phase.
    End point values
    		 Budesonide 1mg BID Placebo BID
    Number of subjects analysed
    59
    29
    Units: patients
        yes
    55
    0
        no
    4
    29
    Statistical analysis title
    		 First a priori ordered key secondary endpoint
    Statistical analysis description
    Efficacy significance testing continued in hierarchical fashion in support of labeling claims for the key secondary endpoints until the first of these comparisons of BUET 1mg BID versus Placebo showed a one-sided p-value >0.025 (FAS-DB).
    Comparison groups
    Budesonide 1mg BID v Placebo BID
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [2]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    93.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 86.8
         upper limit
    		 99.6
    Notes
    [2] - one-sided p-value

    Secondary: Change in the peak eos/mm2 hpf from baseline to week 6 (LOCF) double-blind phase

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    End point title
    		 Change in the peak eos/mm2 hpf from baseline to week 6 (LOCF) double-blind phase
    End point description
    Second of the a priori ordered key secondary endpoints to be confirmatorily tested for superiority when the primary endpoint showed superiority of budesonide 1mg vs placebo.
    End point type
    Secondary
    End point timeframe
    at week 6 (LOCF) double-blind phase
    End point values
    		 Budesonide 1mg BID Placebo BID
    Number of subjects analysed
    59
    29
    Units: eos/mm2 hpf
        arithmetic mean (standard deviation)
    -225.5 ( 150.37 )
    -4.3 ( 135.64 )
    Statistical analysis title
    		 Second a priori ordered key secondary endpoint
    Statistical analysis description
    Efficacy significance testing continued in hierarchical fashion in support of labeling claims for the key secondary endpoints until the first of these comparisons of BUET 1mg BID versus Placebo showed a one-sided p-value >0.025 (FAS-DB).
    Comparison groups
    Budesonide 1mg BID v Placebo BID
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [3]
    Method
    		 linear least squares model
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -221.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -285
         upper limit
    		 -157.5
    Notes
    [3] - One-sided p-value for effect between treatment groups from linear least squares model with treatment group and baseline value as covariate.

    Secondary: Number (%) of patients with resolution of symptoms on each day in the week prior to week 6 (LOCF) double-blind phase

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    End point title
    		 Number (%) of patients with resolution of symptoms on each day in the week prior to week 6 (LOCF) double-blind phase
    End point description
    Third of the a priori ordered key secondary endpoints to be confirmatorily tested for superiority when the primary endpoint showed superiority of budesonide 1mg vs placebo.
    End point type
    Secondary
    End point timeframe
    at week 6 (LOCF) double-blind phase
    End point values
    		 Budesonide 1mg BID Placebo BID
    Number of subjects analysed
    59
    29
    Units: patients
        yes
    35
    4
        no
    24
    25
    Statistical analysis title
    		 Third a priori ordered key secondary endpoint
    Statistical analysis description
    Efficacy significance testing continued in hierarchical fashion in support of labeling claims for the key secondary endpoints until the first of these comparisons of BUET 1mg BID versus Placebo showed a one-sided p-value >0.025 (FAS-DB).
    Comparison groups
    Budesonide 1mg BID v Placebo BID
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [4]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    45.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 27.79
         upper limit
    		 63.27
    Notes
    [4] - one-sided p-value

    Secondary: Number (%) of patients with a total weekly EEsAI-PRO score of ≤ 20 at week 6 (LOCF) double-blind phase

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    End point title
    		 Number (%) of patients with a total weekly EEsAI-PRO score of ≤ 20 at week 6 (LOCF) double-blind phase
    End point description
    Fourth of the a priori ordered key secondary endpoints to be confirmatorily tested for superiority when the primary endpoint showed superiority of budesonide 1mg vs placebo.
    End point type
    Secondary
    End point timeframe
    at week 6 (LOCF) double-blind phase
    End point values
    		 Budesonide 1mg BID Placebo BID
    Number of subjects analysed
    59
    29
    Units: patients
        yes
    30
    2
        no
    29
    27
    Statistical analysis title
    		 Fourth a priori ordered secondary endpoint
    Statistical analysis description
    Efficacy significance testing continued in hierarchical fashion in support of labeling claims for the key secondary endpoints until the first of these comparisons of BUET 1mg BID versus Placebo showed a one-sided p-value >0.025 (FAS-DB).
    Comparison groups
    Placebo BID v Budesonide 1mg BID
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001 [5]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    43.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 28.21
         upper limit
    		 59.69
    Notes
    [5] - one-sided p-value

    Secondary: Number (%) of patients with an improvement from baseline to week 6 (LOCF) double-blind phase in the weekly Visual Dysphagia Questionnaire (VDQ) score

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    End point title
    		 Number (%) of patients with an improvement from baseline to week 6 (LOCF) double-blind phase in the weekly Visual Dysphagia Questionnaire (VDQ) score
    End point description
    Fifth of the a priori ordered key secondary endpoints to be confirmatorily tested for superiority when the primary endpoint showed superiority of budesonide 1mg vs placebo.
    End point type
    Secondary
    End point timeframe
    at week 6 (LOCF) double-blind phase
    End point values
    		 Budesonide 1mg BID Placebo BID
    Number of subjects analysed
    59
    29
    Units: patients
        yes
    30
    11
        no
    29
    18
    Statistical analysis title
    		 Fifth a priori ordered key secondary endpoint
    Statistical analysis description
    Efficacy significance testing continued in hierarchical fashion in support of labeling claims for the key secondary endpoints until the first of these comparisons of BUET 1mg BID versus Placebo showed a one-sided p-value >0.025 (FAS-DB).
    Comparison groups
    Placebo BID v Budesonide 1mg BID
    Number of subjects included in analysis
    88
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1804 [6]
    Method
    		 Fisher exact
    Parameter type
    		 Risk difference (RD)
    Point estimate
    12.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -8.87
         upper limit
    		 34.7
    Notes
    [6] - one-sided p-value. As the one-sided p-value was above 0.025, statistical superiority in this endpoint, despite numerical higher values under budesonide, could not be proven and thus confirmatory testing had to be stopped at this point.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    6 week double-blind phase
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.1
    Reporting groups
    Reporting group title
    Placebo BID
    Reporting group description
    		 Twice daily Placebo

    Reporting group title
    Budesonide 1mg BID
    Reporting group description
    		 Twice daily 1mg budesonide

    Serious adverse events
    		 Placebo BID Budesonide 1mg BID
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 29 (0.00%)
    0 / 59 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0.03%
    Non-serious adverse events
    		 Placebo BID Budesonide 1mg BID
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 29 (41.38%)
    37 / 59 (62.71%)
    Investigations
    Blood cortisol decreased
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 59 (5.08%)
         occurrences all number
    0
    3
    Injury, poisoning and procedural complications
    Arthropod bite
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Vascular disorders
    Hypertension
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    2
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 29 (3.45%)
    4 / 59 (6.78%)
         occurrences all number
    1
    4
    Blood and lymphatic system disorders
    Lymphadenopathy
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Chest pain
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Dyspepsia
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    0 / 29 (0.00%)
    3 / 59 (5.08%)
         occurrences all number
    0
    3
    Nausea
         subjects affected / exposed
    0 / 29 (0.00%)
    2 / 59 (3.39%)
         occurrences all number
    0
    2
    Oesophageal food impaction
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    2 / 29 (6.90%)
    0 / 59 (0.00%)
         occurrences all number
    2
    0
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Laryngitis
         subjects affected / exposed
    1 / 29 (3.45%)
    1 / 59 (1.69%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 29 (3.45%)
    2 / 59 (3.39%)
         occurrences all number
    1
    2
    Local fungal infection
    Additional description: In 14 patients under budesonide a local fungal infection (oral , oropharyngeal, and/or esophageal candidiasis) was suspected. Thereof, only 3 patients (5.1%) showed clinically mild symptoms with no impact on their daily life.
         subjects affected / exposed
    0 / 29 (0.00%)
    14 / 59 (23.73%)
         occurrences all number
    0
    14
    Pharyngitis
         subjects affected / exposed
    2 / 29 (6.90%)
    1 / 59 (1.69%)
         occurrences all number
    2
    1
    Sinusitis
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 59 (0.00%)
         occurrences all number
    1
    0
    Urinary tract infection
         subjects affected / exposed
    1 / 29 (3.45%)
    0 / 59 (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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