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    Clinical Trial Results:
    A Phase 3, Rollover Study to Evaluate the Safety of Long-term Treatment With Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation

    Summary
    EudraCT number
    		 2019-003112-31
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    17 Jul 2019

    Results information
    Results version number
    		 v2(current)
    This version publication date
    25 Oct 2020
    First version publication date
    01 Feb 2020
    Other versions
    		 v1
    Version creation reason

    Trial information

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    Trial identification
    Sponsor protocol code
    VX16-809-116
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03125395
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Vertex Pharmaceuticals Incorporated
    Sponsor organisation address
    50 Northern Avenue, Boston, Massachusetts, United States,
    Public contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 617 341 6777, medicalinfo@vrtx.com
    Scientific contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 617 341 6777, medicalinfo@vrtx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001582-PIP01-13
    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?
    Yes
    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
    17 Jul 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jul 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the long-term safety of lumacaftor (LUM)/ivacaftor (IVA) combination therapy in subjects aged 2 years and older with cystic fibrosis (CF), homozygous for F508del.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Council on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 May 2017
    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
    Canada: 7
    Country: Number of subjects enrolled
    United States: 50
    Worldwide total number of subjects
    57
    EEA total number of subjects
    0
    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)
    57
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was planned to have 2 cohorts: Treatment Cohort and Observational Cohort. Only the Treatment Cohort is presented in results as there were no subjects enrolled in the Observational Cohort.

    Pre-assignment
    Screening details
    		 This study was conducted in subjects with CF aged 2 years and older who participated in parent study VX15-809-115 Part B (NCT02797132).

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

    Arms
    Arm title
    		 LUM/IVA
    Arm description
    		 LUM/IVA granules or tablets were administered orally every 12 hours (subjects aged 2 through 5 years received LUM 100 milligram (mg)/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Subjects ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.
    Arm type
    		 Experimental

    Investigational medicinal product name
    LUM/IVA
    Investigational medicinal product code
    VX-809/VX-770
    Other name
    Lumacaftor/Ivacaftor
    Pharmaceutical forms
    Granules, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects who received LUM/IVA every 12 hours.

    Number of subjects in period 1
    		LUM/IVA
    Started
    57
    Completed
    47
    Not completed
    10
         Physician decision
    2
         Commercial Drug is Available for Subject
    5
         Adverse Event
    2
         Withdrawal of Consent (Not Due to AE)
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LUM/IVA
    Reporting group description
    		 LUM/IVA granules or tablets were administered orally every 12 hours (subjects aged 2 through 5 years received LUM 100 milligram (mg)/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Subjects ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.

    Reporting group values
    		 LUM/IVA Total
    Number of subjects
    		 57 57
    Age categorical
    Units: Subjects
    Age continuous
    Units: months
        arithmetic mean (standard deviation)
    		 43.2 ± 12.17 -
    Gender categorical
    Units: Subjects
        Female
    		 28 28
        Male
    		 29 29
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 3 3
        Not Hispanic or Latino
    		 54 54
        Unknown or Not Reported
    		 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 0 0
        Asian
    		 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0
        Black or African American
    		 0 0
        White
    		 56 56
        More than one race
    		 0 0
        Unknown or Not Reported
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    LUM/IVA
    Reporting group description
    		 LUM/IVA granules or tablets were administered orally every 12 hours (subjects aged 2 through 5 years received LUM 100 milligram (mg)/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Subjects ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.

    Primary: Safety as Assessed by Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

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    End point title
    		 Safety as Assessed by Number of Subjects With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [1]
    End point description
    Study 116 safety set included all subjects dosed in study 115B who were exposed to any amount of study drug in current study 116 treatment cohort.
    End point type
    Primary
    End point timeframe
    Day 1 up to Week 98
    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: Only descriptive statistics were planned. No statistical comparisons were planned for primary safety endpoint.
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57
    Units: subjects
        AEs
    56
        SAEs
    15
    No statistical analyses for this end point

    Secondary: Absolute Change in Sweat Chloride

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    End point title
    		 Absolute Change in Sweat Chloride
    End point description
    Sweat samples were collected using an approved collection device. Study 116 Full Analysis Set (FAS) included all subjects who were enrolled and exposed to any amount of study drug in current study 116.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline at Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57
    Units: millimole per liter (mmol/L)
        arithmetic mean (standard deviation)
    -29.6 ± 12.7
    No statistical analyses for this end point

    Secondary: Absolute Change in Body Mass Index (BMI)

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    End point title
    		 Absolute Change in Body Mass Index (BMI)
    End point description
    BMI was defined as weight in kilogram (kg) divided by height in square meter (m^2). Study 116 FAS.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline at Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57
    Units: kg/m^2
        arithmetic mean (standard deviation)
    0.30 ± 1.21
    No statistical analyses for this end point

    Secondary: Absolute Change in BMI-for-age Z-score

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    End point title
    		 Absolute Change in BMI-for-age Z-score
    End point description
    BMI was defined as weight in kilograms divided by height in m^2. z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Study 116 FAS.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline at Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57
    Units: z-score
        arithmetic mean (standard deviation)
    0.27 ± 0.73
    No statistical analyses for this end point

    Secondary: Absolute Change in Weight

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    End point title
    		 Absolute Change in Weight
    End point description
    Study 116 FAS.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline at Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57
    Units: kg
        arithmetic mean (standard deviation)
    6.0 ± 2.0
    No statistical analyses for this end point

    Secondary: Absolute Change in Weight-for-age Z-score

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    End point title
    		 Absolute Change in Weight-for-age Z-score
    End point description
    Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Study 116 FAS.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline at Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57
    Units: z-score
        arithmetic mean (standard deviation)
    0.23 ± 0.56
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Stature (Height)

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    End point title
    		 Absolute Change From Baseline in Stature (Height)
    End point description
    Study 116 FAS.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline at Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57
    Units: centimeter
        arithmetic mean (standard deviation)
    16.1 ± 2.3
    No statistical analyses for this end point

    Secondary: Absolute Change in Stature-for-age Z-score

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    End point title
    		 Absolute Change in Stature-for-age Z-score
    End point description
    Z-score is a statistical measure to describe whether a mean was above or below the standard. A z-score of 0 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Study 116 FAS.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline at Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57
    Units: z-score
        arithmetic mean (standard deviation)
    0.07 ± 0.39
    No statistical analyses for this end point

    Secondary: Time-to-first Pulmonary Exacerbation

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    End point title
    		 Time-to-first Pulmonary Exacerbation
    End point description
    Pulmonary exacerbation was defined as new or changed treatment with oral, inhaled, or intravenous antibiotics and fulfillment of pre-specified protocol-defined criteria. Study 115B FAS (N=60) included all subjects who were enrolled and exposed to any amount of study drug in parent study 115B. Here, 99999 represents "Not Available" as Upper limit of inter-quartile range could not be estimated because less than 75% of subjects had events.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline through Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57 [2]
    Units: days
        median (inter-quartile range (Q1-Q3))
    600.0 (98.0 to 99999)
    Notes
    [2] - Study 115B FAS included 60 subjects.
    No statistical analyses for this end point

    Secondary: Number of Pulmonary Exacerbations

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    End point title
    		 Number of Pulmonary Exacerbations
    End point description
    Pulmonary exacerbation was defined as new or changed treatment with oral, inhaled, or intravenous antibiotics and fulfillment of pre-specified protocol-defined criteria. Study 115B FAS.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline through Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57 [3]
    Units: pulmonary exacerbation events
    82
    Notes
    [3] - Study 115B FAS included 60 subjects.
    No statistical analyses for this end point

    Secondary: Number of Cystic Fibrosis Related Hospitalizations

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    End point title
    		 Number of Cystic Fibrosis Related Hospitalizations
    End point description
    Study 115B FAS.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline through Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57 [4]
    Units: hospitalizations
    28
    Notes
    [4] - Study 115B FAS included 60 subjects.
    No statistical analyses for this end point

    Secondary: Absolute Change in Fecal Elastase-1 (FE-1) Levels

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    End point title
    		 Absolute Change in Fecal Elastase-1 (FE-1) Levels
    End point description
    Study 116 FAS.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline at Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57
    Units: microgram per gram (mcg/g)
        arithmetic mean (standard deviation)
    132.6 ± 174.2
    No statistical analyses for this end point

    Secondary: Absolute Change in Immunoreactive Trypsinogen (IRT) Serum Levels

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    End point title
    		 Absolute Change in Immunoreactive Trypsinogen (IRT) Serum Levels
    End point description
    Study 116 FAS.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline at Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    57
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    -108.5 ± 306.6
    No statistical analyses for this end point

    Secondary: Number of Subjects With Microbiology Culture Status (Positive or Negative)

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    End point title
    		 Number of Subjects With Microbiology Culture Status (Positive or Negative)
    End point description
    Following microbial tests were performed: Burkholderia, Methicillin Resistant Staphylococcus Aureus (MRSA), Methicillin Susceptible Staphylococcus Aureus (MSSA), Pseudomonas Aeruginosa Mucoid (P. Aeruginosa Mucoid), P. Aeruginosa Non-Mucoid, P. Aeruginosa Small Colony Variant and Stenotrophomonas Maltophilia. Study 116 FAS. Here "Subject analysed" signifies those subjects who were evaluated for this outcome at Week 96.
    End point type
    Secondary
    End point timeframe
    Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    46
    Units: Subjects
        Burkholderia (Positive)
    0
        Burkholderia (Negative)
    46
        MRSA (Positive)
    4
        MRSA (Negative)
    42
        MSSA (Positive)
    15
        MSSA (Negative)
    31
        P. Aeruginosa Mucoid (Positive)
    0
        P. Aeruginosa Mucoid (Negative)
    46
        P. Aeruginosa Non-Mucoid (Positive)
    1
        P. Aeruginosa Non-Mucoid (Negative)
    45
        P. Aeruginosa Small Colony Variant (Positive)
    0
        P. Aeruginosa Small Colony Variant (Negative)
    46
        Stenotrophomonas Maltophilia (Positive)
    2
        Stenotrophomonas Maltophilia (Negative)
    44
    No statistical analyses for this end point

    Secondary: Absolute Change in Lung Clearance Index (LCI) 2.5

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    End point title
    		 Absolute Change in Lung Clearance Index (LCI) 2.5
    End point description
    LCI 2.5 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/40th of its starting value. Study 116 LCI substudy set included all subjects who signed the informed consent/assent to the optional LCI substudy and were enrolled and exposed to any amount of study drug in current study 116.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline at Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    31
    Units: lung clearance index
        arithmetic mean (standard deviation)
    -0.20 ± 1.55
    No statistical analyses for this end point

    Secondary: Absolute Change in Lung Clearance Index (LCI) 5.0

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    End point title
    		 Absolute Change in Lung Clearance Index (LCI) 5.0
    End point description
    LCI 5.0 represents the number of lung turnovers required to reduce the end tidal inert gas concentration to 1/20th of its starting value. Study 116 LCI substudy set.
    End point type
    Secondary
    End point timeframe
    From Parent Study 115B Baseline at Week 96
    End point values
    		 LUM/IVA
    Number of subjects analysed
    31
    Units: lung clearance index
        arithmetic mean (standard deviation)
    0.11 ± 0.65
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Day 1 Up to Week 98
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    LUM/IVA
    Reporting group description
    		 LUM/IVA granules or tablets were administered orally every 12 hours (subjects aged 2 through 5 years received LUM 100 mg/IVA 125 mg granules or LUM 150 mg/IVA 188 mg granules based on body weight. Subjects ≥6 years of age were to receive LUM 200 mg/IVA 250 mg tablets). Doses were adjusted upward for changes in weight and age.

    Serious adverse events
    		 LUM/IVA
    Total subjects affected by serious adverse events
         subjects affected / exposed
    15 / 57 (26.32%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Aspartate aminotransferase increased
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Constipation
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Haematemesis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pancreatitis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Sleep apnoea syndrome
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Appendicitis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Chronic sinusitis
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastritis viral
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis viral
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis adenovirus
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    6 / 57 (10.53%)
         occurrences causally related to treatment / all
    3 / 9
         deaths causally related to treatment / all
    0 / 0
    Pneumonia
         subjects affected / exposed
    2 / 57 (3.51%)
         occurrences causally related to treatment / all
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    Respiratory tract infection viral
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Weight gain poor
         subjects affected / exposed
    1 / 57 (1.75%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 LUM/IVA
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    55 / 57 (96.49%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    10 / 57 (17.54%)
         occurrences all number
    19
    Aspartate aminotransferase increased
         subjects affected / exposed
    5 / 57 (8.77%)
         occurrences all number
    8
    Forced expiratory volume decreased
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    4
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    4
    Pseudomonas test positive
         subjects affected / exposed
    9 / 57 (15.79%)
         occurrences all number
    9
    Staphylococcus test positive
         subjects affected / exposed
    12 / 57 (21.05%)
         occurrences all number
    14
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 57 (8.77%)
         occurrences all number
    6
    Pyrexia
         subjects affected / exposed
    23 / 57 (40.35%)
         occurrences all number
    42
    Vessel puncture site pain
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    14
    Ear and labyrinth disorders
    Ear pain
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    7 / 57 (12.28%)
         occurrences all number
    8
    Constipation
         subjects affected / exposed
    7 / 57 (12.28%)
         occurrences all number
    9
    Abdominal pain upper
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    5
    Diarrhoea
         subjects affected / exposed
    6 / 57 (10.53%)
         occurrences all number
    6
    Vomiting
         subjects affected / exposed
    17 / 57 (29.82%)
         occurrences all number
    22
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    47 / 57 (82.46%)
         occurrences all number
    159
    Dyspnoea
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Lower respiratory tract congestion
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    4
    Nasal discharge discolouration
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Nasal congestion
         subjects affected / exposed
    25 / 57 (43.86%)
         occurrences all number
    37
    Oropharyngeal pain
         subjects affected / exposed
    10 / 57 (17.54%)
         occurrences all number
    12
    Productive cough
         subjects affected / exposed
    5 / 57 (8.77%)
         occurrences all number
    8
    Rhinorrhoea
         subjects affected / exposed
    18 / 57 (31.58%)
         occurrences all number
    26
    Sinus congestion
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Sputum increased
         subjects affected / exposed
    5 / 57 (8.77%)
         occurrences all number
    8
    Upper respiratory tract congestion
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    5
    Wheezing
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    4
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Infections and infestations
    Conjunctivitis
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    5
    Ear infection
         subjects affected / exposed
    12 / 57 (21.05%)
         occurrences all number
    21
    Hand-foot-and-mouth disease
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    3
    Infective pulmonary exacerbation of cystic fibrosis
         subjects affected / exposed
    10 / 57 (17.54%)
         occurrences all number
    17
    Influenza
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    4
    Nasopharyngitis
         subjects affected / exposed
    8 / 57 (14.04%)
         occurrences all number
    20
    Pharyngitis streptococcal
         subjects affected / exposed
    6 / 57 (10.53%)
         occurrences all number
    11
    Otitis media
         subjects affected / exposed
    7 / 57 (12.28%)
         occurrences all number
    9
    Pneumonia
         subjects affected / exposed
    3 / 57 (5.26%)
         occurrences all number
    4
    Sinusitis
         subjects affected / exposed
    12 / 57 (21.05%)
         occurrences all number
    17
    Upper respiratory tract infection
         subjects affected / exposed
    13 / 57 (22.81%)
         occurrences all number
    16
    Viral upper respiratory tract infection
         subjects affected / exposed
    4 / 57 (7.02%)
         occurrences all number
    4
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    6 / 57 (10.53%)
         occurrences all number
    6

    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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