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    Clinical Trial Results:
    A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Efficacy and Safety of TEV-48574 in Adults with T2-Low/Non-T2 Severe Uncontrolled Asthma

    Summary
    EudraCT number
    2020-001927-15
    Trial protocol
    DE   BG   CZ  
    Global end of trial date
    17 Jan 2022

    Results information
    Results version number
    v1(current)
    This version publication date
    20 Jan 2023
    First version publication date
    20 Jan 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TV48574-AS-20031
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04545385
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Teva Branded Pharmaceutical Products R&D, Inc.
    Sponsor organisation address
    145 Brandywine Parkway, West Chester, United States, 19380
    Public contact
    Director, Clinical Research, Teva Branded Pharmaceutical Products R&D, Inc., MedInfo@tevaeu.com
    Scientific contact
    Director, Clinical Research, Teva Branded Pharmaceutical Products R&D, Inc., MedInfo@tevaeu.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
    17 Jan 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Jan 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Jan 2022
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of the study was to evaluate the effect of TEV-48574 compared with placebo on loss of asthma control (LoAC) in adult participants with T2-low and non-T2 severe asthma uncontrolled on inhaled corticosteroids plus long-acting beta-agonists (ICS+LABA).
    Protection of trial subjects
    This study was conducted in full accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Consolidated Guideline (E6) and any applicable national and local laws and regulations (for example, Code of Federal Regulations [CFR] Title 21, Parts 50, 54, 56, 312, and 314 and European Union (EU) Directive 2001/20/EC on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of GCP in the conduct of clinical studies on medicinal products for human use).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    07 Oct 2020
    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
    Bulgaria: 6
    Country: Number of subjects enrolled
    Czechia: 17
    Country: Number of subjects enrolled
    Germany: 4
    Country: Number of subjects enrolled
    Poland: 10
    Country: Number of subjects enrolled
    United States: 28
    Worldwide total number of subjects
    65
    EEA total number of subjects
    37
    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)
    40
    From 65 to 84 years
    25
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    A total of 65 participants were randomly assigned to treatment (33 participants in the TEV-48574 group and 32 participants in the placebo group). Of these, 64 participants received at least 1 dose of study drug.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Investigator, Carer, Assessor, Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Placebo
    Arm description
    Participants received placebo matched to TEV-48574 subcutaneously (SC) every 2 weeks for a total of 8 doses.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo matched to TEV-48574 was administered per schedule specified in the arm.

    Arm title
    TEV-48574
    Arm description
    Participants received TEV-48574 loading dose SC on the day of randomization and the subsequent corresponding TEV-48574 maintenance doses SC every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses).
    Arm type
    Experimental

    Investigational medicinal product name
    TEV-48574
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    TEV-48574 was administered per schedule specified in the arm.

    Number of subjects in period 1
    Placebo TEV-48574
    Started
    32
    33
    Received at least 1 dose of study drug
    31
    33
    Completed
    17
    20
    Not completed
    15
    13
         Consent withdrawn by subject
    2
    -
         Study termination
    10
    10
         Other than specified
    1
    -
         Sponsor decision
    2
    2
         Loss of asthma control (LoAC)
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo matched to TEV-48574 subcutaneously (SC) every 2 weeks for a total of 8 doses.

    Reporting group title
    TEV-48574
    Reporting group description
    Participants received TEV-48574 loading dose SC on the day of randomization and the subsequent corresponding TEV-48574 maintenance doses SC every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses).

    Reporting group values
    Placebo TEV-48574 Total
    Number of subjects
    32 33 65
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    56.3 ( 14.14 ) 58.8 ( 12.38 ) -
    Sex: Female, Male
    Units: participants
        Female
    19 22 41
        Male
    13 11 24
    Race/Ethnicity, Customized
    Units: Subjects
        White
    28 26 54
        Black or African American
    4 6 10
        Other
    0 1 1
    Ethnicity (NIH/OMB)
    Units: Subjects
        Hispanic or Latino
    5 6 11
        Not Hispanic or Latino
    27 27 54
        Unknown or Not Reported
    0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo matched to TEV-48574 subcutaneously (SC) every 2 weeks for a total of 8 doses.

    Reporting group title
    TEV-48574
    Reporting group description
    Participants received TEV-48574 loading dose SC on the day of randomization and the subsequent corresponding TEV-48574 maintenance doses SC every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses).

    Primary: Number of Participants who Experienced LoAC during the Treatment Period

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    End point title
    Number of Participants who Experienced LoAC during the Treatment Period
    End point description
    The LoAC was defined as any 1 of the following during the treatment period: - morning peak expiratory flow (PEF) decrease ≥30% from baseline on 2 consecutive days or morning handheld forced expiratory volume in the first second of exhalation (FEV1) decrease ≥20% from baseline on 2 consecutive days; - increase in short-acting beta-agonist (SABA)/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in inhaled corticosteroids (ICS) dose ≥4 × most recent dose; - systemic corticosteroid use; - asthma emergency room (ER) visit or hospitalization. The intent-to-treat (ITT) analysis set included all randomized participants.
    End point type
    Primary
    End point timeframe
    From randomization (Week 0) until Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    32
    33
    Units: participants
    13
    17
    Statistical analysis title
    Statistical Analysis 1
    Statistical analysis description
    Analysis was performed using logistic regression with fixed effects for treatment, baseline FEV1, weight, age group, and gender.
    Comparison groups
    Placebo v TEV-48574
    Number of subjects included in analysis
    65
    Analysis specification
    Pre-specified
    Analysis type
    other
    P-value
    = 0.7817
    Method
    Regression, Logistic
    Parameter type
    Odds ratio (OR)
    Point estimate
    1.49
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    0.545
         upper limit
    4.071

    Secondary: Time From Randomization to LoAC During the Treatment Period

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    End point title
    Time From Randomization to LoAC During the Treatment Period
    End point description
    Time (in days) from randomization to LoAC during the treatment period is the interval from randomization to the occurrence of the LoAC. The LoAC was defined as any 1 of the following during the treatment period: - morning PEF decrease ≥30% from baseline on 2 consecutive days or morning handheld FEV1 decrease ≥20% from baseline on 2 consecutive days; - increase in SABA/quick-relief medication ≥6 puffs over baseline use in 24 hours on 2 consecutive days; increase in ICS dose ≥4 × most recent dose; - systemic corticosteroid use; - asthma ER visit or hospitalization. The ITT analysis set included all randomized participants. '99999' signifies 'median and upper limit of 95% confidence interval (CI) could not be calculated due to smaller number of participants with an event'.
    End point type
    Secondary
    End point timeframe
    From randomization (Week 0) until Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    32
    33
    Units: days
        median (confidence interval 95%)
    99999 (60.0 to 99999)
    109.0 (45.0 to 99999)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16

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    End point title
    Change From Baseline in Asthma Control Questionnaire 6-Question Version (ACQ-6) Score at Week 16
    End point description
    The ACQ-6 is a 6-item validated asthma assessment tool that has been widely used. Six questions are self-assessments (completed by the participant), 5 questions assessing asthma symptoms: night-time waking, symptoms on waking, activity limitation, shortness of breath, wheezing, and 1 question for short-acting bronchodilator use. Each item on the ACQ-6 has a possible score ranges from 0 to 6, and the total score is the mean of all responses. The total score ranging from 0-6 (0=totally controlled and 6=severely uncontrolled). A higher score indicated poorer asthma control. The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    11
    16
    Units: units on a scale
        arithmetic mean (standard deviation)
    -0.560 ( 0.4546 )
    -0.833 ( 0.7250 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Forced Expiratory Volume in the First Second (FEV1) at Week 16

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    End point title
    Change From Baseline in Forced Expiratory Volume in the First Second (FEV1) at Week 16
    End point description
    FEV1 (measured by handheld spirometer) is the volume of air that can be forcibly exhaled from the lungs in the first second. The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    11
    16
    Units: %predicted FEV1
        arithmetic mean (standard deviation)
    0.121 ( 8.3126 )
    4.844 ( 12.4343 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16

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    End point title
    Change From Baseline in Daily Average Use of Short-acting Beta-agonist (SABA) Quick Relief Medication at Week 16
    End point description
    Number of inhalations/puffs of SABA/quick relief inhaler used was recorded in the e-diary daily. The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    11
    16
    Units: puffs of SABA/day
        arithmetic mean (standard deviation)
    -0.235 ( 1.2641 )
    -0.305 ( 1.6501 )
    No statistical analyses for this end point

    Secondary: Number of Participants who had a Clinical Asthma Exacerbation (CAE) During the Treatment Period

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    End point title
    Number of Participants who had a Clinical Asthma Exacerbation (CAE) During the Treatment Period
    End point description
    The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma. Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer). The ITT analysis set included all randomized participants.
    End point type
    Secondary
    End point timeframe
    From randomization (Week 0) until Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    32
    33
    Units: participants
    2
    3
    No statistical analyses for this end point

    Secondary: Time From Randomization to First CAE During the Treatment Period for Participants With CAE

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    End point title
    Time From Randomization to First CAE During the Treatment Period for Participants With CAE
    End point description
    The CAEs during the study were defined as a worsening of asthma symptoms resulting in any 1 of the following: - the use of systemic corticosteroids (oral or injectable); - an emergency department visit due to asthma treated with systemic corticosteroids; - an inpatient hospitalization due to asthma. Worsening asthma included new or increased symptoms or signs that either worried the participant or were related to an asthma-specific alert (if available through the e-diary/handheld spirometer). The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    From randomization (Week 0) until Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    2
    3
    Units: days
        median (full range (min-max))
    46.5 (38 to 55)
    37.0 (30 to 54)
    No statistical analyses for this end point

    Secondary: Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16

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    End point title
    Change From Baseline in Number of Nighttime Awakenings Due to Asthma at Week 16
    End point description
    Participants recorded the number of nighttime awakenings due to asthma in the e-diary daily, in the morning. The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    11
    16
    Units: nighttime awakenings
        arithmetic mean (standard deviation)
    -1.224 ( 2.0182 )
    -0.208 ( 2.7274 )
    No statistical analyses for this end point

    Secondary: Percent Change in ICS Dose During the Treatment Period

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    End point title
    Percent Change in ICS Dose During the Treatment Period
    End point description
    The ICS use were recorded as one of asthma medications in the prior and concomitant medication data on the case record form. Due to change in planned analysis, this outcome measure was not evaluated.
    End point type
    Secondary
    End point timeframe
    From randomization (Week 0) until Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    0 [1]
    0 [2]
    Units: percent change
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [1] - Due to change in planned analysis, this outcome measure was not evaluated.
    [2] - Due to change in planned analysis, this outcome measure was not evaluated.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Forced Vital Capacity (FVC) at Week 16

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    End point title
    Change From Baseline in Forced Vital Capacity (FVC) at Week 16
    End point description
    FVC (measured by handheld spirometer) is the volume of air that can be forcibly and completely blown out after full inspiration, measured in liters. The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    11
    16
    Units: liters
        arithmetic mean (standard deviation)
    0.014 ( 0.3052 )
    0.155 ( 0.3964 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16

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    End point title
    Change From Baseline in Forced Expiratory Flow at 25-75% of Pulmonary Volume (FEF25%-75%) at Week 16
    End point description
    The FEF25%-75% (measured by handheld spirometer) is the forced expiratory flow from 25% to 75% of FVC. The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    11
    16
    Units: liters/second
        arithmetic mean (standard deviation)
    -0.026 ( 0.2451 )
    0.166 ( 0.4342 )
    No statistical analyses for this end point

    Secondary: Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16

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    End point title
    Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) at Week 16
    End point description
    FeNO was performed prior to the on-site spirometry. The ITT analysis set included all randomized participants. Here, 'Overall number of participants analyzed' = participants evaluable for this endpoint.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 16
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    11
    16
    Units: parts per billion (ppb)
        arithmetic mean (standard deviation)
    5.364 ( 6.9609 )
    10.375 ( 12.5850 )
    No statistical analyses for this end point

    Secondary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

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    End point title
    Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
    End point description
    An AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. AEs were considered treatment emergent (TEAEs) if onset occurred on or after the first dose date. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'. Safety analysis set included all randomized participants who received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    From randomization (Week 0) until Week 24
    End point values
    Placebo TEV-48574
    Number of subjects analysed
    31
    33
    Units: participants
    14
    18
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From randomization (Week 0) until Week 24
    Adverse event reporting additional description
    Safety analysis set included all randomized participants who received at least 1 dose of study drug.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    24.0
    Reporting groups
    Reporting group title
    TEV-48574
    Reporting group description
    Participants received TEV-48574 loading dose SC on the day of randomization and the subsequent corresponding TEV-48574 maintenance doses SC every 2 weeks for a total of 8 doses (1 loading dose and 7 maintenance doses).

    Reporting group title
    Placebo
    Reporting group description
    Participants received placebo matched to TEV-48574 SC every 2 weeks for a total of 8 doses.

    Serious adverse events
    TEV-48574 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 33 (3.03%)
    1 / 31 (3.23%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertensive crisis
         subjects affected / exposed
    1 / 33 (3.03%)
    0 / 31 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Vaginal prolapse
         subjects affected / exposed
    0 / 33 (0.00%)
    1 / 31 (3.23%)
         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: 5%
    Non-serious adverse events
    TEV-48574 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 33 (18.18%)
    4 / 31 (12.90%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 33 (9.09%)
    2 / 31 (6.45%)
         occurrences all number
    3
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    3 / 33 (9.09%)
    3 / 31 (9.68%)
         occurrences all number
    3
    3

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 Nov 2020
    The following major procedural changes (not all-inclusive) were made to the protocol: - addition of a Joint Data Monitoring Committee to monitor safety of the participants; addition of a futility analysis at the interim analysis; - clarification that the window for the screening and run-in period could also be 4 weeks; - clarification regarding timing of FeNO assessment; additional procedures to confirm TB diagnosis; - clarification that handheld spirometers should not be used for FEV1 testing at screening; - addition of reslizumab to the list of examples of systemic immunosuppressive or immunomodulatory agents.
    28 Apr 2021
    The following major procedural changes (not all-inclusive) were made to the protocol: - changes to the inclusion and exclusion criteria to increase enrollment to the study related to participants with prior COVID-19 infection, COVID-19 vaccination, and positive urine test for tetrahydrocannabinol (THC); - addition of malignancies to immunosuppression risk and immunosuppression risk to align with the informed consent form (ICF); - removal of sputum collection; - addition of defining criteria of a participant having T2-low/non-T2 asthma (possessing eosinophil count of <250 cells/microliter [μL] of blood); - addition of text ensuring participants who tested positive for COVID-19 infection were discontinued from investigational medicinal product (IMP); - additional details for primary and secondary efficacy analysis and interim futility analysis; - clarification of specific examples of the types of respiratory conditions that would meet exclusion criterion “a” to provide further context for the investigators.

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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