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    Clinical Trial Results:
    EFFECT OF ELECTRONIC MONITORING AND FEEDBACK ON ADHERENCE TO EASYHALER CONTROLLER MEDICATION IN PATIENTS WITH ASTHMA

    Summary
    EudraCT number
    2019-003082-17
    Trial protocol
    DE  
    Global end of trial date
    24 Apr 2024

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Apr 2025
    First version publication date
    26 Apr 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    3103017
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT04869384
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Orion Corporation
    Sponsor organisation address
    Orionintie 1, Espoo, Finland, 02200
    Public contact
    Clinical Trial Information Desk, Orion Corporation Orion Pharma, +358 104261, clinicaltrials@orionpharma.com
    Scientific contact
    Clinical Trial Information Desk, Orion Corporation Orion Pharma, +358 104261, clinicaltrials@orionpharma.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
    24 Apr 2024
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    24 Apr 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to compare mean weekly adherence to controller medication between the intervention group using Connected Easyhaler and the control group (active usual care) during the last 6 weeks of the study.
    Protection of trial subjects
    Use of Connected Easyhaler was not considered to add any safety concern compared to normal use of inhalers. The trial enrolled adult asthmatic patients with suboptimal asthma control who were currently receiving inhaled budesonide, budesonide/formoterol combination or salmeterol/fluticasone propionate combination as their controller medication. Adverse events were collected from the time that a trial participant signed the IC form until the end-of-trial visit at 6 months. Salbutamol was used as rescue medication as needed.
    Background therapy
    In addition to study medication, the use of possible other asthma medications was permitted and the dose continued as before the trial.
    Evidence for comparator
    -
    Actual start date of recruitment
    23 Jun 2021
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Germany: 158
    Worldwide total number of subjects
    158
    EEA total number of subjects
    158
    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)
    157
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A total of 171 participants were screened for the trial in Germany, with 78 participants being randomised into the Intervention group and 80 participants randomised into the Usual Care group.

    Pre-assignment
    Screening details
    Male and female participants, aged 18-65 years with asthma, ACT score 19 or less, were recruited. Participant must have been used their control medication (budesonide, budesonide/formoterol combination or salmeterol/fluticasone) at constant dose for at least 3 months before screening, and to be able to switch to Easyhaler.

    Pre-assignment period milestones
    Number of subjects started
    158
    Number of subjects completed
    158

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    This was an open-label trial.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Intervention
    Arm description
    Participants in the Intervention group had sensors attached to their controller and reliever medication inhalers and the mobile application installed to their mobile phones. The sensors monitored use of medications by capturing date, time and number of uses. The participants in this group got reminders (sound and/or light) on the controller medication use via sensor and mobile application. In addition, there were push notifications via mobile application. At study visits, the adherence data accumulated since the previous visit was reviewed by the investigator/nurse using the Provider Portal and discussed with the subject.
    Arm type
    Experimental

    Investigational medicinal product name
    Budesonide Easyhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Individual dosing instructed by the treating physician.

    Investigational medicinal product name
    Budesonide/Formoterol Easyhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Individual dosing instructed by the treating physician.

    Investigational medicinal product name
    Salmeterol/Fluticasone propionate Easyhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Individual dosing instructed by the treating physician.

    Investigational medicinal product name
    Salbutamol Easyhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Reliever medication, used as needed (in accordance with SmPC).

    Arm title
    Usual Care
    Arm description
    Participants in the Usual Care group had sensors attached to their controller and reliever medication inhalers and the mobile application installed to their mobile phones as in the Intervention group. They were told that the sensors monitor how much the inhalers are used; however, the reminders/alarms of the sensors were disabled, and the participants or health care professionals could not review information collected from the sensor via the mobile application.
    Arm type
    Active comparator

    Investigational medicinal product name
    Budesonide Easyhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Individual dosing instructed by the treating physician.

    Investigational medicinal product name
    Salbutamol Easyhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Reliever medication, used as needed (in accordance with SmPC).

    Investigational medicinal product name
    Salmeterol/Fluticasone propionate Easyhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Individual dosing instructed by the treating physician.

    Investigational medicinal product name
    Budesonide/Formoterol Easyhaler
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation powder
    Routes of administration
    Inhalation use
    Dosage and administration details
    Individual dosing instructed by the treating physician.

    Number of subjects in period 1
    Intervention Usual Care
    Started
    78
    80
    Completed
    77
    77
    Not completed
    1
    3
         Consent withdrawn by subject
    1
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Intervention
    Reporting group description
    Participants in the Intervention group had sensors attached to their controller and reliever medication inhalers and the mobile application installed to their mobile phones. The sensors monitored use of medications by capturing date, time and number of uses. The participants in this group got reminders (sound and/or light) on the controller medication use via sensor and mobile application. In addition, there were push notifications via mobile application. At study visits, the adherence data accumulated since the previous visit was reviewed by the investigator/nurse using the Provider Portal and discussed with the subject.

    Reporting group title
    Usual Care
    Reporting group description
    Participants in the Usual Care group had sensors attached to their controller and reliever medication inhalers and the mobile application installed to their mobile phones as in the Intervention group. They were told that the sensors monitor how much the inhalers are used; however, the reminders/alarms of the sensors were disabled, and the participants or health care professionals could not review information collected from the sensor via the mobile application.

    Reporting group values
    Intervention Usual Care Total
    Number of subjects
    78 80 158
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    78 79 157
        From 65-84 years
    0 1 1
    Gender categorical
    Units: Subjects
        Female
    42 51 93
        Male
    36 29 65

    End points

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    End points reporting groups
    Reporting group title
    Intervention
    Reporting group description
    Participants in the Intervention group had sensors attached to their controller and reliever medication inhalers and the mobile application installed to their mobile phones. The sensors monitored use of medications by capturing date, time and number of uses. The participants in this group got reminders (sound and/or light) on the controller medication use via sensor and mobile application. In addition, there were push notifications via mobile application. At study visits, the adherence data accumulated since the previous visit was reviewed by the investigator/nurse using the Provider Portal and discussed with the subject.

    Reporting group title
    Usual Care
    Reporting group description
    Participants in the Usual Care group had sensors attached to their controller and reliever medication inhalers and the mobile application installed to their mobile phones as in the Intervention group. They were told that the sensors monitor how much the inhalers are used; however, the reminders/alarms of the sensors were disabled, and the participants or health care professionals could not review information collected from the sensor via the mobile application.

    Primary: Mean weekly adherence to controller medication

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    End point title
    Mean weekly adherence to controller medication
    End point description
    The primary efficacy variable was mean weekly adherence to controller medication (the percentage of doses taken of the doses prescribed) during the last 6 weeks of treatment. The use of controller medication was recorded by the sensor attached to the inhaler in both groups. The adherence was compared between participants who did and did not receive reminders and feedback on their medication use via Connected Easyhaler.
    End point type
    Primary
    End point timeframe
    The last 6 weeks of treatment of the 6 month treatment period.
    End point values
    Intervention Usual Care
    Number of subjects analysed
    78
    80
    Units: percent
        least squares mean (confidence interval 95%)
    79.07 (72.1 to 86.05)
    57.36 (50.24 to 65.47)
    Statistical analysis title
    Comparison of change in adherence from baseline
    Statistical analysis description
    Comparison of change in adherence from baseline between the groups.
    Comparison groups
    Intervention v Usual Care
    Number of subjects included in analysis
    158
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    P-value
    < 0.05
    Method
    ANCOVA
    Parameter type
    Mean difference (net)
    Point estimate
    21.72
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    11.75
         upper limit
    31.68

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were collected from the time that a trial participant signed the IC form until the end-of-trial visit at 6 months.
    Adverse event reporting additional description
    The adverse events reported during the run-in period were included.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    26.1
    Reporting groups
    Reporting group title
    Intervention
    Reporting group description
    Participants in the Intervention group had sensors attached to their controller and reliever medication inhalers and the mobile application installed to their mobile phones. The sensors monitored use of medications by capturing date, time and number of uses. The participants in this group got reminders (sound and/or light) on the controller medication use via sensor and mobile application. In addition, there were push notifications via mobile application. At study visits, the adherence data accumulated since the previous visit was reviewed by the investigator/nurse using the Provider Portal and discussed with the subject.

    Reporting group title
    Usual Care
    Reporting group description
    Participants in the Usual Care group had sensors attached to their controller and reliever medication inhalers and the mobile application installed to their mobile phones as in the Intervention group. They were told that the sensors monitor how much the inhalers are used; however, the reminders/alarms of the sensors were disabled, and the participants or health care professionals could not review information collected from the sensor via the mobile application.

    Serious adverse events
    Intervention Usual Care
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 78 (2.56%)
    1 / 80 (1.25%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    ANKLE FRACTURE
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    WRIST FRACTURE
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    MATERNAL EXPOSURE DURING PREGNANCY
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    INCISIONAL HERNIA
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         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
    Intervention Usual Care
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    24 / 78 (30.77%)
    29 / 80 (36.25%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    MELANOCYTIC NAEVUS
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    Injury, poisoning and procedural complications
    ACCIDENT
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    BONE CONTUSION
         subjects affected / exposed
    0 / 78 (0.00%)
    2 / 80 (2.50%)
         occurrences all number
    0
    2
    CONTUSION
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    CRANIOCEREBRAL INJURY
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    FOOT FRACTURE
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    HEAD INJURY
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    IMMUNISATION REACTION
         subjects affected / exposed
    4 / 78 (5.13%)
    2 / 80 (2.50%)
         occurrences all number
    4
    2
    LIGAMENT RUPTURE
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    LIMB INJURY
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    Surgical and medical procedures
    INTERNAL FIXATION OF FRACTURE
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    CERVICOBRACHIAL SYNDROME
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    HEADACHE
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    Immune system disorders
    DRUG HYPERSENSITIVITY
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    DIARRHOEA
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    GASTROOESOPHAGEAL REFLUX DISEASE
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    HAEMORRHOIDAL HAEMORRHAGE
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    Respiratory, thoracic and mediastinal disorders
    ASTHMA
         subjects affected / exposed
    5 / 78 (6.41%)
    5 / 80 (6.25%)
         occurrences all number
    7
    6
    DYSPHONIA
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    SKIN IRRITATION
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    Psychiatric disorders
    DEPRESSION
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    BACK PAIN
         subjects affected / exposed
    0 / 78 (0.00%)
    2 / 80 (2.50%)
         occurrences all number
    0
    2
    PAIN IN EXTREMITY
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    TENDONITIS
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    BRONCHITIS
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    BRONCHITIS BACTERIAL
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    CANDIDA INFECTION
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    CORONAVIRUS INFECTION
         subjects affected / exposed
    1 / 78 (1.28%)
    1 / 80 (1.25%)
         occurrences all number
    1
    1
    COVID-19
         subjects affected / exposed
    10 / 78 (12.82%)
    10 / 80 (12.50%)
         occurrences all number
    10
    10
    GASTROINTESTINAL INFECTION
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    NASOPHARYNGITIS
         subjects affected / exposed
    7 / 78 (8.97%)
    6 / 80 (7.50%)
         occurrences all number
    8
    6
    MASTITIS
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    JOINT ABSCESS
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    LARYNGITIS
         subjects affected / exposed
    2 / 78 (2.56%)
    1 / 80 (1.25%)
         occurrences all number
    2
    1
    SKIN INFECTION
         subjects affected / exposed
    1 / 78 (1.28%)
    0 / 80 (0.00%)
         occurrences all number
    1
    0
    ROOT CANAL INFECTION
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    1
    RESPIRATORY TRACT INFECTION
         subjects affected / exposed
    0 / 78 (0.00%)
    1 / 80 (1.25%)
         occurrences all number
    0
    2

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Feb 2020
    Amendment 1. Changes requested by German regulatory authority BfArM: -Further rationale for patient selection was added to the protocol to justify the inclusion of participants with ACT score ≤19 (5-19). -The use of other asthma mediation was clarified. -Time period for the use of the controller medication at constant dose from at least 1 month was extended to 3 months prior to the screening visit. -A summary of pertinent safety information was included. -The 6-week phone call was removed in order not to create bias. -Pregnancy testing was included to screening for WOCBP -The requirement for WOCBP to use adequate contraception was included. -Paradoxical bronchospasm was added as an example for discontinuing the trial treatment for a participant. -Criteria for discontinuation of the trial were added. -The use of Salbutamol Easyhaler as a reliever medication was clarified. -A new section containing potent inhibitors of CYP3A was added. -Trial procedures at screening were clarified. -It was clarified that participants can call Propeller customer support if they have any questions or concerns related to the sensor or the application. -More detailed information on spirometric measurements was given. -Clarification for pregnancy during the trial was added. -Text concerning discontinuation of the trial was reorganised and added under section 4.7. -Detailed information on contraception methods considered acceptable in this trial based on the Clinical Trial Facilitation Group recommendation was added.
    28 May 2020
    The amended protocol was created to implement changes requested by German central ethics committee. -Primary objective was clarified. - Secondary objectives were clarified. -Timeline the participant had used an investigational drug was determined more precisely. -Exclusion of individuals who are subordinate to the Sponsor or institutionalised as a result of an administrative or court order were added. -Race as a data to be collected was removed. -Protocol deviation as a reason for participant’s discontinuation was removed -A reason for discontinuing the trial was added. -Ratio for distribution into treatment groups were added. -Easyhaler inhaler technique checking and training missing from randomisation visit was added. -Data related to variable Healthcare utilisation related to asthma to be collected from CRF was removed. -Data related to variable Number of missing working or trial days due to asthma symptoms to be collected from CRF was removed. -Clarification that non-compliance is not considered as a protocol deviation for per-protocol population was added. -Statistical analysis for the primary endpoint was described in more detail. -Clarification related to secondary variable adherence to controller medication was added.
    24 Nov 2020
    An amendment to a protocol was created and implemented due to Covid-19 pandemic. -Obtaining baseline data about adherence was added. -Benefit-risk assessment was updated to include the possible risks associated with Covid-19. -The smart phone versions supported were updated. -Time from previous upper or lower respiratory infection was prolonged from 7 to 14 days due to possible covid-19 infection. -The need to return Easyhaler inhalers at every visit was removed because post-randomisation visits (Visit 3 and Visit 4) could have been carried out remotely (a telephone visit, home visit or video call) due to restrictions related to covid-19. -Asthma symptom control was removed as it was accidentally included into the original protocol. Assessment of asthma control according to GINA was considered at the time of protocol development but left out as ACT was included. This correction was missed in the previous amendments. -The precautions due to Covid-19 pandemic and possible protocol assessments during remote visits were added. -Clarifications into data collection was added.
    02 Mar 2021
    An amendment was created to implement the changes requested by German central ethics committee. -Additional covid-19 precautions including covid-19 testing were added. -Trial dates (start and complete) were updated due to Covid-19.

    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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