Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7293   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase II/III seamless, randomised, double-blind, placebo-controlled, parallel-group, group-sequential study to evaluate efficacy, safety and tolerability of BI 767551 for the treatment of symptomatic, non-hospitalized adults with mild to moderate COVID-19

    Summary
    EudraCT number
    		 2020-005588-29
    Trial protocol
    		 BE   DK   NL   PT   DE   ES  
    Global end of trial date
    04 Oct 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    04 Sep 2022
    First version publication date
    14 Jul 2022
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1487-0001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04822701
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Boehringer Ingelheim
    Sponsor organisation address
    Binger Strasse 173, Ingelheim am Rhein, Germany, 55216
    Public contact
    Boehringer Ingelheim Call Center, Boehringer Ingelheim, +1 18002430127, clintriage.rdg@boehringer-ingelheim.com
    Scientific contact
    Boehringer Ingelheim Call Center, Boehringer Ingelheim, +1 18002430127, clintriage.rdg@boehringer-ingelheim.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
    16 Nov 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Jul 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    04 Oct 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the concept of pharmacological activity of BI 767551 in non-hospitalised patients with mild to moderate COVID-19 symptoms and to identify a potentially efficacious and safe dose regimen from the Phase II part to take into the Phase III part. To evaluate the efficacy, safety, and tolerability of BI 767551 for the treatment of symptomatic, non-hospitalised adults with mild to moderate COVID-19.
    Protection of trial subjects
    Only subjects that met all the study inclusion and none of the exclusion criteria were to be entered in the study. All subjects were free to withdraw from the clinical trial at any time for any reason given. Close monitoring of all subjects was adhered to throughout the trial conduct. Rescue medication was allowed for all patients as required.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    17 Jun 2021
    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
    Spain: 1
    Country: Number of subjects enrolled
    United States: 6
    Worldwide total number of subjects
    7
    EEA total number of subjects
    1
    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)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This study was planned to evaluate the concept of pharmacological activity of BI 767551 in non-hospitalised patients with mild to moderate COVID-19 symptoms. The study was terminated early. 5 patients total participated in phase II and phase III was not conducted.

    Pre-assignment
    Screening details
    		 All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.

    Period 1
    Period 1 title
    Randomised
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor
    Blinding implementation details
    Patients, investigators, central reviewers, and everyone involved in trial conduct with exception of the pharmacist will remain double-blind with regard to the randomised treatment assignments.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo intravenous (i.v.) + placebo inhaled
    Arm description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Solvent for BI 767551
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Inhalation use
    Dosage and administration details
    A single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1.

    Investigational medicinal product name
    Sterile normal saline (NaCl 0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes on Day 1

    Arm title
    		 Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
    Arm description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 767551
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    A single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1.

    Investigational medicinal product name
    Sterile normal saline (NaCl 0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes on Day 1

    Number of subjects in period 1
    		Placebo intravenous (i.v.) + placebo inhaled Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
    Started
    4
    1
    Completed
    2
    1
    Not completed
    2
    0
         Not treated
    2
    -
    Period 2
    Period 2 title
    Treated
    Is this the baseline period?
    		 Yes [1]
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Carer, Data analyst, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo intravenous (i.v.) + placebo inhaled
    Arm description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Solvent for BI 767551
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solvent for solution for infusion
    Routes of administration
    Inhalation use
    Dosage and administration details
    A single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1.

    Investigational medicinal product name
    Sterile normal saline (NaCl 0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes on Day 1

    Arm title
    		 Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
    Arm description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BI 767551
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    A single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1.

    Investigational medicinal product name
    Sterile normal saline (NaCl 0.9%)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes on Day 1

    Notes
    [1] - Period 1 is not the baseline period. It is expected that period 1 will be the baseline period.
    Justification: The baseline characteristics were analyzed using treated participants.
    Number of subjects in period 2 [2]
    		Placebo intravenous (i.v.) + placebo inhaled Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
    Started
    2
    1
    Completed
    0
    1
    Not completed
    2
    0
         Consent withdrawn by subject
    1
    -
         Lost to follow-up
    1
    -
    Notes
    [2] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Baseline characteristics are based on patients who were randomised after successfully completing the screening period and received at least one dose of the trial medication.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Placebo intravenous (i.v.) + placebo inhaled
    Reporting group description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.

    Reporting group title
    Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
    Reporting group description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.

    Reporting group values
    		 Placebo intravenous (i.v.) + placebo inhaled Placebo intravenous (i.v.) + BI 767551 250 mg inhaled Total
    Number of subjects
    		 2 1 3
    Age categorical
    Treated set (TS): This subject set includes all subjects who received any amount of study drug.
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 2 1 3
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age Continuous
    Treated set (TS): This subject set includes all subjects who received any amount of study drug. The "9999" stands for "not applicable".
    Units: years
        arithmetic mean (standard deviation)
    		 35.5 ( 10.6 ) 37.0 ( 9999 ) -
    Sex: Female, Male
    Treated set (TS): This subject set includes all subjects who received any amount of study drug.
    Units: Participants
        Female
    		 2 1 3
        Male
    		 0 0 0
    Race (NIH/OMB)
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 0 0 0
        White
    		 2 1 3
        More than one race
    		 0 0 0
        Unknown or Not Reported
    		 0 0 0
    Ethnicity (NIH/OMB)
    Treated set (TS): This subject set includes all subjects who received any amount of study drug.
    Units: Subjects
        Hispanic or Latino
    		 2 0 2
        Not Hispanic or Latino
    		 0 1 1
        Unknown or Not Reported
    		 0 0 0
    Log-transformed Nasopharyngeal (NP) swab viral load at baseline
    Each viral load result indicates the number of virus copies in a milliliter, and the raw values were log-transformed, resulting in log10 viral load. The "9999" stands for "not applicable".
    Units: Log10 copies / milliliter
        arithmetic mean (standard deviation)
    		 5.24 ( 2.09 ) 7.32 ( 9999 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Placebo intravenous (i.v.) + placebo inhaled
    Reporting group description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.

    Reporting group title
    Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
    Reporting group description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.
    Reporting group title
    Placebo intravenous (i.v.) + placebo inhaled
    Reporting group description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.

    Reporting group title
    Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
    Reporting group description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.

    Primary: Phase II: Time-weighted change from baseline in viral shedding over 8 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR)

    		 Close Top of page
    End point title
    		 Phase II: Time-weighted change from baseline in viral shedding over 8 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR) [1]
    End point description
    Time-weighted change from baseline in viral shedding over 8 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR), defined as a absolute change from baseline in log10 viral load, is reported. The "9999" stands for "not applicable". Modified Intention-To-Treat set (mITT): This subject set includes all randomised subjects that received any amount of study drug and who have at least a measurable baseline value (above Lower limit of quantification (LLOQ)) and a second measurement in the first week (up to 7 days after drug intake) of SARS-CoV-2 RNA by site collected nasopharyngeal (NP) swab.
    End point type
    Primary
    End point timeframe
    Up to 8 days
    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: The endpoint was planned to explore descriptively.
    End point values
    		 Placebo intravenous (i.v.) + placebo inhaled Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
    Number of subjects analysed
    2
    1 [2]
    Units: Log10 copies / milliliter
        arithmetic mean (standard deviation)
    0.15 ( 1.25 )
    -2.84 ( 9999 )
    Notes
    [2] - "9999" stands for "not applicable".
    No statistical analyses for this end point

    Primary: Phase II: Time-weighted change from baseline in viral shedding over 29 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR)

    		 Close Top of page
    End point title
    		 Phase II: Time-weighted change from baseline in viral shedding over 29 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR) [3]
    End point description
    Time-weighted change from baseline in viral shedding over 29 days in site collected nasopharyngeal (NP) swabs by Quantitative Reverse Transcription Polymerase chain reaction (RT-qPCR), defined as a absolute change from baseline in log10 viral load, is reported. The "9999" stands for "not applicable". Modified Intention-To-Treat set (mITT): This subject set includes all randomised subjects that received any amount of study drug and who have at least a measurable baseline value (above Lower limit of quantification (LLOQ)) and a second measurement in the first week (up to 7 days after drug intake) of SARS-CoV-2 RNA by site collected nasopharyngeal (NP) swab.
    End point type
    Primary
    End point timeframe
    Up to 29 days
    Notes
    [3] - 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: The endpoint was planned to explore descriptively.
    End point values
    		 Placebo intravenous (i.v.) + placebo inhaled Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
    Number of subjects analysed
    2
    1 [4]
    Units: Log10 copies / milliliter
        arithmetic mean (standard deviation)
    -2.09 ( 1.60 )
    -4.18 ( 9999 )
    Notes
    [4] - "9999" stands for "not applicable".
    No statistical analyses for this end point

    Secondary: Phase II: Number of participants with loss of detection of Severe acute respiratory syndrome coronavirus 2 ribonucleic acid (SARS-CoV-2 RNA) by site collected NP swab at Day 4, 8, 15, 22 and 29

    		 Close Top of page
    End point title
    		 Phase II: Number of participants with loss of detection of Severe acute respiratory syndrome coronavirus 2 ribonucleic acid (SARS-CoV-2 RNA) by site collected NP swab at Day 4, 8, 15, 22 and 29
    End point description
    Number of participants with loss of detection of Severe acute respiratory syndrome coronavirus 2 ribonucleic acid (SARS-CoV-2 RNA) by site collected NP swab at Day 4, 8, 15, 22 and 29 is report. The "Yes" = loss of detection of SARS-CoV-2 RNA; "No" = SARS-CoV-2 RNA detected; "Missing" = not evaluable. Treated set (TS): This subject set includes all subjects who received any amount of study drug.
    End point type
    Secondary
    End point timeframe
    At Day 4, Day 8, Day 15, Day 22, and Day 29
    End point values
    		 Placebo intravenous (i.v.) + placebo inhaled Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
    Number of subjects analysed
    2
    1
    Units: Participants
        Day 4|Yes
    0
    0
        Day 4|No
    2
    1
        Day 4|Missing
    0
    0
        Day 8|Yes
    0
    0
        Day 8|No
    2
    1
        Day 8|Missing
    0
    0
        Day 15|Yes
    1
    1
        Day 15|No
    1
    0
        Day 15|Missing
    0
    0
        Day 22|Yes
    1
    0
        Day 22|No
    0
    0
        Day 22|Missing
    1
    1
        Day 29|Yes
    0
    0
        Day 29|No
    0
    0
        Day 29|Missing
    2
    1
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From dosing until end of 90-day follow-up period, up to 91 days.
    Adverse event reporting additional description
    Treated set (TS): This subject set includes all subjects who received any amount of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Placebo intravenous (i.v.) + BI 767551 250 mg inhaled
    Reporting group description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of 250 milligrams (mg) of BI 767551 administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.

    Reporting group title
    Placebo intravenous (i.v.) + placebo inhaled
    Reporting group description
    		 Single dose of sterile normal saline (NaCl 0.9%) used as placebo was administered as intravenous (i.v.) infusion over a period of 60 minutes plus a single inhaled of solvent for dilution of BI 767551 used as placebo for inhalation administered via inhalation through a mouthpiece (Aerogen® Ultra) using a mesh nebulizer (Aerogen® Solo) on Day 1, followed by a 90-day follow-up period. The inhalation procedure was to start approximately 25 min after the start of infusion.

    Serious adverse events
    		 Placebo intravenous (i.v.) + BI 767551 250 mg inhaled Placebo intravenous (i.v.) + placebo inhaled
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    0 / 2 (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: 5%
    Non-serious adverse events
    		 Placebo intravenous (i.v.) + BI 767551 250 mg inhaled Placebo intravenous (i.v.) + placebo inhaled
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    2 / 2 (100.00%)
    Investigations
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Gamma-glutamyltransferase increased
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 1 (100.00%)
    1 / 2 (50.00%)
         occurrences all number
    1
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1
    Infections and infestations
    Parotitis
         subjects affected / exposed
    0 / 1 (0.00%)
    1 / 2 (50.00%)
         occurrences all number
    0
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Apr 2021
    For Phase II, the number of planned patients in each treatment arm was increased from 40:40:40:20 to 50:50:50:50, and the randomisation ratio was changed from 2:2:2:1 to 1:1:1:2, in order to include more patients in the placebo intravenous (i.v.) + BI 767551 250 milligrams (mg) inhaled arm and reach an equal number of patients in each arm at the end of recruitment in Phase II. For Phase III, a treatment arm for inhaled trial drug was added as an option.

    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.
    This trial was prematurely discontinued due to sponsor decision. No patients were entered in the planned Phase II "BI 10 mg/kg intravenous (i.v.) + placebo inhaled" and "BI 40 mg/kg i.v. + placebo inhaled" groups. Phase III part was not conducted.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Wed May 08 17:40:00 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA