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    Clinical Trial Results:
    A randomized, subject- and investigator-blinded, placebo-controlled study to assess the efficacy and safety of LOU064 in patients with inadequately controlled asthma

    Summary
    EudraCT number
    		 2018-003609-24
    Trial protocol
    		 PL  
    Global end of trial date
    27 Apr 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    15 Apr 2021
    First version publication date
    15 Apr 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CLOU064D12201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03944707
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH-4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.com
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, 41 613241111, Novartis.email@novartis.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
    27 Apr 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    27 Apr 2020
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    This proof-of-concept study investigated the efficacy and safety of LOU064 in patients with inadequately controlled asthma who were on a standardized background therapy of inhaled corticosteroid plus long acting beta-2 agonist (ICS/LABA). The primary objective of the study was to determine the efficacy of LOU064 compared to placebo with respect to change from baseline in pre-dose FEV1 (forced expiratory volume in one second) at Week 12.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial. As a rescue medication, all subjects were supplied with an inhaled short-acting beta2-agonist (SABA): 100 μg/puff salbutamol or other SABA at matching dose strength, corresponding to albuterol 90 μg/puff.
    Background therapy
    		 All participants received a standardized background therapy of budesonide 80 μg/formoterol 4.5 μg two inhalations twice a day (b.i.d) beginning at the run-in visit through the end of study visit.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Jul 2019
    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
    Argentina: 8
    Country: Number of subjects enrolled
    Germany: 16
    Country: Number of subjects enrolled
    Poland: 11
    Country: Number of subjects enrolled
    Russian Federation: 12
    Country: Number of subjects enrolled
    United States: 29
    Worldwide total number of subjects
    76
    EEA total number of subjects
    27
    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)
    68
    From 65 to 84 years
    8
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants took part in 19 investigative sites in 5 countries.

    Pre-assignment
    Screening details
    		 After the screening, participants went through a Run-in period of 3-5 weeks where they discontinued their current asthma therapy and were placed on budesonide 80 μg/formoterol 4.5 μg delivered by dry powder inhaler. Afterwards, patients were randomized in 3:2 ratio to receive LOU064 or placebo and continued to use the budesonide/formoterol inhaler.

    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
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 LOU064
    Arm description
    		 LOU064 100 mg once daily orally
    Arm type
    		 Experimental

    Investigational medicinal product name
    LOU064
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    LOU064 100 mg once daily orally administered as two 50 mg capsules.

    Arm title
    		 Placebo
    Arm description
    		 Placebo once daily orally
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Placebo once daily administered orally as capsules

    Number of subjects in period 1
    		LOU064 Placebo
    Started
    47
    29
    PK analysis set
    33 [1]
    0 [2]
    PD analysis set
    47
    29
    Completed
    35
    19
    Not completed
    12
    10
         Adverse event, non-fatal
    -
    2
         Subject decision
    -
    1
         Study terminated by sponsor
    12
    7
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The intermediate milestones refer to the analysis sets
    [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The intermediate milestones refer to the analysis sets.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    LOU064
    Reporting group description
    		 LOU064 100 mg once daily orally

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily orally

    Reporting group values
    		 LOU064 Placebo Total
    Number of subjects
    		 47 29 76
    Age categorical
    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)
    		 41 27 68
        From 65-84 years
    		 6 2 8
        85 years and over
    		 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 49.2 ± 10.96 53.2 ± 10.40 -
    Sex: Female, Male
    Units: participants
        Female
    		 28 22 50
        Male
    		 19 7 26
    Race/Ethnicity, Customized
    Units: Subjects
        Caucasian
    		 42 27 69
        Black
    		 4 2 6
        Asian
    		 1 0 1

    End points

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    End points reporting groups
    Reporting group title
    LOU064
    Reporting group description
    		 LOU064 100 mg once daily orally

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily orally

    Primary: Change from baseline in pre-dose FEV1 at Week 12

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    End point title
    		 Change from baseline in pre-dose FEV1 at Week 12
    End point description
    FEV1 (forced expiratory volume in one second) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing. Pre-dose FEV1 is defined as average of the two FEV1 measurements taken 45 min and 15 min pre-dose. The baseline pre-dose FEV1 is defined as the average of the FEV1 measurements performed 45 min and 15 min prior to dosing on Day 1. A positive change from baseline in pre-dose FEV1 is considered a favorable outcome. Change from baseline in pre-dose FEV1 was analyzed using a Bayesian model for repeated measures, adjusting for effects of treatment*visit interaction and baseline pre-dose FEV1. A weakly informative prior was considered for the placebo response.
    End point type
    Primary
    End point timeframe
    Baseline, Week 12
    End point values
    		 LOU064 Placebo
    Number of subjects analysed
    32
    20
    Units: liters
        arithmetic mean (standard deviation)
    0.105 ± 0.0494
    0.075 ± 0.0497
    Statistical analysis title
    		 LOU064 vs Placebo
    Comparison groups
    LOU064 v Placebo
    Number of subjects included in analysis
    52
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6643 [1]
    Method
    		 Bayesian model for repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.03
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.06
         upper limit
    		 0.119
    Variability estimate
    Standard deviation
    Dispersion value
    0.0698
    Notes
    [1] - Probability LOU064 better than placebo

    Secondary: Maximum observed blood concentrations (Cmax) of LOU064 at steady state

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    End point title
    		 Maximum observed blood concentrations (Cmax) of LOU064 at steady state
    End point description
    Pharmacokinetic (PK) parameters were calculated based on LOU064 blood concentrations determined by a validated liquid chromatography and tandem mass spectrometry (LC-MS/MS) method with a lower limit of quantification of 1 ng/mL. Cmax was determined using non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    pre-dose, 0.5, 1, 2, 3 and 4 hours after dosing on Days 15 and 85
    End point values
    		 LOU064 Placebo
    Number of subjects analysed
    33
    0 [2]
    Units: ng/mL
    arithmetic mean (standard deviation)
        Day 15 (n = 32, 0)
    239 ± 152
    ±
        Day 85 (n = 22, 0)
    222 ± 142
    ±
    Notes
    [2] - Pharmacokinetic parameters were not calculated in the Placebo arm.
    No statistical analyses for this end point

    Secondary: Time to reach maximum blood concentrations (Tmax) of LOU064 at steady state

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    End point title
    		 Time to reach maximum blood concentrations (Tmax) of LOU064 at steady state
    End point description
    PK parameters were calculated based on LOU064 blood concentrations determined by a validated LC-MS/MS method with a lower limit of quantification of 1 ng/mL. Tmax was determined using non-compartmental methods.
    End point type
    Secondary
    End point timeframe
    pre-dose, 0.5, 1, 2, 3 and 4 hours after dosing on Days 15 and 85
    End point values
    		 LOU064 Placebo
    Number of subjects analysed
    33
    0 [3]
    Units: hours (hr)
    median (full range (min-max))
        Day 15 (n = 32, 0)
    1.00 (0.483 to 2.00)
    ( to )
        Day 85 (n = 22, 0)
    1.00 (0.500 to 3.00)
    ( to )
    Notes
    [3] - Pharmacokinetic parameters were not calculated in the Placebo arm.
    No statistical analyses for this end point

    Secondary: Area under the concentration-time curve from time zero to 24 hours (AUC0-24h) of LOU064 at steady state

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    End point title
    		 Area under the concentration-time curve from time zero to 24 hours (AUC0-24h) of LOU064 at steady state
    End point description
    PK parameters were calculated based on LOU064 blood concentrations determined by a validated LC-MS/MS method with a lower limit of quantification of 1 ng/mL. AUC0-24h was determined using non-compartmental methods. The linear trapezoidal rule was used for AUC0-24h calculation.
    End point type
    Secondary
    End point timeframe
    pre-dose, 0.5, 1, 2, 3 and 4 hours after dosing on Days 15 and 85
    End point values
    		 LOU064 Placebo
    Number of subjects analysed
    33
    0 [4]
    Units: hr*ng/mL
    arithmetic mean (standard deviation)
        Day 15 (n = 21, 0)
    471 ± 285
    ±
        Day 85 (n = 16, 0)
    517 ± 342
    ±
    Notes
    [4] - Pharmacokinetic parameters were not calculated in the Placebo arm.
    No statistical analyses for this end point

    Secondary: Change from baseline in Asthma Symptom Questionnaire-5 score (ACQ-5) at Week 12

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    End point title
    		 Change from baseline in Asthma Symptom Questionnaire-5 score (ACQ-5) at Week 12
    End point description
    The ACQ-5 is a five-item, self-completed questionnaire, which is used as a measure of asthma control of a participant. Patients were asked to recall how their asthma had been during the previous week and to respond to the symptom questions on a 7-point scale (0=no impairment, 6=maximum impairment). The questions are equally weighted and the overall ACQ-5 score is the mean of all 5 questions, therefore between 0 (totally controlled) and 6 (severely uncontrolled). The baseline values of ACQ-5 were collected at the baseline visit. A negative change from baseline in ACQ-5 is considered a favorable outcome. Change from baseline in ACQ-5 score was analyzed using a Bayesian model for repeated measures, adjusting for effects of treatment*visit interaction and baseline ACQ-5 score. Non-informative priors were considered.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12
    End point values
    		 LOU064 Placebo
    Number of subjects analysed
    33
    20
    Units: score on scale
        arithmetic mean (standard deviation)
    -0.95 ± 0.133
    -0.86 ± 0.164
    Statistical analysis title
    		 LOU064 vs Placebo
    Comparison groups
    LOU064 v Placebo
    Number of subjects included in analysis
    53
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6609 [5]
    Method
    		 Bayesian model for repeated measures
    Parameter type
    		 Median difference (net)
    Point estimate
    -0.09
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.35
         upper limit
    		 0.18
    Variability estimate
    Standard deviation
    Dispersion value
    0.21
    Notes
    [5] - Probability LOU064 better than placebo

    Secondary: Change from baseline in mean morning and mean evening Peak Expiratory Flow (PEF)

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    End point title
    		 Change from baseline in mean morning and mean evening Peak Expiratory Flow (PEF)
    End point description
    PEF (Peak Expiratory Flow) is a person's maximum speed of expiration. All participants were instructed to record PEF twice daily before taking any medication using an electronic peak expiratory flow device (ePEF), once in the morning and once approximately 12 h later in the evening at home. At each timepoint, the participant was instructed to perform 3 consecutive manoeuvres within 10 minutes. These PEF values were captured in the e-PEF/diary. For each day the best value in the morning and in the evening were considered and mean values on 4-week intervals were derived. The baseline values of PEF were the mean values in the run-in period. A positive change from baseline in PEF is considered a favorable outcome. Change from baseline in mean morning and mean evening PEF were analyzed using a Bayesian model for repeated measures, adjusting for effects of treatment*weeks interaction and baseline PEF values. Non-informative priors were considered.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 9-12
    End point values
    		 LOU064 Placebo
    Number of subjects analysed
    47
    29
    Units: liters/minute
    arithmetic mean (standard deviation)
        Change in mean morning PEF (n = 29, 18)
    -2.4 ± 4.30
    -2.6 ± 5.59
        Change in mean evening PEF (n = 28, 18)
    -9.7 ± 5.58
    -6.3 ± 7.23
    Statistical analysis title
    		 LOU064 vs Placebo
    Statistical analysis description
    Change from baseline in mean morning PEF
    Comparison groups
    LOU064 v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.5107 [6]
    Method
    		 Bayesian model for repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.1
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -9
         upper limit
    		 9.1
    Variability estimate
    Standard deviation
    Dispersion value
    7.13
    Notes
    [6] - Probability LOU064 better than placebo
    Statistical analysis title
    		 LOU064 vs Placebo
    Statistical analysis description
    Change from baseline in mean evening PEF
    Comparison groups
    LOU064 v Placebo
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3611 [7]
    Method
    		 Bayesian model for repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    -3.4
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -15.2
         upper limit
    		 8.1
    Variability estimate
    Standard deviation
    Dispersion value
    9.15
    Notes
    [7] - Probability LOU064 better than placebo

    Secondary: Change from baseline in number of puffs of SABA taken per day during the treatment period

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    End point title
    		 Change from baseline in number of puffs of SABA taken per day during the treatment period
    End point description
    Participants were given a short acting β2-agonist (SABA; salbutamol, known also as albuterol) to use as rescue medication throughout the study along with an electronic diary (eDiary) to record rescue medication use. Participants recorded in the eDiary, once in the morning and once in the evening, the use of rescue medication (number of puffs of SABA taken in the previous 12 hours). The total number of puffs of SABA taken per day was calculated and the mean daily use of puffs of SABA over 12 weeks was derived. The baseline values of number of puffs of SABA taken per day were defined as the average from all non-missing records taken during the run-in period. A negative change from baseline is considered a favorable outcome. Change from baseline in number of puffs of SABA taken per day was analyzed using a Bayesian model, adjusting for effects of baseline SABA use, baseline FEV1, baseline asthma daytime symptom score and treatment. Non-informative priors were considered.
    End point type
    Secondary
    End point timeframe
    Baseline, 12 weeks
    End point values
    		 LOU064 Placebo
    Number of subjects analysed
    41
    26
    Units: puffs of SABA
        arithmetic mean (standard deviation)
    -0.192 ± 0.0946
    -0.059 ± 0.1224
    Statistical analysis title
    		 LOU064 vs Placebo
    Comparison groups
    LOU064 v Placebo
    Number of subjects included in analysis
    67
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.8022 [8]
    Method
    		 Bayesian model
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.133
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.336
         upper limit
    		 0.071
    Variability estimate
    Standard deviation
    Dispersion value
    0.1588
    Notes
    [8] - Probability LOU064 better than placebo

    Secondary: Change from baseline in daytime and nighttime asthma symptom score

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    End point title
    		 Change from baseline in daytime and nighttime asthma symptom score
    End point description
    Participants recorded asthma symptoms twice daily in the eDiary. Daytime asthma symptoms were assessed before bed and nighttime symptoms on awakening. Daytime asthma symptom score included 4 questions. Overall score (0 to 6) was calculated as the average of the 4 questions with higher values indicating more asthma symptoms. Nighttime asthma symptom score included 2 questions. Overall score (0 to 3.5) was calculated as the average of the 2 questions with higher values indicating more asthma symptoms. Mean values of both scores were calculated over 4-week intervals during the treatment period. The baseline values of both asthma symptoms scores were defined as the average score during the run-in period. A negative change from baseline is a favorable outcome. Change from baseline in daytime and nighttime asthma symptom score were analyzed using a Bayesian model for repeated measures, adjusting for effects of treatment*weeks and baseline scores. Non-informative priors were considered.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 9-12
    End point values
    		 LOU064 Placebo
    Number of subjects analysed
    34
    20
    Units: score on scale
    arithmetic mean (standard deviation)
        Change in daytime asthma symptom score
    -0.225 ± 0.0962
    -0.175 ± 0.1237
        Change in nighttime asthma symptom score
    -0.120 ± 0.0488
    -0.195 ± 0.0651
    Statistical analysis title
    		 LOU064 vs Placebo
    Statistical analysis description
    Change from baseline in daytime asthma symptom score
    Comparison groups
    LOU064 v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.6312 [9]
    Method
    		 Bayesian model for repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    -0.05
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.251
         upper limit
    		 0.149
    Variability estimate
    Standard deviation
    Dispersion value
    0.1573
    Notes
    [9] - Probability LOU064 better than placebo
    Statistical analysis title
    		 LOU064 vs Placebo
    Statistical analysis description
    Change from baseline in nighttime asthma symptom score
    Comparison groups
    LOU064 v Placebo
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1752 [10]
    Method
    		 Bayesian model for repeated measures
    Parameter type
    		 Mean difference (net)
    Point estimate
    0.075
    Confidence interval
         level
    		 80%
         sides
    2-sided
         lower limit
    		 -0.028
         upper limit
    		 0.18
    Variability estimate
    Standard deviation
    Dispersion value
    0.0819
    Notes
    [10] - Probability LOU064 better than placebo

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study treatment until last dose of study treatment plus 30 days post treatment, up to Day 115.
    Adverse event reporting additional description
    Any sign or symptom that occurs during the study treatment plus 30 days post treatment.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.1
    Reporting groups
    Reporting group title
    LOU064
    Reporting group description
    		 LOU064 100 mg once daily orally

    Reporting group title
    Placebo
    Reporting group description
    		 Placebo once daily orally

    Serious adverse events
    		 LOU064 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 47 (0.00%)
    0 / 29 (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
    		 LOU064 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 47 (17.02%)
    10 / 29 (34.48%)
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 47 (0.00%)
    2 / 29 (6.90%)
         occurrences all number
    0
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    4 / 47 (8.51%)
    6 / 29 (20.69%)
         occurrences all number
    4
    9
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 47 (8.51%)
    4 / 29 (13.79%)
         occurrences all number
    5
    4

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    09 May 2019
    The purpose of this protocol amendment was to address the recommendation from the US-Health Authority FDA to adjust the dose of standard background medication of inhaled budesonide/formoterol to labeled dose for the therapy of asthma. In addition, the sample size for the study was reduced from 110 to 75 subjects available for analysis.

    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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