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    Clinical Trial Results:
    A Phase 2, Single-Center, Double-Blind, Placebo-Controlled, Study of PUL-042 Inhalation Solution in Rhinovirus-induced Symptoms in Current Smokers with Gold Stage 0 Chronic Obstructive Pulmonary Disease (COPD).

    Summary
    EudraCT number
    		 2018-002806-30
    Trial protocol
    		 GB  
    Global end of trial date
    16 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Apr 2022
    First version publication date
    21 Apr 2022
    Other versions
    Summary report(s)
    		 Summary Report (PUL-042-402)

    Trial information

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    Trial identification
    Sponsor protocol code
    PUL-042-402
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03794557
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Pulmotect, Inc.
    Sponsor organisation address
    3900 Essex Lane, Suite 575, Houston, United States, TX 77027
    Public contact
    Brenton Scott, PhD, Pulmotect, Inc., 1 713579-9226, bscott@pulmotect.com
    Scientific contact
    Brenton Scott, PhD, Pulmotect, Inc., 1 713579-9226, bscott@pulmotect.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
    14 Oct 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    16 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the effects of PUL-042 Inhalation Solution on peak lower respiratory symptom score in GOLD stage 0 COPD subjects with an experimentally introduced rhinovirus infection with laboratory human rhinovirus strain HRV A16. All subjects will be negative for serum neutralizing antibody to HRV A16 at screening prior to viral inoculation.
    Protection of trial subjects
    An external Data Safety Monitoring Board (DSMB) was used to evaluate safety of the study. There were three voting members. None of the voting members had any affiliation with Pulmotect, Inc. The DSMB reviewed study data on an ongoing basis as specified in the DSMB charter. The first cohort tested consisted of 2 subjects (1 active and 1 placebo) and was a sentinel group. The second cohort (2 active and 2 placebo) was not dosed until both subjects in the sentinel group had completed treatment through Day 21 and the Principal Investigator and the Medical Monitor agreed that dosing of the second cohort could proceed. The second cohort of 4 subjects (2 active and 2 placebo) was followed until all subjects completed Day 21. At that point, the DSMB reviewed the data from the first 6 subjects (3 active and 3 placebo) and was asked to make a recommendation to continue with the study, prior to any further subjects being dosed. The Principal Investigator or Medical Monitor could independently terminate the study at any time.
    Background therapy
    		 Current smokers with >10 pyh; Subject had risk of COPD defined by GOLD Staging Criteria level 0 where the subjects’ post-bronchodilator FEV1/FVC ratio >0.70 and FEV1 is >80% normal predicted;
    Evidence for comparator
    		 Not applicable - comparator was standard of care for the disease plus placebo.
    Actual start date of recruitment
    19 Nov 2018
    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
    United Kingdom: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were enrolled from 1 site, in 1 country: ICRRU, St Mary’s Hospital, London, United Kingdom. Screening of patients lasted from November 2018 to November 2020. The first patient was randomised on 21 January 2019, with the last patient being randomised in to the study 3 November 2020

    Pre-assignment
    Screening details
    		 In total 143 subjects were screened, 24 of which passed screening (16.8%). Potential subjects failed screening for a number of different reasons. There was not a trend in screening failure.

    Period 1
    Period 1 title
    Treatment period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    The pharmacy personnel at the clinical site were responsible for the preparation of the appropriate concentration of PUL-042. Members of the site team, responsible for administration and clinical assessment, were blinded. In addition, an unblinded monitor was employed to carry out the pharmacy visits and drug reconciliation, ensuring that the blinding of the monitor reviewing the clinical data was maintained.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Active
    Arm description
    		 Patients treated with active treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    PUL-042
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    20.3 μg Pam2 : 29.8 μg ODN administered 24 hours prior to inoculation with HRV A16 followed by a second dose of PUL-042 (20.3 μg Pam2 : 29.8 μg ODN) administered 48 hours post inoculation with HRV A16

    Arm title
    		 Placebo
    Arm description
    		 Patients treated with placebo treatment 24 hours prior to inoculation with HRV A16 followed by a second dose of placebo treatment administered 48 hours post inoculation with HRV A16
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to match PUL-042
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Placebo of equal volume to match PUL-042

    Number of subjects in period 1 [1]
    		Active Placebo
    Started
    11
    11
    Completed
    9
    10
    Not completed
    2
    1
         Consent withdrawn by subject
    1
    -
         Physician decision
    1
    -
         Adverse event, non-fatal
    -
    1
    Notes
    [1] - 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: 24 subjects passed screening. One subject was lost to follow up prior to randomisation. Another subject was withdrawn due to an investigator’s decision regarding an abnormal chest X-ray prior to dosing on Study Day -1. So, 23 were subsequently randomised, 22 of whom became the safety population.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Patients treated with active treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Patients treated with placebo treatment 24 hours prior to inoculation with HRV A16 followed by a second dose of placebo treatment administered 48 hours post inoculation with HRV A16

    Reporting group values
    		 Active Placebo Total
    Number of subjects
    		 11 11 22
    Age categorical
    Patient Age was collected at patient enrollment
    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)
    		 11 11 22
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Gender categorical
    Patient gender was collected at patient enrollment
    Units: Subjects
        Female
    		 4 4 8
        Male
    		 7 7 14

    End points

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    End points reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Patients treated with active treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Patients treated with placebo treatment 24 hours prior to inoculation with HRV A16 followed by a second dose of placebo treatment administered 48 hours post inoculation with HRV A16

    Subject analysis set title
    Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    Safety population

    Primary: Effects of PUL-042 Inhalation Solution on peak lower respiratory symptom score

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    End point title
    		 Effects of PUL-042 Inhalation Solution on peak lower respiratory symptom score
    End point description
    LRSS was measured repeatedly during each dosing day, by means of patients completing a questionnaire
    End point type
    Primary
    End point timeframe
    Pre-treatment to Day 14
    End point values
    		 Active Placebo
    Number of subjects analysed
    9
    9
    Units: LRSS
        arithmetic mean (standard deviation)
    5.11 ± 0.78
    5.00 ± 2.92
    Statistical analysis title
    		 Primary Statistical Analysis
    Statistical analysis description
    All statistical analysis was performed according to the Statistical Analysis Plan. Statistical analysis for the primary endpoints on the infected and evaluable population involved the use of analysis of co-variance (ANCOVA) to identify differences between placebo and PUL-042 treated subjects for all primary symptom score endpoints. The symptom scores were analysed firstly as actual values; additionally, data was analysed as adjusted from baseline which involved subtracting the baseline scores.
    Comparison groups
    Placebo v Active
    Number of subjects included in analysis
    18
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 ≤ 0.05 [2]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [1] - The ANCOVA analysis for the primary and secondary endpoints was shown as model estimates, reporting P-values for any treatment effect for significant differences between PUL-042 and placebo, and also for any baseline effect; whereby the baseline score was analysed as a co-variate, thus improving the efficiency of the analysis by reducing the variability (minimum variance unbiased estimator).
    [2] - A significant P-value for the baseline effect indicated that the ANCOVA had significantly reduced the experimental error variance for the baseline co-variate.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    AEs were recorded at each clinic visit from signing of the Informed Consent Form until completion of the End of Study visit (Day 42)
    Adverse event reporting additional description
    At every patient visit, patients were asked non-leading questions to determine the occurrence of AEs. In addition, all AEs reported spontaneously during the course of the clinical study were recorded.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22
    Reporting groups
    Reporting group title
    Active
    Reporting group description
    		 Patients receiving active treatment

    Reporting group title
    Placebo
    Reporting group description
    		 Patients receiving placebo treatment (placebo).

    Serious adverse events
    		 Active Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 11 (0.00%)
    0 / 11 (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: 0%
    Non-serious adverse events
    		 Active Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 11 (90.91%)
    10 / 11 (90.91%)
    Investigations
    Forced expiratory volume decreased
         subjects affected / exposed
    6 / 11 (54.55%)
    4 / 11 (36.36%)
         occurrences all number
    7
    5
    Nervous system disorders
    Headache
         subjects affected / exposed
    3 / 11 (27.27%)
    3 / 11 (27.27%)
         occurrences all number
    4
    4
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    2 / 11 (18.18%)
    3 / 11 (27.27%)
         occurrences all number
    2
    3

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Nov 2018
    The purpose of the submission was to provide an updated protocol for study PUL-042-402 (new protocol version 4; 7 November 2018). The clinical protocol was amended in version 4: the descriptions of the clinical blood tests being conducted, as these were variously referred to as Haematology and biochemistry, clinical laboratory (LFTs, haematology, Chemistry), or serum chemistry, in protocol PUL-042-402; Version 3, dated 25th October, 2018. The sponsor now referred to blood analytes (Na+, glucose etc.) as serum chemistry, identified liver function tests, serum CRP and haematology tests independently. This did not change the overall number of blood tests; just a more accurate reflection of what tests were to be performed and when. Other changes were editorial and non-substantial in nature.
    01 Jul 2019
    The purpose of the amendment was to provide PUL-042-402 (protocol version 5; 28th June, 2019). The active protocol provided for collection of vital signs at 15 minutes and 30 minutes post-dose on D-1 and D2 as represented in Table 2 ‘Schedule of Events’. This was not reflected in the corresponding wording in Section 7 of the main body of the protocol (specifically Sections 7.11.3 and 7.14.1). The Sponsor modified these paragraphs in Section 7, such that they corresponded with the ‘Schedule of Events’ appropriately. In addition, the Sponsor added Lower Respiratory Symptom Score (LRSS) diary completion at 15 minutes as well as at 30 minutes post-dose on D-1 and D2 to provide symptom information in tandem with vital signs. The DSMB was comfortable with this addition. The sponsor is also taking this opportunity to make some additional corrections/revisions to the protocol. These changes were editorial and non-substantial in nature.
    28 Oct 2019
    The purpose of the amendment was to provide PUL-042-402 protocol version 6; 22nd October, 2019. The changes included and increase of the Number of Subjects such that twenty four subjects would be enrolled. Twelve subjects would be randomised to each arm, to allow for additional potential unevaluable patients. In addition, the Study Drug Administration was updated to permit the use of a CE-marked facemask (PARI Adult Mask Soft or the PARI SMARTMASK) as an alternative to study drug administration by inhalation by mouth, both via a Pari Sprint nebulizer.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 Mar 2020
    1st wave of the COVID19 pandemic of 2020
    03 Aug 2020

    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
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