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    Clinical Trial Results:
    A Phase 2a, Randomised, Double-Blind, Placebo-Controlled, Two-Part Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetic Profiles of Inhaled Doses of NOC-100 in Adult Participants with Chronic Cough or Acute Cough, including Cough due to Postinfectious COVID-19

    Summary
    EudraCT number
    		 2020-004715-27
    Trial protocol
    		 DE  
    Global end of trial date
    06 Nov 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Dec 2024
    First version publication date
    14 Dec 2024
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    NOC100-C-201
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Nocion Therapeutics, Inc.
    Sponsor organisation address
    15 Main Street, #247, Watertown, United States, MA 02472
    Public contact
    Clinical Trials Information, Nocion Therapeutics, Inc., +1 617803 2445, clinicaltrials@nociontx.com
    Scientific contact
    Clinical Trials Information, Nocion Therapeutics, Inc., +1 617803 2445, clinicaltrials@nociontx.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 Jun 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    04 May 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Nov 2023
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Part 1: To evaluate the safety and tolerability of escalating nebulised inhaled doses of NOC 100 (single and 2 consecutive QD doses) in participants with chronic cough (CC). Part 2: To evaluate the treatment effect of nebulised inhaled doses of NOC 100 as determined by visual analogue scale (VAS) score for cough severity in participants with acute cough (AC). To evaluate the safety and tolerability of nebulised inhaled doses of NOC 100 in participants with AC.
    Protection of trial subjects
    Prior to initiation of any study-specific procedures, participants received a copy of the Informed Consent Form (ICF) that summarized, in non-technical terms, the purpose of the study, the procedures to be carried out, and the potential hazards. The Principal Investigators (PIs) or their representatives explained the nature of the study to the participants, in non-technical terms, and answered all questions regarding the study. Participants reviewed, signed, and dated the ICF. Participants received a copy of the fully signed ICF.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    29 Apr 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
    United Kingdom: 21
    Country: Number of subjects enrolled
    Germany: 20
    Worldwide total number of subjects
    41
    EEA total number of subjects
    20
    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)
    23
    From 65 to 84 years
    18
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Adult male and females with chronic cough were screened against the eligibility criteria between 28 to 7 days prior to Day -2.

    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, Monitor

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 NOC-100
    Arm description
    		 Subjects randomized to receive NOC-100
    Arm type
    		 Experimental

    Investigational medicinal product name
    NOC-100 Neubulized Solution
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    NOC-100 nebulized solution was administered via nebulizer for 2 consecutive days at each of 3 dose levels sequentially with 4 days wash-out in between.

    Arm title
    		 Placebo
    Arm description
    		 Subjects randomized to receive placebo.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Matching placebo nebulized solution was administered via nebulizer for 2 consecutive days at each of 3 dosing periods with 4 days wash-out in between.

    Number of subjects in period 1
    		NOC-100 Placebo
    Started
    41
    38
    Completed
    37
    37
    Not completed
    4
    1
         Physician decision
    1
    -
         Consent withdrawn by subject
    1
    -
         Adverse event, non-fatal
    2
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 -

    Reporting group values
    		 Overall study Total
    Number of subjects
    		 41 41
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 59.7 ( 10.91 ) -
    Gender categorical
    Units: Subjects
        Female
    		 37 37
        Male
    		 4 4

    End points

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    End points reporting groups
    Reporting group title
    NOC-100
    Reporting group description
    		 Subjects randomized to receive NOC-100

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomized to receive placebo.

    Primary: Adverse events

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    End point title
    		 Adverse events [1]
    End point description
    End point type
    Primary
    End point timeframe
    Treatment Emergent Adverse Events were recorded from first dose until last study visit.
    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: Per protocol, the primary endpoint was the incidence of safety events, consequently, no additional formal statistical analyses were performed on primary endpoint data in this early phase study.
    End point values
    		 NOC-100 Placebo
    Number of subjects analysed
    41
    38
    Units: Subjects
        Subjects with TEAEs
    20
    16
        Subjects without TEAEs
    21
    22
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first dose to end of study visit.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23.1
    Reporting groups
    Reporting group title
    NOC-100
    Reporting group description
    		 Subjects randomized to receive NOC-100

    Reporting group title
    Placebo
    Reporting group description
    		 Subjects randomized to receive placebo

    Serious adverse events
    		 NOC-100 Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 41 (0.00%)
    0 / 38 (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
    		 NOC-100 Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 41 (48.78%)
    16 / 38 (42.11%)
    Injury, poisoning and procedural complications
    Joint dislocation
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Ligament sprain
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Vascular disorders
    Hypotension
         subjects affected / exposed
    1 / 41 (2.44%)
    2 / 38 (5.26%)
         occurrences all number
    1
    2
    Phlebitis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 38 (2.63%)
         occurrences all number
    1
    1
    Bradycardia
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Supraventricular extrasystoles
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Supraventricular tachycardia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Nervous system disorders
    Head discomfort
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    6 / 41 (14.63%)
    4 / 38 (10.53%)
         occurrences all number
    6
    4
    Migraine
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Presyncope
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Tension headache
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Catheter site swelling
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Malaise
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 38 (2.63%)
         occurrences all number
    1
    1
    Dysphagia
         subjects affected / exposed
    0 / 41 (0.00%)
    2 / 38 (5.26%)
         occurrences all number
    0
    2
    Enteritis
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Haematochezia
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    2 / 41 (4.88%)
    1 / 38 (2.63%)
         occurrences all number
    2
    1
    Paraesthesia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Salivary hypersecretion
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Stomatitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    4 / 41 (9.76%)
    0 / 38 (0.00%)
         occurrences all number
    4
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    11 / 41 (26.83%)
    11 / 38 (28.95%)
         occurrences all number
    11
    11
    Pharyngeal hypoaesthesia
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Pharyngeal paraesthesia
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Pollakiuria
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 41 (2.44%)
    1 / 38 (2.63%)
         occurrences all number
    1
    1
    Periarthritis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Limb discomfort
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Infections and infestations
    Abscess
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    asymptomatic COVID-19
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    2 / 41 (4.88%)
    0 / 38 (0.00%)
         occurrences all number
    2
    0
    Cystitis
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 41 (2.44%)
    0 / 38 (0.00%)
         occurrences all number
    1
    0
    Viral upper respiratory tract infection
         subjects affected / exposed
    0 / 41 (0.00%)
    1 / 38 (2.63%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Jan 2021
    Version 2 of the study protocol was prepared to address comments and recommendations of the BfArM and Ethics.
    05 Feb 2021
    Version 3 of the study protocol was prepared to address comments and recommendations of the BfArM and Ethics.
    05 Nov 2021
    Version 4 of the protocol was requested by the Sponsor and included updates to the following: study contacts, number of study participants, washout duration, safety assessments, inclusion and exclusion criteria, and Bitrex(R) administration.

    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.
    The number of occurrences of each adverse event was not detailed in the Clinical Study Report - this has been entered as equal to the number of subjects reporting each event.
    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.

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