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    Clinical Trial Results:
    The utility of feNO in the differential diagnosis of chronic cough: The response to anti-inflammatory therapy with prednisolone and montelukast

    Summary
    EudraCT number
    		 2015-001736-38
    Trial protocol
    		 GB  
    Global end of trial date
    09 Mar 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Sep 2019
    First version publication date
    21 Sep 2019
    Other versions
    Summary report(s)
    		 Trial Summery
    Article 1
    Abstract
    Abstract

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    Academed100215
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02479074
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Hull and East Yorkshire Hospitals NHS trust
    Sponsor organisation address
    Casle Road, Cottingham , United Kingdom,
    Public contact
    Mahboobeh Haji Sadeghi, Hull and East Yorkshire Hospitals NHS trust, 0044 1482 624009, Mahboobeh.HajiSadeghi@hyms.ac.uk
    Scientific contact
    Mahboobeh Haji Sadeghi, Hull and East Yorkshire Hospitals NHS trust, 0044 1482 624009, Mahboobeh.HajiSadeghi@hyms.ac.uk
    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
    17 Apr 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    08 Mar 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine the difference in 24 hr cough counts measured using the Hull Automated Cough Counter (HACC), from baseline and after two weeks and four weeks treatment with either montelukast or prednisolone followed by montelukast in patients with FeNO≥30 ppb at screening or montelukast in patients with normal NO measurement of ≤20 ppb.
    Protection of trial subjects
    All the measurements has been followed according the approved SOP and a study doctor was available during the visits if it was needed.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Jun 2015
    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: 50
    Worldwide total number of subjects
    50
    EEA total number of subjects
    50
    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)
    38
    From 65 to 84 years
    12
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 50 non-asthmatic patients with chronic cough were recruited sequentially from a specialist cough clinic. 30 patients with FeNO ≥30ppb were randomised to either two weeks prednisolone 20mg or two weeks montelukast 10mg followed by montelukast 10mg for the subsequent two weeks. 20 patients with low FeNO ≤20 received four weeks montelukast.

    Pre-assignment
    Screening details
    		 Patients with a history of chronic cough at least 8 weeks duration were included. Subjects with the following criteria were excluded ; current diagnosis of classic asthma, any significant concomitant disease, a lower respiratory tract infection in the last 4 weeks, subjects who were taking ACE and current smokers.

    Period 1
    Period 1 title
    V1
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Blinding was not applicable to the period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 First Arm, High FeNO
    Arm description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the first Arm High FeNO were received 4 weeks Montelukast.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Four weeks montelukast 10mg once daily.

    Arm title
    		 Second Arm High FeNO
    Arm description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the second Arm High FeNO were received two weeks prednisolone 20mg tablets followed by two weeks montelukast 10 mg film-coated tablets.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prednisolone & Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two weeks prednisolone 20mg once a day followed by two weeks Montelukast 10mg per day.

    Arm title
    		 Low FeNO
    Arm description
    		 A control group of 20 patients with low FeNO (≤20 ppb) were enrolled who received four weeks Montelukast 10 mg.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Four weeks montelukast 10mg once daily.

    Number of subjects in period 1 [1]
    		First Arm, High FeNO Second Arm High FeNO Low FeNO
    Started
    15
    15
    20
    Baseline
    15
    15
    20
    Completed
    15
    14
    20
    Not completed
    0
    1
    0
         Transferred to other arm/group
    -
    1
    -
    Notes
    [1] - The number of subjects transferring in and out of the arms in the period are not the same. It is expected the net number of transfers in and out of the arms in a period, will be zero.
    Justification: In the Second arm high FeNO one of the subjects was wrongly randomized to the High FeNO group while the subject had a Low FeNO. Therefore transferred to the low FeNO group. 15 subject randomized to the second arm hifg FeNO group but only 14 subjects completed the baseline visit.
    Period 2
    Period 2 title
    V3
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The blinding was not applicable to the period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 First Arm, High FeNO
    Arm description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the first Arm High FeNO were received 4 weeks Montelukast.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Four weeks montelukast 10mg once daily.

    Arm title
    		 Second Arm High FeNO
    Arm description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the second Arm High FeNO were received two weeks prednisolone 20mg tablets followed by two weeks montelukast 10 mg film-coated tablets.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prednisolone & Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two weeks prednisolone 20mg once a day followed by two weeks Montelukast 10mg per day.

    Arm title
    		 Low FeNO
    Arm description
    		 A control group of 20 patients with low FeNO (≤20 ppb) were enrolled who received four weeks Montelukast 10 mg.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Four weeks montelukast 10mg once daily.

    Number of subjects in period 2 [2]
    		First Arm, High FeNO Second Arm High FeNO Low FeNO
    Started
    14
    14
    20
    Two weeks therapy
    14
    14
    20
    Completed
    14
    14
    20
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: In the second period after two weeks therapy in first arm 14, second arm 14 and third arm 20 patients completed the visit. One subject from third arm was withdraw from the study.
    Period 3
    Period 3 title
    V5
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    The blinding was not applicable to the period.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 First Arm, High FeNO
    Arm description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the first Arm High FeNO were received 4 weeks Montelukast.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Four weeks montelukast 10mg once daily.

    Arm title
    		 Second Arm High FeNO
    Arm description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the second Arm High FeNO were received two weeks prednisolone 20mg tablets followed by two weeks montelukast 10 mg film-coated tablets.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Prednisolone & Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Two weeks prednisolone 20mg once a day followed by two weeks Montelukast 10mg per day.

    Arm title
    		 Low FeNO
    Arm description
    		 A control group of 20 patients with low FeNO (≤20 ppb) were enrolled who received four weeks Montelukast 10 mg.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Montelukast
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Four weeks montelukast 10mg once daily.

    Number of subjects in period 3 [3]
    		First Arm, High FeNO Second Arm High FeNO Low FeNO
    Started
    14
    14
    19
    Four weeks therapy
    14
    14
    19
    Completed
    14
    14
    19
    Notes
    [3] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: In the end of the study after four weeks therapy in first arm 14, second arm 14 and third arm 19 patients completed the study.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    V1
    Reporting group description
    		 -

    Reporting group values
    		 V1 Total
    Number of subjects
    		 50 50
    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
    Average (± SD) age of the subjects studied was 62 ± 9.5 (range, 45-82 years).
    Units: years
        arithmetic mean (standard deviation)
    		 62 ( 9.5 ) -
    Gender categorical
    33 patients (65%) of the subjects were female while only 17 patients (35%) of the subjects were male.
    Units: Subjects
        Female
    		 33 33
        Male
    		 17 17

    End points

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    End points reporting groups
    Reporting group title
    First Arm, High FeNO
    Reporting group description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the first Arm High FeNO were received 4 weeks Montelukast.

    Reporting group title
    Second Arm High FeNO
    Reporting group description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the second Arm High FeNO were received two weeks prednisolone 20mg tablets followed by two weeks montelukast 10 mg film-coated tablets.

    Reporting group title
    Low FeNO
    Reporting group description
    		 A control group of 20 patients with low FeNO (≤20 ppb) were enrolled who received four weeks Montelukast 10 mg.
    Reporting group title
    First Arm, High FeNO
    Reporting group description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the first Arm High FeNO were received 4 weeks Montelukast.

    Reporting group title
    Second Arm High FeNO
    Reporting group description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the second Arm High FeNO were received two weeks prednisolone 20mg tablets followed by two weeks montelukast 10 mg film-coated tablets.

    Reporting group title
    Low FeNO
    Reporting group description
    		 A control group of 20 patients with low FeNO (≤20 ppb) were enrolled who received four weeks Montelukast 10 mg.
    Reporting group title
    First Arm, High FeNO
    Reporting group description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the first Arm High FeNO were received 4 weeks Montelukast.

    Reporting group title
    Second Arm High FeNO
    Reporting group description
    		 Following baseline assessments 30 eligible subjects with FeNO≥30 were randomized in a 1:1 ratio to receive either two weeks montelukast 10mg film-coated tablets or prednisolone 20mg tablets followed by montelukast 10 mg film-coated tablets for the subsequent two weeks in both arms. Allocation was performed by Research & Development Department based on a balanced block randomisation scheme, which was prepared using computerised system – sealed envelope, which was prepared using computerised system – sealed envelope. Subject in the second Arm High FeNO were received two weeks prednisolone 20mg tablets followed by two weeks montelukast 10 mg film-coated tablets.

    Reporting group title
    Low FeNO
    Reporting group description
    		 A control group of 20 patients with low FeNO (≤20 ppb) were enrolled who received four weeks Montelukast 10 mg.

    Primary: Number of coughs in 24 hours

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    End point title
    		 Number of coughs in 24 hours
    End point description
    Compared changes in 24 hours cough counting (using the Hull Automated Cough Counter (HACC)) at baseline after 2 and 4 weeks treatment between three treatment groups with an associated elevated FeNO was the primary endpoint.
    End point type
    Primary
    End point timeframe
    In the baseline after 2 and 4 weeks treatment
    End point values
    		 First Arm, High FeNO Second Arm High FeNO Low FeNO
    Number of subjects analysed
    10
    14
    17
    Units: Numbers
        V1
    292
    237
    566
        V3
    173
    89
    449
        V5
    150
    114
    265
    Statistical analysis title
    		 Number of cough in 24 hours
    Statistical analysis description
    Repeated measures ANCOVA was used to compare changes in the number of coughs in 24 hr at baseline, after 2 and 4 weeks treatment between high FeNO treatment groups and low FeNO treatment group.
    Comparison groups
    First Arm, High FeNO v Second Arm High FeNO v Low FeNO
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.005 [1]
    Method
    		 ANCOVA
    Confidence interval
    Notes
    [1] - P<0.005

    Secondary: Hull Airways Reflux Questionnaire (HARQ) score

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    End point title
    		 Hull Airways Reflux Questionnaire (HARQ) score
    End point description
    Subjective measures of cough were compared using the Hull Airways Reflux Questionnaire (HARQ) and Leicester Cough Questionnaire (LCQ) between the treatment groups at the baseline and after 2 week and 4 weeks treatment.
    End point type
    Secondary
    End point timeframe
    At the baseline and after 2 week and 4 weeks treatment.
    End point values
    		 First Arm, High FeNO Second Arm High FeNO Low FeNO
    Number of subjects analysed
    10
    14
    17
    Units: Numbers
        V1
    33
    27
    40
        V3
    23
    14
    37
        V5
    20
    15
    31
    Statistical analysis title
    		 HARQ score
    Statistical analysis description
    Repeated measures ANCOVA was used to compare changes in HARQ score at baseline, after 2 and 4 weeks treatment between high FeNO treatment groups and low FeNO treatment group.
    Comparison groups
    First Arm, High FeNO v Second Arm High FeNO v Low FeNO
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.005
    Method
    		 ANCOVA
    Confidence interval

    Secondary: Leicester Cough Questionnaire (LCQ)

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    End point title
    		 Leicester Cough Questionnaire (LCQ)
    End point description
    Subjective measures of cough were compared using the Hull Airways Reflux Questionnaire (HARQ) and Leicester Cough Questionnaire (LCQ) between the treatment groups at the baseline and after 2 week and 4 weeks treatment.
    End point type
    Secondary
    End point timeframe
    At the baseline and after 2 week and 4 weeks treatment.
    End point values
    		 First Arm, High FeNO Second Arm High FeNO Low FeNO
    Number of subjects analysed
    10
    14
    17
    Units: Number
        V1
    14
    15
    12
        V3
    15
    18
    14
        V5
    16
    17
    15
    Statistical analysis title
    		 LCQ
    Statistical analysis description
    Repeated measures ANCOVA was used to compare changes in the number of coughs in 24 hr, sputum eosinophil cell count, spirometry measurements, HARQ and LCQ score at baseline, after 2 and 4 weeks treatment between high FeNO treatment groups and low FeNO treatment group.
    Comparison groups
    First Arm, High FeNO v Second Arm High FeNO v Low FeNO
    Number of subjects included in analysis
    41
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 < 0.005
    Method
    		 ANCOVA
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The AE reporting period for this trial begins as soon as patients have consented to the trial and ends 30 days after the patients final study medication visit. The health status of subjects were checked at each study visit.
    Adverse event reporting additional description
    The investigator recorded all directly observed AEs and all AEs spontaneously reported by the trial subject. All adverse events were recorded by the investigator in patients data collection forms (CRFs) using R&D’s adverse event report form. All adverse events were recorded by the investigator in patients’ medical notes.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    First arm High FeNO
    Reporting group description
    		 This group of subjects received four weeks Montelukast 10mg daily.

    Reporting group title
    Second arm High FeNO
    Reporting group description
    		 Subjects in this group received two weeks prednisolone 20mg followed by two weeks montelukast 10mg.

    Reporting group title
    Low FeNO Group
    Reporting group description
    		 Subjects in this group received four weeks montelukast 10mg.

    Serious adverse events
    		 First arm High FeNO Second arm High FeNO Low FeNO Group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 15 (0.00%)
    0 / 14 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 First arm High FeNO Second arm High FeNO Low FeNO Group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    8 / 15 (53.33%)
    1 / 14 (7.14%)
    8 / 20 (40.00%)
    General disorders and administration site conditions
    Headache
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    0
    2
    Dizziness
         subjects affected / exposed
    0 / 15 (0.00%)
    1 / 14 (7.14%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    1
    Respiratory, thoracic and mediastinal disorders
    Respiratory tract infection
         subjects affected / exposed
    4 / 15 (26.67%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    4
    0
    1
    Cough
         subjects affected / exposed
    1 / 15 (6.67%)
    0 / 14 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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 results shown a significant reduction in cough frequency in the low FeNO group. To confirm effectiveness of montelukast in cough patients without presence of eosinophilic biomarkers there is a need for a large placebo controlled study.
    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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