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    Clinical Trial Results:
    A Phase II/III, Double-Blind, Randomized, Placebo-Controlled, Multicenter, International Study Evaluating the Safety and Efficacy of Inhaled, Human, Alpha-1 Antitrypsin (AAT) in Alpha-1 Antitrypsin Deficient Patients with Emphysema

    Summary
    EudraCT number
    2008-005326-36
    Trial protocol
    GB   NL   SE   DK   DE   IE  
    Global end of trial date
    11 Dec 2013

    Results information
    Results version number
    v1(current)
    This version publication date
    05 Sep 2019
    First version publication date
    05 Sep 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    Kamada-AAT(inhaled)-007
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01217671
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Kamada Ltd
    Sponsor organisation address
    2 Holtzman Street, Weizmann Science Park, Rehovot, Israel, 7670402
    Public contact
    Sponsor, Kamada Limited, 00972 89406472,
    Scientific contact
    Sponsor, Kamada Limited, 00972 89406472,
    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
    26 Feb 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    10 Dec 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To explore rate and severity of exacerbations in AAT deficient patients when treated with inhaled AAT or placebo during a 50-week double-blind treatment period. The objective will be evaluated by the primary endpoint of the time from randomization to the first exacerbation with a severity of moderate or severe.
    Protection of trial subjects
    Patients were trained in the operation and cleaning of the eFlow® inhalation device (PARI Pharma GmbH, Germany). Instructions included a demonstration of the nebuliser and training in the use of an electronic diary (eDiary, the LogPad (PHT Corporation, Switzerland)). This diary recorded the daily condition of the patient so that the physicians could be alerted if there was a change in the clinical condition of the patient and respond accordingly.
    Background therapy
    Study patients were allowed free use of concomitant medications for the treatment of the underlying disease, including antibiotics, steroids (inhaled and systemic), as well as any additional therapy approved by the principal investigator of the study site
    Evidence for comparator
    -
    Actual start date of recruitment
    18 Mar 2010
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    Safety
    Long term follow-up duration
    1 Years
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 36
    Country: Number of subjects enrolled
    Sweden: 22
    Country: Number of subjects enrolled
    United Kingdom: 56
    Country: Number of subjects enrolled
    Denmark: 13
    Country: Number of subjects enrolled
    Germany: 14
    Country: Number of subjects enrolled
    Ireland: 15
    Country: Number of subjects enrolled
    Canada: 12
    Worldwide total number of subjects
    168
    EEA total number of subjects
    156
    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)
    135
    From 65 to 84 years
    33
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    Men and women over the age of 18 with a diagnosis of emphysema confirmed by computed tomography (CT) scan and a record of inherited severe AATD (ZZ or other rare genotypes with a serum AAT level below 11 µM). Patients (168) were recruited between 18/March/2010 and 17/December/2012 in 12 sites in 7 countries. Randomization was 1:1 placebo or AAT.

    Pre-assignment
    Screening details
    The inclusion criteria included FEV1 percent predicted post-bronchodilator < 80%, and a history of two or more moderate or severe exacerbations requiring a change in treatment (antibiotics, systemic steroids, hospitalization) over the past 18 months, with at least one episode within the 12 months prior to screening.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Monitor, Data analyst, Carer, Assessor
    Blinding implementation details
    Eligible patients were randomized 1:1 to receive study drug or placebo by an IVRS system. Allocation of the study drug during the study was also regulated by the IVRS. Site staff telephoned IVRS prior to dispensing the study drug and were notified of the AAT kit labels to be dispensed.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Kamada-AAT for Inhalation
    Arm description
    Study Drug was administered by eFlow® nebulizer twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. Kamada-AAT for Inhalation was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.
    Arm type
    Experimental

    Investigational medicinal product name
    Kamada AAT for Inhalation
    Investigational medicinal product code
    EMEA/H/C/003934
    Other name
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment with study drug began at the baseline/randomization visit and continued for a period of 50 weeks. During this period, either Kamada-AAT for Inhalation 80 mg or placebo was administered by eFlow® nebulizer twice daily, each session lasting for approximately 10 to 15 minutes (i.e., a total daily dose of 160 mg of AAT or an equivalent volume of placebo). If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of study drug.

    Arm title
    Placebo for Inhalation
    Arm description
    Placebo was administered by eFlow® twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. The placebo was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.
    Arm type
    Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    EMEA/H/C/003934
    Other name
    Kamada-AAT for Inhalation
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Treatment with study drug began at the baseline/randomization visit and continued for a period of 50 weeks. During this period, either Kamada-AAT for Inhalation 80 mg or placebo was administered by eFlow® twice daily, each session lasting for approximately 10 to 15 minutes (i.e., a total daily dose of 160 mg of AAT or an equivalent volume of placebo). If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the AAT.

    Number of subjects in period 1
    Kamada-AAT for Inhalation Placebo for Inhalation
    Started
    85
    83
    Completed
    51
    69
    Not completed
    34
    14
         Adverse event, serious fatal
    1
    -
         Possible side effects
    1
    -
         No confirmed AATD
    -
    1
         Consent withdrawn by subject
    12
    4
         Health and social circumstances
    1
    -
         Adverse event, non-fatal
    15
    6
         Patient moved to lung transplantation list
    1
    -
         Family Circumstances
    -
    1
         Lost to follow-up
    2
    2
         Failure to attend visits
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Kamada-AAT for Inhalation
    Reporting group description
    Study Drug was administered by eFlow® nebulizer twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. Kamada-AAT for Inhalation was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.

    Reporting group title
    Placebo for Inhalation
    Reporting group description
    Placebo was administered by eFlow® twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. The placebo was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.

    Reporting group values
    Kamada-AAT for Inhalation Placebo for Inhalation Total
    Number of subjects
    85 83 168
    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)
    67 68 135
        From 65-84 years
    18 15 33
        85 years and over
    0 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    57 (48 to 63) 53 (46.5 to 61.5) -
    Gender categorical
    Units: Subjects
        Female
    34 34 68
        Male
    51 49 100

    End points

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    End points reporting groups
    Reporting group title
    Kamada-AAT for Inhalation
    Reporting group description
    Study Drug was administered by eFlow® nebulizer twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. Kamada-AAT for Inhalation was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.

    Reporting group title
    Placebo for Inhalation
    Reporting group description
    Placebo was administered by eFlow® twice daily, each session lasting for approximately 10 to 15 minutes. If the subject was required to inhale a bronchodilator, this was administered prior to inhalation of the placebo. The placebo was supplied in sterile, single-use glass vials containing 4 mL of a ready-to-use solution.

    Primary: The time from randomization to the first event-based exacerbation with a severity of moderate or severe

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    End point title
    The time from randomization to the first event-based exacerbation with a severity of moderate or severe
    End point description
    A moderate event-based exacerbation was defined as a course of treatment with antibiotics and/or systemic corticosteroids and severe exacerbation as an episode requiring hospitalisation. For patients taking routine antibiotics, any increase in the current dose of antibiotics or change of type of antibiotics was deemed to indicate a moderate exacerbation. The time to first moderate/severe and mild/moderate/severe exacerbation was derived from the subject’s eDiary and updated after a blind review by two experts in the field. They reconciled the eDiary data with the concomitant medications and reports of treatment emergent adverse events in order to determine the start date and severity of the symptom-based exacerbation.
    End point type
    Primary
    End point timeframe
    50 weeks
    End point values
    Kamada-AAT for Inhalation Placebo for Inhalation
    Number of subjects analysed
    63
    60
    Units: Days
    112
    140
    Statistical analysis title
    Time to first serious or moderate exacerbation
    Statistical analysis description
    Median days to first serious or moderate exacerbation
    Comparison groups
    Kamada-AAT for Inhalation v Placebo for Inhalation
    Number of subjects included in analysis
    123
    Analysis specification
    Pre-specified
    Analysis type
    superiority [1]
    P-value
    = 0.0952 [2]
    Method
    Logrank
    Confidence interval
    Notes
    [1] - Analysis of ITT population
    [2] - p Value from Log Rank comparison between treatments adjusted for country

    Post-hoc: Improvement in lung function measures

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    End point title
    Improvement in lung function measures
    End point description
    Overall change of FEV1 from baseline to 50 weeks
    End point type
    Post-hoc
    End point timeframe
    Change from baseline to 50 weeks
    End point values
    Kamada-AAT for Inhalation Placebo for Inhalation
    Number of subjects analysed
    85 [3]
    83 [4]
    Units: ml
        number (not applicable)
    18.6
    -29.4
    Attachments
    Untitled (Filename: Overall Change in FEV1.pdf)
    Notes
    [3] - The parameter is calculated as the overall change so all the patients contribute to the final value
    [4] - The parameter is calculated as the overall change so all the patients contribute to the final value
    Statistical analysis title
    Change in FEV1
    Statistical analysis description
    Overall change of FEV1 from baseline to 50 weeks
    Comparison groups
    Kamada-AAT for Inhalation v Placebo for Inhalation
    Number of subjects included in analysis
    168
    Analysis specification
    Post-hoc
    Analysis type
    superiority [5]
    P-value
    = 0.0124 [6]
    Method
    Mixed models analysis
    Parameter type
    LS Mean overall change from baseline
    Point estimate
    48
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    13.5
         upper limit
    82.43
    Variability estimate
    Standard error of the mean
    Notes
    [5] - The results along the DB period were analyzed by Mixed Model For Repeated Measures (MMRM) comparing the least squares means for the changes from baseline at week 50 and the overall effect in the two cohorts
    [6] - The same pattern of statistical significant favourable response in the AAT-treated patients group was observed, regardless of the imputation method used to deal with missing data.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    54 weeks
    Adverse event reporting additional description
    50 weeks of treatment and 4 weeks follow-up. Events were reported by the patient
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    12.1
    Reporting groups
    Reporting group title
    Safety Population AAT
    Reporting group description
    All patients who were exposed to study drug

    Reporting group title
    Safety Population Placebo
    Reporting group description
    All patients who were not exposed to study drug

    Serious adverse events
    Safety Population AAT Safety Population Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    30 / 87 (34.48%)
    15 / 81 (18.52%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    1
    0
    Investigations
    Electrocardiogram T wave inversion
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Metastases to lung
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine leiomyosarcoma
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Multiple fractures
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Muscle strain
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Arterial haemorrhage
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Facial palsy
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Idiopathic thrombocytopenia purpura
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    4 / 87 (4.60%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Dyspnoea
         subjects affected / exposed
    7 / 87 (8.05%)
    6 / 81 (7.41%)
         occurrences causally related to treatment / all
    1 / 7
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Emphysema
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Haemoptysis
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypoxia
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Paranasal cyst
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pleuritic pain
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Bronchiectasis
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diverticulitis
         subjects affected / exposed
    2 / 87 (2.30%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    4 / 87 (4.60%)
    2 / 81 (2.47%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung infection
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis
         subjects affected / exposed
    0 / 87 (0.00%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    4 / 87 (4.60%)
    3 / 81 (3.70%)
         occurrences causally related to treatment / all
    1 / 4
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory tract infection
         subjects affected / exposed
    1 / 87 (1.15%)
    1 / 81 (1.23%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Sputum purulent
         subjects affected / exposed
    1 / 87 (1.15%)
    0 / 81 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Safety Population AAT Safety Population Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    86 / 87 (98.85%)
    78 / 81 (96.30%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    9 / 87 (10.34%)
    10 / 81 (12.35%)
         occurrences all number
    12
    13
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    9 / 87 (10.34%)
    9 / 81 (11.11%)
         occurrences all number
    16
    10
    Influenza like illness
         subjects affected / exposed
    8 / 87 (9.20%)
    7 / 81 (8.64%)
         occurrences all number
    21
    16
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    8 / 87 (9.20%)
    10 / 81 (12.35%)
         occurrences all number
    10
    12
    Dry mouth
         subjects affected / exposed
    7 / 87 (8.05%)
    4 / 81 (4.94%)
         occurrences all number
    7
    5
    Nausea
         subjects affected / exposed
    10 / 87 (11.49%)
    5 / 81 (6.17%)
         occurrences all number
    14
    6
    Vomiting
         subjects affected / exposed
    4 / 87 (4.60%)
    5 / 81 (6.17%)
         occurrences all number
    4
    5
    Respiratory, thoracic and mediastinal disorders
    Chronic obstructive pulmonary disease
         subjects affected / exposed
    41 / 87 (47.13%)
    38 / 81 (46.91%)
         occurrences all number
    92
    84
    Cough
         subjects affected / exposed
    17 / 87 (19.54%)
    16 / 81 (19.75%)
         occurrences all number
    24
    20
    Dysphonia
         subjects affected / exposed
    5 / 87 (5.75%)
    7 / 81 (8.64%)
         occurrences all number
    5
    8
    Dyspnoea
         subjects affected / exposed
    37 / 87 (42.53%)
    33 / 81 (40.74%)
         occurrences all number
    70
    69
    Haemoptysis
         subjects affected / exposed
    5 / 87 (5.75%)
    2 / 81 (2.47%)
         occurrences all number
    7
    2
    Nasal congestion
         subjects affected / exposed
    1 / 87 (1.15%)
    5 / 81 (6.17%)
         occurrences all number
    1
    7
    Oropharyngeal pain
         subjects affected / exposed
    10 / 87 (11.49%)
    5 / 81 (6.17%)
         occurrences all number
    13
    7
    Productive cough
         subjects affected / exposed
    14 / 87 (16.09%)
    8 / 81 (9.88%)
         occurrences all number
    21
    13
    Sputum discoloured
         subjects affected / exposed
    9 / 87 (10.34%)
    2 / 81 (2.47%)
         occurrences all number
    11
    2
    Sputum increased
         subjects affected / exposed
    7 / 87 (8.05%)
    4 / 81 (4.94%)
         occurrences all number
    9
    8
    Wheezing
         subjects affected / exposed
    2 / 87 (2.30%)
    6 / 81 (7.41%)
         occurrences all number
    2
    6
    Musculoskeletal and connective tissue disorders
    Musculoskeletal chest pain
         subjects affected / exposed
    5 / 87 (5.75%)
    6 / 81 (7.41%)
         occurrences all number
    8
    6
    Infections and infestations
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    7 / 87 (8.05%)
    3 / 81 (3.70%)
         occurrences all number
    13
    13
    Influenza
         subjects affected / exposed
    6 / 87 (6.90%)
    2 / 81 (2.47%)
         occurrences all number
    9
    5
    Lower respiratory tract infection
         subjects affected / exposed
    17 / 87 (19.54%)
    14 / 81 (17.28%)
         occurrences all number
    44
    29
    Nasopharyngitis
         subjects affected / exposed
    12 / 87 (13.79%)
    12 / 81 (14.81%)
         occurrences all number
    17
    14
    Oral candidiasis
         subjects affected / exposed
    7 / 87 (8.05%)
    1 / 81 (1.23%)
         occurrences all number
    9
    1
    Rhinitis
         subjects affected / exposed
    5 / 87 (5.75%)
    3 / 81 (3.70%)
         occurrences all number
    7
    4
    Sinusitis
         subjects affected / exposed
    8 / 87 (9.20%)
    2 / 81 (2.47%)
         occurrences all number
    8
    3
    Upper respiratory tract infection
         subjects affected / exposed
    8 / 87 (9.20%)
    9 / 81 (11.11%)
         occurrences all number
    12
    13

    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.
    While the study did not meet the primary endpoint of time to first moderate or severe exacerbation, post hoc analysis showed that treatment with Kamada- AAT for Inhalation improved pulmonary function
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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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