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    Clinical Trial Results:
    Ensayo clínico piloto, aleatorizado, controlado con placebo, paralelo, para evaluar la eficacia y seguridad de la tobramicina inhalada, en el paciente afecto de bronquiectasias, sin fibrosis quística e infección bronquial intermitente por Pseudomonas aeruginosa.

    Summary
    EudraCT number
    		 2005-005820-15
    Trial protocol
    		 ES  
    Global end of trial date
    31 Dec 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Nov 2021
    First version publication date
    13 Nov 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    ORRI-4
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    VHIR
    Sponsor organisation address
    Passeig Vall Hebron 119-129, Barcelona, Spain, 08035
    Public contact
    Joaquin Lopez-Soriano, VHIR, joaquin.lopez.soriano@vhir.org
    Scientific contact
    Ramon Orriols, VHIR, raorriols.girona.ics@gencat.cat
    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
    31 Dec 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Determinar si ell uso de tobramicina inhalada en los sujetos afectos de bronquiectasias e infección inicial o intermitente por Pseudomonas aeruginosa evita o retrasa la aparición de un nuevo cultivo positivo a Pseudomonas aeruginosa y aumenta el tiempo libre de exacerbaciones secundarias a Pseudomonas aeruginosa. To evaluate the efficacy of 3 months of nebulised tobramycin after a short course of intravenous antibiotics in the eradication of P. aeruginosa and its clinical consequences in nonCF bronchiectasis following initial P. aeruginosa infection.
    Protection of trial subjects
    During the 3 first months, all patients were controlled monthly and 5, 7, 9, 12 and 15 months thereafter. The number of exacerbations, number of hospital admissions and days of hospitalisation were registered. Supplementary use of oral antibiotics was allowed on the development of an exacerbation, defined as more frequent coughing, greater dyspnoea and an increase in sputum volume and purulence
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2006
    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
    Spain: 35
    Worldwide total number of subjects
    35
    EEA total number of subjects
    35
    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)
    0
    From 65 to 84 years
    35
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 35
    Number of subjects completed
    		 35

    Period 1
    Period 1 title
    Tobramycin (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Tobramycin
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Tobramycin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    300 mg twice daily for 3 months, nebulized solution for inhalatiom

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Saline 0.9%
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Twice daily during 3 motnhs, volumes equivalent to experimental group

    Number of subjects in period 1
    		Tobramycin Placebo
    Started
    16
    19
    Completed
    11
    17
    Not completed
    5
    2
         Physician decision
    5
    -
         Lost to follow-up
    -
    2

    Baseline characteristics

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Reporting group values
    		 Tobramycin Placebo Total
    Number of subjects
    		 16 19 35
    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
        median (standard deviation)
    		 69.4 ( 2.1 ) 70.11 ( 1.9 ) -
    Gender categorical
    Units: Subjects
        Female
    		 6 10 16
        Male
    		 10 9 19

    End points

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    End points reporting groups
    Reporting group title
    Tobramycin
    Reporting group description
    		 -

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Primary: Ps aeruginosa in sputum

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    End point title
    		 Ps aeruginosa in sputum
    End point description
    End point type
    Primary
    End point timeframe
    End of study (15 months)
    End point values
    		 Tobramycin Placebo
    Number of subjects analysed
    11
    17
    Units: percent
        number (not applicable)
    54.5
    29.4
    Statistical analysis title
    		 P aeruginosa in sputum
    Comparison groups
    Tobramycin v Placebo
    Number of subjects included in analysis
    28
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.048
    Method
    		 Fisher exact
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    15 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Total adverse events
    Reporting group description
    		 -

    Serious adverse events
    		 Total adverse events
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 35 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Total adverse events
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 35 (14.29%)
    Respiratory, thoracic and mediastinal disorders
    Bronchospasm
         subjects affected / exposed
    5 / 35 (14.29%)
         occurrences all number
    5

    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.
    Nebulised tobramycin therapy had to be discontinued due to bronchospasm in 5 patients, suggesting that the risk of this complication should be considered in patients with low FEV1 values. Larger number of patients and longer follow-up are desired

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/26340658
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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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