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    Clinical Trial Results:
    A pilot study into health pre and post treatment with intravenous Aminophylline and Hydrocortisone in severe asthmatics

    Summary
    EudraCT number
    		 2014-000182-45
    Trial protocol
    		 GB  
    Global end of trial date
    26 Feb 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Oct 2020
    First version publication date
    03 Oct 2020
    Other versions
    Summary report(s)
    		 05.03.2015_End of Trial Declaration

    Trial information

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    Trial identification
    Sponsor protocol code
    2013AT001B
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Royal Brompton and Harefield NHS Foundation Trust, Royal Brompton Hospital
    Sponsor organisation address
    Research Office, Sydney Street, London , United Kingdom, SW3 6NP
    Public contact
    Ira Jakupovic, Royal Brompton and Harefield NHS Foundation Trust, +44 02073518109, i.jakupovic@rbht.nhs.uk
    Scientific contact
    Dr Andrew Menzies-Gow, Royal Brompton and Harefield NHS Foundation Trust, +44 02073518109, i.jakupovic@rbht.nhs.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
    26 Feb 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Feb 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Is there a significant improvement lung function in severe asthmatic patients after receiving a course of IV Aminophylline and IV Hydrocortisone?
    Protection of trial subjects
    The IMPs are drugs routinely given in practice. The dose or length of treatment will not be altered for the purposes of this study. There are risks associated with the use IV Aminophylline. These include toxicity, hypersensitivity, headache, confusion cardiac disturbances such as arrhythmias and palpitations, gastrointestinal disturbances, rash, and visual disturbances. There are also some risks associated with the use of IV Hydrocortisone. IV Hydrocortisone is usually given on a short-term basis, so it is unlikely that side-effects will occur; however, the patient will be monitored by the clinical team for possible risks, such as, hypersensitivity, gastrointestinal disturbance, alterations in blood chemistry and electrolytes, altered anti-inflammatory and immunosuppressive effects. The patient will be monitored by the clinical team in a ward area when receiving these drugs. The IMPs are not being given to the patient for the purposes of research. Therefore the risks and side effects associated with these medicines will be monitored by the clinical team and acted on accordingly and in adherence with the study protocol.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Mar 2014
    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: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    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)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients have been recruited in line with the study protocol, from RBHT astham clinics.

    Pre-assignment
    Screening details
    		 4/4 patients screened, completed the study. Screening was undertaken in line with the study eligibility criteria.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Amynophillene/Hydrocortisone Arm
    Arm description
    		 The SARAH study was designe to examine two well-known RBH prescribed therapies in combination for the treatment of asthma.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Amynophylline hydrage 25mg/ml and Hydrocortisone sodium succinate for injection 100mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    Patients are admitted for approximately 7 to 10 days for the treatment regimen. This is guided by the patient as an individual and by their symptoms. The dose of IV Hydrocortisone is guided by the dose of Prednisolone the patient is already taking, at 100mg twice a day (equivalent to 50mg Prednisolone) or 100mg three times a day (equivalent to 75mg Prednisolone). The rate of Aminophylline is initially 0.5mg/kg/hour via continuous infusion and the dose is adjusted on a daily basis according to serum theophylline levels.

    Number of subjects in period 1
    		Amynophillene/Hydrocortisone Arm
    Started
    4
    Completed
    4

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Amynophillene/Hydrocortisone Arm
    Reporting group description
    		 The SARAH study was designe to examine two well-known RBH prescribed therapies in combination for the treatment of asthma.

    Subject analysis set title
    Overal trial
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    insufficient number of patient recruited to conduct analysis

    Primary: FEV1

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    End point title
    		 FEV1 [1]
    End point description
    A mean of difference in FEV1 from baseline to a post treatment measure will be performed. A change in the FEV1 will be estimated using a paired t-test. There is no correction for multiple comparisons as the aim is not to assess efficacy. There is no predefined subgroup analysis.
    End point type
    Primary
    End point timeframe
    Baseline to completion
    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: It has not been possible to analyse data due to early termination, as outlined in the attached document, Annex 3.
    End point values
    		 Amynophillene/Hydrocortisone Arm
    Number of subjects analysed
    4 [2]
    Units: l/sec
    0
    Notes
    [2] - insufficient number of pateints to conduct analysis
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Duration of th study
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Gastrointestinal
    Reporting group description
    		 -

    Serious adverse events
    		 Gastrointestinal
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0.05%
    Non-serious adverse events
    		 Gastrointestinal
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: This treatment is standard of care and we have noted that one patient experienced nausea as noted in the results section.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Dec 2014
    Changes made to the study prtocol, in relation to in relation to reporting of a serious breach, to ensure implementation of appropriate CAPAs.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    10 Sep 2014
    Serious Breach GCP-14-068 reported by the Sponsor in relation to conduct of study procedure. It was noted that the breach had no impact on the safety of study patients or the integrity of the study data. It was felt that accumulation of issues required regulatory reporting.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    This study was initially set up as an educational project. Unfortunatley, a study left employment prior to completion of the study. Due to early termination of the study, no meaningful data has been generated to allow analysis of results.
    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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