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    Clinical Trial Results:
    Effects of ultra-long acting bronchodilator therapy assessed by impulse oscillometry in smoking asthmatics taking inhaled corticosteroids

    Summary
    EudraCT number
    		 2014-005317-23
    Trial protocol
    		 GB  
    Global end of trial date
    22 May 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Nov 2020
    First version publication date
    25 Nov 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    2013RC06
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02682862
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Dundee - NHS Tayside
    Sponsor organisation address
    Residency Block, Level 3, Ninewells Hospital, George Pirie Way, Dundee, United Kingdom, DD1 9SY
    Public contact
    General Enquiries, Scottish Centre for Respiratory Research, 44 (0)1382 383902, scrr@dundee.ac.uk
    Scientific contact
    General Enquiries, Scottish Centre for Respiratory Research, 44 (0)1382 383902, scrr@dundee.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
    22 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 May 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    22 May 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the effects of olodaterol alone versus olodaterol plus tiotropium given once daily as add-on therapy to pre-existing inhaled corticosteroids using impulse oscillometry in smoking asthmatics
    Protection of trial subjects
    The study Sponsor carried out a study risk assessment before issuing approval. The study was approved by the East of Scotland Research Ethics Service (Ref: 15/ES/0032). Informed consent was obtained from all participants. Participants were checked against all inclusion and exclusion criteria and only participants deemed clinically stable were recruited into the study. A medically-qualified person confirmed that it was safe for the participant to receive the IMP. Participants were issued a peak flow and symptom diary to assess clinical stability throughout the study. Participants were also issued an out-of-hours contact card with the mobile number carried by medical staff for advice if they encountered any adverse effects. One week after the end of each treatment period, patients were contacted by phone as a safety follow-up.
    Background therapy
    		 After the screening visit, participants entered a 2-4 week run-in period when LABA or LAMA were stopped and participants’ ICS dose was rounded to equivalent reference ICS as HFA-BDP (Clenil Modulite pMDI). This dose of Clenil was then continued unchanged throughout the study.
    Evidence for comparator
    		 We used the LABA olodaterol (OLO), and the combination of olodaterol with the LAMA tiotropium (OLO/TIO) both delivered via the soft mist Respimat inhaler. The rationale for choosing the Respimat device was that it was possible to deliver the OLO and OLO/TIO via the same device.
    Actual start date of recruitment
    11 Jul 2016
    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: 29
    Worldwide total number of subjects
    29
    EEA total number of subjects
    29
    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)
    29
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subject recruitment began 11 July 2016 and the study completed on 22 May 2019. Of the 29 patients screened, 17 were randomised and 16 completed per protocol and were included in the final analysis.

    Pre-assignment
    Screening details
    		 Diagnosis of persistent asthma, current smokers, age 18-65 years, taking at least 400μg per day of ICS (as HFA-BDP Clenil equivalent dose). Patients with COPD or ACO were excluded. Patients who had an asthma exacerbation requiring systemic corticosteroids within 1 month of screening or requiring hospital admission within 3 months were excluded.

    Pre-assignment period milestones
    Number of subjects started
    		 29
    Number of subjects completed
    		 17

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Did Not Meet Inclusion Criteria: 9
    Reason: Number of subjects
    		 Worsening Asthma Symptoms During Run-In: 3
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable as this was an open-label study.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Olodaterol
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olodaterol
    Investigational medicinal product code
    Other name
    Striverdi Respimat
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants inhaled 2 puffs (2.5 micrograms/puff) of olodaterol once daily in the morning for 2 - 4 weeks.

    Arm title
    		 Olodaterol-Tiotropium
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Olodaterol-Tiotropium
    Investigational medicinal product code
    Other name
    Spiolto Respimat
    Pharmaceutical forms
    Inhalation solution
    Routes of administration
    Inhalation use
    Dosage and administration details
    Participants inhaled 2 puffs (2.5 micrograms/2.5micrograms per puff) of olodaterol-tiotropium once daily in the morning for 2 - 4 weeks.

    Number of subjects in period 1
    		Olodaterol Olodaterol-Tiotropium
    Started
    16
    17
    Completed
    16
    16
    Not completed
    0
    1
         Unable to comply with procedures of the protocol
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups [1]
    Reporting group title
    Overall Trial
    Reporting group description
    		 -

    Notes
    [1] - The number of subjects reported to be in the baseline period is not equal to the worldwide number of subjects enrolled in the trial. It is expected that these numbers will be the same.
    Justification: The worldwide number enrolled is the number of subjects screened into the study (29). The number of subjects in the baseline period is the number who were randomised into the study (17). Of these 17 subjects, 16 completed the study per protocol and were able to be analysed.
    Reporting group values
    		 Overall Trial Total
    Number of subjects
    		 17 17
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 17 17
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 42.41 ( 11.72 ) -
    Gender categorical
    Units: Subjects
        Female
    		 10 10
        Male
    		 7 7

    End points

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

    Reporting group title
    Olodaterol-Tiotropium
    Reporting group description
    		 -

    Subject analysis set title
    Completed Subjects
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Sixteen (16) current smokers with persistent asthma who completed both arms of the study per protocol.

    Primary: Total Airway Resistance (R5)

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    End point title
    		 Total Airway Resistance (R5)
    End point description
    End point type
    Primary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: kPa/l/s
    arithmetic mean (confidence interval 95%)
        Pooled baseline
    0.58 (0.51 to 0.65)
    0.58 (0.51 to 0.65)
        Peak first dose
    0.44 (0.37 to 0.51)
    0.43 (0.37 to 0.49)
        Peak last dose
    0.45 (0.37 to 0.52)
    0.44 (0.36 to 0.51)
        Final trough
    0.56 (0.47 to 0.66)
    0.51 (0.42 to 0.59)
    Statistical analysis title
    		 Repeated measures ANOVA
    Comparison groups
    Olodaterol v Olodaterol-Tiotropium
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 ANOVA
    Confidence interval

    Secondary: FEV1

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    End point title
    		 FEV1
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: litre(s)
    arithmetic mean (standard error)
        Pooled baseline
    2.40 ( 0.18 )
    2.40 ( 0.18 )
        Peak first dose
    2.64 ( 0.19 )
    2.65 ( 0.20 )
        Peak last dose
    2.70 ( 0.19 )
    2.74 ( 0.18 )
        Final trough
    2.53 ( 0.18 )
    2.60 ( 0.18 )
    No statistical analyses for this end point

    Secondary: FEF 25-75

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    End point title
    		 FEF 25-75
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: L/s
    arithmetic mean (standard error)
        Pooled baseline
    1.46 ( 0.17 )
    1.46 ( 0.17 )
        Peak first dose
    1.79 ( 0.20 )
    1.78 ( 0.23 )
        Peak last dose
    1.82 ( 0.21 )
    1.85 ( 0.21 )
        Final trough
    1.58 ( 0.18 )
    2.51 ( 0.17 )
    No statistical analyses for this end point

    Secondary: FVC

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    End point title
    		 FVC
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: litre(s)
    arithmetic mean (standard error)
        Pooled baseline
    3.49 ( 0.20 )
    3.49 ( 0.20 )
        Peak first dose
    3.65 ( 0.21 )
    3.63 ( 0.21 )
        Peak last dose
    3.71 ( 0.21 )
    3.77 ( 0.20 )
        Final trough
    3.59 ( 0.21 )
    3.69 ( 0.20 )
    No statistical analyses for this end point

    Secondary: R20

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    End point title
    		 R20
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: kPa/l/s
    arithmetic mean (standard error)
        Pooled baseline
    0.42 ( 0.02 )
    0.42 ( 0.02 )
        Peak first dose
    0.36 ( 0.02 )
    0.35 ( 0.02 )
        Peak last dose
    0.36 ( 0.02 )
    0.36 ( 0.02 )
        Final trough
    0.41 ( 0.02 )
    0.39 ( 0.02 )
    No statistical analyses for this end point

    Secondary: R5-R20

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    End point title
    		 R5-R20
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: kPa/l/s
    arithmetic mean (standard error)
        Pooled baseline
    0.17 ( 0.03 )
    0.17 ( 0.03 )
        Peak first dose
    0.09 ( 0.02 )
    0.08 ( 0.02 )
        Peak final dose
    0.09 ( 0.02 )
    0.08 ( 0.02 )
        Final trough
    0.15 ( 0.03 )
    0.12 ( 0.03 )
    No statistical analyses for this end point

    Secondary: AX

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    End point title
    		 AX
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: kPa/l
    arithmetic mean (standard error)
        Pooled baseline
    1.81 ( 0.32 )
    1.81 ( 0.32 )
        Peak first dose
    0.84 ( 0.23 )
    0.75 ( 0.21 )
        Peak last dose
    0.80 ( 0.23 )
    0.70 ( 0.22 )
        Final trough
    1.54 ( 0.40 )
    1.16 ( 0.34 )
    No statistical analyses for this end point

    Secondary: Fres

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    End point title
    		 Fres
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: hertz
    arithmetic mean (standard error)
        Pooled baseline
    19.75 ( 1.19 )
    19.75 ( 1.19 )
        Peak first dose
    14.66 ( 1.17 )
    14.48 ( 1.15 )
        Peak last dose
    14.09 ( 1.27 )
    13.69 ( 1.19 )
        Final trough
    18.40 ( 1.54 )
    16.11 ( 1.48 )
    No statistical analyses for this end point

    Secondary: X5

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    End point title
    		 X5
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: kPa/l/s
    arithmetic mean (standard error)
        Polled baseline
    -0.24 ( 0.03 )
    -0.24 ( 0.03 )
        Peak first dose
    -0.17 ( 0.03 )
    -0.15 ( 0.02 )
        Peak last dose
    -0.16 ( 0.02 )
    -0.15 ( 0.02 )
        Final trough
    -0.21 ( 0.03 )
    -0.19 ( 0.03 )
    No statistical analyses for this end point

    Secondary: Symptoms AM

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    End point title
    		 Symptoms AM
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: units
    arithmetic mean (standard error)
        Pooled baseline
    0.71 ( 0.12 )
    0.63 ( 0.10 )
        End of treatment
    0.51 ( 0.14 )
    0.39 ( 0.10 )
    No statistical analyses for this end point

    Secondary: Symptoms PM

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    End point title
    		 Symptoms PM
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: units
    arithmetic mean (standard error)
        Pooled baseline
    0.63 ( 0.10 )
    0.63 ( 0.10 )
        End of treatment
    0.31 ( 0.12 )
    0.27 ( 0.08 )
    No statistical analyses for this end point

    Secondary: Reliever AM

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    End point title
    		 Reliever AM
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: puffs
    arithmetic mean (standard error)
        Pooled baseline
    1.05 ( 0.20 )
    10.5 ( 0.20 )
        End of treatment
    0.55 ( 0.17 )
    0.45 ( 0.15 )
    No statistical analyses for this end point

    Secondary: Reliever PM

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    End point title
    		 Reliever PM
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: puffs
    arithmetic mean (standard error)
        Pooled baseline
    0.92 ( 0.20 )
    0.91 ( 0.20 )
        End of treatment
    0.55 ( 0.15 )
    0.33 ( 0.09 )
    No statistical analyses for this end point

    Secondary: PEF AM

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    End point title
    		 PEF AM
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: L/min
    arithmetic mean (standard error)
        Pooled baseline
    369 ( 26 )
    369 ( 26 )
        End of treatment
    408 ( 34 )
    420 ( 31 )
    No statistical analyses for this end point

    Secondary: PEF PM

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    End point title
    		 PEF PM
    End point description
    End point type
    Secondary
    End point timeframe
    2-4 weeks
    End point values
    		 Olodaterol Olodaterol-Tiotropium
    Number of subjects analysed
    16
    16
    Units: L/min
    arithmetic mean (standard error)
        Pooled baseline
    388 ( 31 )
    388 ( 31 )
        End of treatment
    408 ( 34 )
    420 ( 31 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse events were recorded from the time a participant consented to join the study until the last study visit.
    Adverse event reporting additional description
    Participants received training on how to record adverse events on trial-specific diary cards. At each study visit, participants were asked about the occurrence of any adverse events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.1
    Reporting groups
    Reporting group title
    Received IMP
    Reporting group description
    		 -

    Serious adverse events
    		 Received IMP
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Irritable Bowel Syndrome
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Received IMP
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 17 (88.24%)
    Injury, poisoning and procedural complications
    Limb Injury
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    8
    Sciatica
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    3
    Migraine
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    3
    Dizziness
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Insomnia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    General disorders and administration site conditions
    Influenza-like illness
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Lethargy
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Immune system disorders
    Allergy to arthropod bite
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Gastrointestinal disorders
    Haemorrhoids
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Tongue Blistering
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Nasopharyngitis
         subjects affected / exposed
    5 / 17 (29.41%)
         occurrences all number
    6
    Oropharyngeal pain
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Cough
         subjects affected / exposed
    3 / 17 (17.65%)
         occurrences all number
    3
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back Pain
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Arthralgia
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Musculoskeletal stiffness
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Arthritis
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Infections and infestations
    Oral Candidiasis
         subjects affected / exposed
    2 / 17 (11.76%)
         occurrences all number
    2
    Abscess
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Genital infection
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 17 (5.88%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    15 Dec 2015
    REC Amendment - Amendment to notify REC of changes made during application to MHRA for initial study approval.
    02 Aug 2016
    REC & MHRA Amendment - Amendment to specify that Clenil Modulite is the steroid inhaler to be used as background medication during the study.
    03 Apr 2018
    REC Amendment - Amendment for use of additional sources for patient recruitment.

    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.
    None reported
    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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