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    Clinical Trial Results:
    A randomised, open, controlled pilot study to investigate the efficacy and safety of Buparid/PARI SINUS versus Budes® Nasal Spray in the therapy of Chronic Rhinosinusitis (CRS) with polyposis nasi in adult patients

    Summary
    EudraCT number
    		 2013-002414-12
    Trial protocol
    		 DE  
    Global end of trial date
    21 Jun 2021

    Results information
    Results version number
    		 v2(current)
    This version publication date
    11 Sep 2021
    First version publication date
    30 Jul 2021
    Other versions
    		 v1
    Version creation reason
    • Correction of full data set
    Correction of data on 26. Aug 2021
    Summary report(s)
    		 Study Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    12082.101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    PARI Pharma GmbH
    Sponsor organisation address
    Lochhamer Schlag 21, Gräfelfing, Germany, 82166
    Public contact
    Clinical Development Department, PARI Pharma GmbH, +49 8974284676, friedrich.gruber@pari.com
    Scientific contact
    Clinical Development Department, PARI Pharma GmbH, +49 8974284676, friedrich.gruber@pari.com
    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
    03 Feb 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Jun 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The objective of this study is to create data for the selection of a clinically relevant primary endpoint to assess the efficacy and safety of Buparid/PARI SINUS as compared to Budes Nasal Spray in the therapy of chronic rhinosinusitis (CRS) with polyposis nasi in adult patients. Ideally, the selected parameter should allow a correlation between an objective methodology and the clinical outcome of the study patients.
    Protection of trial subjects
    Special caution is necessary in patients with active or quiescent pulmonary tuberculosis and in patients with fungal or viral infections in the airways. During transfer from oral therapy to Buparid, a generally lower systemic corticosteroid action will be experienced, which may result in the appearance of allergic or arthritic symptoms such as rhinitis, eczema and muscle and joint pain. Specific treatment should be initiated for these conditions. A general insufficient glucocorticosteroid effect should be suspected if, in rare cases, symptoms such as tiredness, headache, nausea and vomiting should occur. In these cases a temporary increase in the dose of oral glucocorticosteroids is sometimes necessary. Patients, who have required high dose emergency corticosteroid therapy or prolonged treatment at the highest recommended dose of inhaled corticosteroids, may also be at risk of impaired adrenal function. These patients may exhibit signs and symptoms of adrenal insufficiency when exposed to severe stress. Additional systemic corticosteroid treatment should be considered during periods of stress or elective surgery. Systemic effects may occur with any inhaled corticosteroids, particularly at high doses prescribed for long periods. These effects are much less likely to occur with inhalation treatment than with oral corticosteroids. Possible systemic effects include Cushing's syndrome, Cushingoid features, adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and more rarely, a range of psychological or behavioural effects including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggression (particularly in children). Oral candidiasis may occur during the therapy with inhaled corticosteroids. This infection may require treatment with appropriate antifungal therapy and in some patients discontinuation of treatment may be necessary.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    28 Aug 2013
    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
    Germany: 18
    Worldwide total number of subjects
    18
    EEA total number of subjects
    18
    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)
    18
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrolment period: 18 months; 3 clinical centres in Germany participating in the trial

    Pre-assignment
    Screening details
    		 Diagnosis and main criteria for inclusion: Patient with confirmed diagnosis of CRS, i.e. inflammation of nasal mucosa and paranasal sinus, with polyposis nasi grade I-III. Diagnosis is based on history of symptoms (nasal obstruction, running nose, postnasal drip, facial pain and hyposmia with a duration of > 3 months and on MRT-imaging)

    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
    n.a.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API:
    Arm description
    		 Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: Budesonide
    Arm type
    		 Experimental

    Investigational medicinal product name
    Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: Budesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nebuliser solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    In patients allocated to receive Buparid, the drug was administered by a once daily inhalation (in the evening) using the PARI SINUS nebuliser. At every study visit, one inhalation cycle was monitored by the clinical trial centre personnel.

    Arm title
    		 Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide
    Arm description
    		 Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Intranasal use
    Dosage and administration details
    In patients allocated to receive Budes Nasal Spray, the drug was administered with 2 pumps per nostril twice daily (in the morning and the evening).

    Number of subjects in period 1 [1]
    		Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide
    Started
    8
    6
    Completed
    8
    6
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 4 patients enrolled but not randomised

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API:
    Reporting group description
    		 Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: Budesonide

    Reporting group title
    Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide
    Reporting group description
    		 Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide

    Reporting group values
    		 Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide Total
    Number of subjects
    		 8 6 14
    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
    Age (mean +/- SD)
    Units: years
        arithmetic mean (standard deviation)
    		 49.0 ± 11.2 59.5 ± 12.2 -
    Gender categorical
    Units: Subjects
        Female
    		 3 3 6
        Male
    		 5 3 8

    End points

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    End points reporting groups
    Reporting group title
    Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API:
    Reporting group description
    		 Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: Budesonide

    Reporting group title
    Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide
    Reporting group description
    		 Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide

    Primary: Nasal obstruction

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    End point title
    		 Nasal obstruction
    End point description
    End point type
    Primary
    End point timeframe
    visits 1 to 4
    End point values
    		 Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide
    Number of subjects analysed
    8
    6
    Units: Change from baseline
        median (confidence interval 95%)
    755 (644 to 867)
    646 (526 to 765)
    Statistical analysis title
    		 Rhinomanometry
    Comparison groups
    Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: v Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 > 0.95
    Method
    		 MMRM
    Confidence interval

    Primary: Health-specific quality of life

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    End point title
    		 Health-specific quality of life
    End point description
    End point type
    Primary
    End point timeframe
    Visits 1 to 6
    End point values
    		 Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide
    Number of subjects analysed
    8
    6
    Units: change to baseline
        arithmetic mean (confidence interval 95%)
    23.6 (19.7 to 27.6)
    14.4 (9.8 to 18.9)
    Statistical analysis title
    		 SNOT-22
    Comparison groups
    Buparid 1 mg/2 ml nebuliser solution (PARI Pharma GmbH); API: v Budes® Nasal Spray 50 µg/pump (Hexal AG); API: Budesonide
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 MMRM
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    from FPI until LPO
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17
    Reporting groups
    Reporting group title
    Arm 1 Buparid SINUS
    Reporting group description
    		 -

    Reporting group title
    Arm 2 Budes Nasal Spray
    Reporting group description
    		 -

    Serious adverse events
    		 Arm 1 Buparid SINUS Arm 2 Budes Nasal Spray
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 8 (0.00%)
    0 / 6 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Arm 1 Buparid SINUS Arm 2 Budes Nasal Spray
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 8 (62.50%)
    4 / 6 (66.67%)
    Nervous system disorders
    Parosmia
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Headache
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Sputum Increased
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Nasal Dryness
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Cough
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Epistaxis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0
    Oropharyngeal pain
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Skin and subcutaneous tissue disorders
    Sensitive skin
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    0
    1
    Infections and infestations
    Otitis media
         subjects affected / exposed
    0 / 8 (0.00%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 8 (12.50%)
    1 / 6 (16.67%)
         occurrences all number
    1
    1
    Sinusitis
         subjects affected / exposed
    1 / 8 (12.50%)
    0 / 6 (0.00%)
         occurrences all number
    1
    0

    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.
    None reported
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