Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44306   clinical trials with a EudraCT protocol, of which   7355   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Nasal Airway Obstruction Study (NAIROS)

    Summary
    EudraCT number
    		 2017-000893-12
    Trial protocol
    		 GB  
    Global end of trial date
    17 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Dec 2021
    First version publication date
    17 Dec 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    8302
    Additional study identifiers
    ISRCTN number
    		 ISRCTN16168569
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 ISRCTN: 16168569, REC Reference: 17/NE/0239
    Sponsors
    Sponsor organisation name
    The Newcastle upon Tyne Hospitals NHS Foundation Trust
    Sponsor organisation address
    Freeman Hospital, Freeman Road, Newcastle upon Tyne, United Kingdom, NE7 7DN
    Public contact
    Mr Sean Carrie, The Newcastle upon Tyne Hospitals NHS Foundation Trust, 44 01912137635, sean.carrie@nhs.net
    Scientific contact
    Mr Sean Carrie, The Newcastle upon Tyne Hospitals NHS Foundation Trust, 44 01912137635, sean.carrie@nhs.net
    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
    29 Jan 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    17 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To establish, and inform guidance for, the best management strategy for participants with nasal obstruction associated with a deviated septum via a randomised controlled trial: a. To compare clinical and cost effectiveness over 6 months in adults with nasal septal deviation between nasal septoplasty +/- contralateral turbinate reduction and medical management. b. To apply NAIROS level I evidence to inform NHS guidance. NAIROS is a pragmatic trial, and as such the analysis data provided in this report is from the Intention-To-Treat (ITT) population.
    Protection of trial subjects
    An Independent Data Monitoring Committee (IDMC) was convened at least annually to undertake an independent review of data, including safety data. The IDMC reported to the Trial Steering Committee, who made recommendations to the Trial Management Group. No other specific action was required to protect trial subjects.
    Background therapy
    		 Prior to the clinical examination (nasal endoscopy), the use of topical local anaesthetic was left to investigator discretion. All participants received a topical decongestant (Xylometazoline Hydrochloride Nasal Spray) prior to administration of the Double Ordinal Airway Subjective Scale (DOASS).
    Evidence for comparator
    		 Mometasone furoate spray is licensed in dosage and form for use in patients with reduced nasal airway in the UK and is standard care for this indication.
    Actual start date of recruitment
    18 Jan 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 378
    Worldwide total number of subjects
    378
    EEA total number of subjects
    0
    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)
    358
    From 65 to 84 years
    20
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Adult participants, who had the capacity to give written informed consent, were recruited from patients referred to secondary care rhinology clinics at 17 sites across Scotland, England and Wales. Participants were recruited between 18 January 2018 and 05 December 2019.

    Pre-assignment
    Screening details
    		 Prior to randomisation, the participant's medical history was documented and a clinical examination of the nasal passages conducted to determine that all of the inclusion criteria and none of the exclusion criteria, were met.

    Period 1
    Period 1 title
    Randomisation
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Randomisation was administered centrally by the Newcastle Clinical Trials Unit (NCTU) secure web-based system on a 1:1 basis using permuted blocks of variable length, stratified by gender and three recognised NOSE-derived categories of baseline severity (30-50 = Moderate, 55-75 = Severe, 80-100 = Extreme). Assignment to either the surgical intervention (septoplasty) or medical management (mometasone furoate spray) was open label.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Septoplasty
    Arm description
    		 The surgical intervention under investigation was septoplasty, plus/minus unilateral turbinate reduction.
    Arm type
    		 surgical

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Medical Management
    Arm description
    		 Mometasone furoate spray, taken twice daily at 100 microgram (2 sprays in each nostril twice daily) for 6 weeks followed by 2 sprays in each nostril once daily or 1 spray in each nostril twice daily for the remainder of the 6 month intervention period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mometasone furoate spray suspension (50 micrograms/actuation)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    100mcg (2 sprays) into each nostril twice daily for 6 weeks followed by 100mcg (2 sprays into each nostril) once daily or 50mcg (1 spray) into each nostril twice daily for the remainder of the 6 month period.

    Number of subjects in period 1
    		Septoplasty Medical Management
    Started
    188
    190
    Completed
    188
    190
    Period 2
    Period 2 title
    Randomisation to 2 week assessment (MM)
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Septoplasty
    Arm description
    		 The surgical intervention under investigation was septoplasty, plus/minus unilateral turbinate reduction.
    Arm type
    		 surgical

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Medical Management
    Arm description
    		 Mometasone furoate spray, taken twice daily at 100micrograms (2 sprays in each nostril twice daily ) for 6 weeks followed by 2 sprays in each nostril once daily or 1 spray in each nostril twice daily for the remainder of the 6 month intervention period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mometasone furoate spray suspension (50 micrograms/actuation)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    100mcg (2 sprays) into each nostril twice daily for 6 weeks followed by 100mcg (2 sprays into each nostril) once daily or 50mcg (1 spray) into each nostril twice daily for the remainder of the 6 month period.

    Number of subjects in period 2
    		Septoplasty Medical Management
    Started
    188
    190
    Completed
    188
    185
    Not completed
    0
    5
         Consent withdrawn by subject
    -
    5
    Period 3
    Period 3 title
    2 week assessment to 6 month assessment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Septoplasty
    Arm description
    		 The surgical intervention under investigation was septoplasty, plus/minus unilateral turbinate reduction.
    Arm type
    		 surgical

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Medical Management
    Arm description
    		 Mometasone furoate spray, taken twice daily at 100micrograms (2 sprays in each nostril twice daily ) for 6 weeks followed by 2 sprays into each nostril once daily or 1 spray in each nostril twice daily for the remainder of the 6 month intervention period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mometasone furoate spray suspension (50 micrograms/actuation)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    100mcg (2 sprays) into each nostril twice daily for 6 weeks followed by 100mcg (2 sprays into each nostril) once daily or 50mcg (1 spray) into each nostril twice daily for the remainder of the 6 month period.

    Number of subjects in period 3
    		Septoplasty Medical Management
    Started
    188
    185
    Completed
    173
    175
    Not completed
    15
    10
         Consent withdrawn by subject
    15
    10
    Period 4
    Period 4 title
    6 month assessmen to 12 month assessment
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Septoplasty
    Arm description
    		 The surgical intervention under investigation was septoplasty, plus/minus unilateral turbinate reduction.
    Arm type
    		 surgical

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Medical Management
    Arm description
    		 Mometasone furoate spray, taken twice daily at 100micrograms (2 sprays in each nostril twice daily ) for 6 weeks followed by 2 sprays once daily into each nostril or 1 spray in each nostril twice daily for the remainder of the 6 month intervention period.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Mometasone furoate nasal spray suspension (50 micrograms/actuation)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray, suspension
    Routes of administration
    Nasal use
    Dosage and administration details
    100mcg (2 sprays) into each nostril twice daily for 6 weeks followed by 100mcg (2 sprays into each nostril) once daily or 50mcg (1 spray) into each nostril twice daily for the remainder of the 6 month period.

    Number of subjects in period 4
    		Septoplasty Medical Management
    Started
    173
    175
    Completed
    122
    132
    Not completed
    51
    43
         Consent withdrawn by subject
    10
    10
         Lost to follow-up
    41
    33

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Septoplasty
    Reporting group description
    		 The surgical intervention under investigation was septoplasty, plus/minus unilateral turbinate reduction.

    Reporting group title
    Medical Management
    Reporting group description
    		 Mometasone furoate spray, taken twice daily at 100 microgram (2 sprays in each nostril twice daily) for 6 weeks followed by 2 sprays in each nostril once daily or 1 spray in each nostril twice daily for the remainder of the 6 month intervention period.

    Reporting group values
    		 Septoplasty Medical Management Total
    Number of subjects
    		 188 190 378
    Age categorical
    Patients who have attended a rhinology clinic and consented to screening assessments
    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)
    		 175 183 358
        From 65-84 years
    		 13 7 20
        85 years and over
    		 0 0 0
    Gender categorical
    Units: Subjects
        Female
    		 62 63 125
        Male
    		 126 127 253
    Ethnic Group
    Units: Subjects
        White
    		 169 165 334
        Asian (Indian/Pakistani/Bangladeshi ancestry)
    		 13 14 27
        Other Asian
    		 1 2 3
        Other ethnic origin
    		 3 9 12
        Not Recorded
    		 2 0 2
    NOSE score category
    Randomisation stratification - NOSE score expressed as a category
    Units: Subjects
        moderate
    		 30 32 62
        severe
    		 89 89 178
        extreme
    		 69 69 138
        not recorded
    		 0 0 0

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Septoplasty
    Reporting group description
    		 The surgical intervention under investigation was septoplasty, plus/minus unilateral turbinate reduction.

    Reporting group title
    Medical Management
    Reporting group description
    		 Mometasone furoate spray, taken twice daily at 100 microgram (2 sprays in each nostril twice daily) for 6 weeks followed by 2 sprays in each nostril once daily or 1 spray in each nostril twice daily for the remainder of the 6 month intervention period.
    Reporting group title
    Septoplasty
    Reporting group description
    		 The surgical intervention under investigation was septoplasty, plus/minus unilateral turbinate reduction.

    Reporting group title
    Medical Management
    Reporting group description
    		 Mometasone furoate spray, taken twice daily at 100micrograms (2 sprays in each nostril twice daily ) for 6 weeks followed by 2 sprays in each nostril once daily or 1 spray in each nostril twice daily for the remainder of the 6 month intervention period.
    Reporting group title
    Septoplasty
    Reporting group description
    		 The surgical intervention under investigation was septoplasty, plus/minus unilateral turbinate reduction.

    Reporting group title
    Medical Management
    Reporting group description
    		 Mometasone furoate spray, taken twice daily at 100micrograms (2 sprays in each nostril twice daily ) for 6 weeks followed by 2 sprays into each nostril once daily or 1 spray in each nostril twice daily for the remainder of the 6 month intervention period.
    Reporting group title
    Septoplasty
    Reporting group description
    		 The surgical intervention under investigation was septoplasty, plus/minus unilateral turbinate reduction.

    Reporting group title
    Medical Management
    Reporting group description
    		 Mometasone furoate spray, taken twice daily at 100micrograms (2 sprays in each nostril twice daily ) for 6 weeks followed by 2 sprays once daily into each nostril or 1 spray in each nostril twice daily for the remainder of the 6 month intervention period.

    Primary: SNOT-22 score at 6 months

    		 Close Top of page
    End point title
    		 SNOT-22 score at 6 months
    End point description
    The 22-item Sinonasal outcome test (SNOT-22) is a validated patient reported questionnaire, used to assess general sinonasal symptoms. SNOT-22 consists of 22 questions that are answered on a scale from “0” (no problem) up to “5” (problem as bad as it can be). The total score is generated by adding all item values. The total can range from 0 (no problem) to 110 (problem as severe as it can be).
    End point type
    Primary
    End point timeframe
    SNOT-22 score at 6 months post-randomisation
    End point values
    		 Septoplasty Medical Management
    Number of subjects analysed
    152 [1]
    155 [2]
    Units: total score
        arithmetic mean (confidence interval 95%)
    19.9 (17.0 to 22.7)
    39.5 (36.1 to 42.9)
    Notes
    [1] - ITT analysis group
    [2] - ITT population
    Statistical analysis title
    		 Primary Analysis - Regression model
    Statistical analysis description
    The ITT population includes all participants who provided primary endpoint data (SNOT-22 at 6 months). The ITT primary analysis adjusts for baseline stratification factors (NOSE severity category and gender) and SNOT-22 score.
    Comparison groups
    Septoplasty v Medical Management
    Number of subjects included in analysis
    307
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [3]
    P-value
    		 < 0.0001 [4]
    Method
    		 Regression, Linear
    Parameter type
    		 Median difference (final values)
    Point estimate
    -20.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -23.63
         upper limit
    		 -16.4
    Variability estimate
    Standard error of the mean
    Dispersion value
    1.836
    Notes
    [3] - The analysis compares SNOT-22 scores at 6 months, by arm, adjusted for stratification variables (NOSE severity and gender) and baseline SNOT-22 scores, for the ITT population. The minimal clinically important difference (MCID) is a difference of 9 points for the SNOT-22 score between the 2 arms.
    [4] - Highly statistically significant effect of septoplasty, with scores on average 20 units less than those in the medical management arm (while holding all other variables the same). Lower 95% CI limit is -16.4, below the MCID of 9 points (superiority).

    Secondary: NOSE score at 6 months

    		 Close Top of page
    End point title
    		 NOSE score at 6 months
    End point description
    The Nasal Obstruction Symptom Evaluation (NOSE) score is a patient reported outcome measure of nasal obstruction symptoms. NOSE consists of five questions that are answered on a scale from “0” (not a problem) up to “4” (severe problems). The total score is generated by adding all item values and multiplying the raw score with 5. The final score is within a range from 0 to 100. A score of 0 indicates no obstructive nasal problems and a score of 100 implies severe problems.
    End point type
    Secondary
    End point timeframe
    NOSE score at 6 months post-randomisation
    End point values
    		 Septoplasty Medical Management
    Number of subjects analysed
    145 [5]
    144 [6]
    Units: total score
        arithmetic mean (confidence interval 95%)
    29.0 (24.9 to 33.1)
    62.2 (58.3 to 66.2)
    Notes
    [5] - ITT population
    [6] - ITT population
    No statistical analyses for this end point

    Secondary: SNOT-22 score at 12 months

    		 Close Top of page
    End point title
    		 SNOT-22 score at 12 months
    End point description
    The 22-item Sinonasal outcome test (SNOT-22) is a validated patient reported questionnaire, used to assess general sinonasal symptoms. SNOT-22 consists of 22 questions that are answered on a scale from “0” (no problem) up to “5” (problem as bad as it can be). The total score is generated by adding all item values. The total can range from 0 (no problem) to 110 (problem as severe as it can be).
    End point type
    Secondary
    End point timeframe
    12 months post-randomisation
    End point values
    		 Septoplasty Medical Management
    Number of subjects analysed
    119 [7]
    125 [8]
    Units: total score
        arithmetic mean (confidence interval 95%)
    21.2 (17.7 to 24.6)
    30.4 (26.6 to 34.3)
    Notes
    [7] - ITT population
    [8] - ITT population
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    All adverse events (AEs) and adverse reactions (ARs) occurring from randomisation (baseline) through to the end of trial participation at 12 months (Visit 3).
    Adverse event reporting additional description
    Adverse events were coded using the MedDRA dictionary and are presented by preferred term, grouped by system organ class.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    Reporting groups
    Reporting group title
    Septoplasty
    Reporting group description
    		 The surgical intervention under investigation was septoplasty, plus/minus unilateral turbinate reduction.

    Reporting group title
    Medical Management
    Reporting group description
    		 Mometasone fuorate spray, taken twice daily at 100mcg (2 sprays in each nostril twice daily ) for 6 weeks followed by 2 sprays in each nostril once daily or 1 spray in each nostril twice daily for the remainder of the 6 month intervention period.

    Serious adverse events
    		 Septoplasty Medical Management
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 166 (6.63%)
    5 / 186 (2.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Injury, poisoning and procedural complications
    Abdominal trauma
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Anaesthetic complication
         subjects affected / exposed
    3 / 166 (1.81%)
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    3 / 3
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postoperative bleeding
         subjects affected / exposed
    5 / 166 (3.01%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    5 / 5
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vasovagal episode
         subjects affected / exposed
    2 / 166 (1.20%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Inappropriate hospital admission
    Additional description: 2 participants in the surgical arm were admitted to hospital overnight after receiving the surgical intervention. These admissions were an administrative oversight by the hospital; the surgical intervention is planned as a day case.
         subjects affected / exposed
    2 / 166 (1.20%)
    0 / 186 (0.00%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Polypharmacy overdose
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Infection
         subjects affected / exposed
    2 / 166 (1.20%)
    2 / 186 (1.08%)
         occurrences causally related to treatment / all
    2 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Septoplasty Medical Management
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    112 / 166 (67.47%)
    77 / 186 (41.40%)
    Surgical and medical procedures
    Nose deformity
    Additional description: Nose shape/asymmetry
         subjects affected / exposed
    4 / 166 (2.41%)
    0 / 186 (0.00%)
         occurrences all number
    4
    0
    Varicose vein operation
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Tooth extraction
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Antibiotic prophylaxis
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Nasal discomfort
         subjects affected / exposed
    11 / 166 (6.63%)
    5 / 186 (2.69%)
         occurrences all number
    19
    5
    Pain
         subjects affected / exposed
    9 / 166 (5.42%)
    7 / 186 (3.76%)
         occurrences all number
    12
    7
    Nasal induced Infection/fever/temperature
         subjects affected / exposed
    11 / 166 (6.63%)
    7 / 186 (3.76%)
         occurrences all number
    11
    7
    Numbness
         subjects affected / exposed
    4 / 166 (2.41%)
    1 / 186 (0.54%)
         occurrences all number
    4
    1
    Swelling
    Additional description: Swelling
         subjects affected / exposed
    3 / 166 (1.81%)
    0 / 186 (0.00%)
         occurrences all number
    3
    0
    Nasal septum perforation
    Additional description: Perforation
         subjects affected / exposed
    2 / 166 (1.20%)
    0 / 186 (0.00%)
         occurrences all number
    2
    0
    Adhesion
    Additional description: Adhesion/synechiae
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Fatigue
    Additional description: Tiredness/fatigue
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    other
    Additional description: admitted overnight to hospital after surgical intervention due to pre-existing condition
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
    Additional description: Epistaxis/bleeding/clot
         subjects affected / exposed
    10 / 166 (6.02%)
    20 / 186 (10.75%)
         occurrences all number
    13
    20
    Rhinorrhoea
    Additional description: Rhinorrhea/mucus
         subjects affected / exposed
    9 / 166 (5.42%)
    5 / 186 (2.69%)
         occurrences all number
    9
    5
    Nasal dryness
    Additional description: Dry nose/itching/crusting
         subjects affected / exposed
    1 / 166 (0.60%)
    5 / 186 (2.69%)
         occurrences all number
    1
    6
    Nasal congestion
    Additional description: Blocked nose
         subjects affected / exposed
    5 / 166 (3.01%)
    0 / 186 (0.00%)
         occurrences all number
    6
    0
    Asthma
    Additional description: exacerbation
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Psychiatric disorders
    Anxiety disorder
    Additional description: Anxiety/depression
         subjects affected / exposed
    0 / 166 (0.00%)
    3 / 186 (1.61%)
         occurrences all number
    0
    3
    Injury, poisoning and procedural complications
    Post procedural complication
    Additional description: Sense of smell/taste
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    2
    0
    shoulder injury
    Additional description: Muscular strain Right Shoulder following MVA
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Cardiac disorders
    ECG changes
    Additional description: ECG changes post-induction of anaesthesia
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
    Additional description: Headache
         subjects affected / exposed
    6 / 166 (3.61%)
    2 / 186 (1.08%)
         occurrences all number
    6
    2
    Dizziness
    Additional description: Dizziness
         subjects affected / exposed
    2 / 166 (1.20%)
    0 / 186 (0.00%)
         occurrences all number
    2
    0
    vasovagal episode
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Hypoglossal nerve paralysis
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Insomnia
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Blood and lymphatic system disorders
    Osteopenia
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Ear and labyrinth disorders
    Ear discomfort
    Additional description: Ear blocked/tinnitus/Labyrinthitis
         subjects affected / exposed
    3 / 166 (1.81%)
    0 / 186 (0.00%)
         occurrences all number
    3
    0
    Gastrointestinal disorders
    reflux
    Additional description: Reflux/heartburn
         subjects affected / exposed
    0 / 166 (0.00%)
    4 / 186 (2.15%)
         occurrences all number
    0
    4
    Nausea
    Additional description: Nausea
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 186 (0.54%)
         occurrences all number
    1
    1
    Skin and subcutaneous tissue disorders
    mouth sores
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Dermatitis
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Endocrine disorders
    Fatty Liver
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    diabetes type 2
         subjects affected / exposed
    1 / 166 (0.60%)
    1 / 186 (0.54%)
         occurrences all number
    1
    1
    Hypertension
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Liver function test abnormal
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Vitamin D deficiency
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Musculoskeletal and connective tissue disorders
    Subluxation of left shoulder
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    shoulder pain
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Arthritis
    Additional description: left hip
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Back injury
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Face injury
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    Muscle injury
    Additional description: right hip
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Sciatica
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Fibula fracture
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Nasal injury
    Additional description: Bruising to the nose after a fall
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Wrist fracture
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Pain
    Additional description: Pain in finger bones
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0
    Infections and infestations
    Infection
    Additional description: Infection/fever/temperature
         subjects affected / exposed
    10 / 166 (6.02%)
    8 / 186 (4.30%)
         occurrences all number
    11
    8
    Cough
    Additional description: Cough/cold/flu
         subjects affected / exposed
    6 / 166 (3.61%)
    5 / 186 (2.69%)
         occurrences all number
    9
    5
    bites to ankles
         subjects affected / exposed
    0 / 166 (0.00%)
    1 / 186 (0.54%)
         occurrences all number
    0
    1
    COVID-19
         subjects affected / exposed
    1 / 166 (0.60%)
    0 / 186 (0.00%)
         occurrences all number
    1
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    20 Nov 2017
    - Change of Senior Statistician. - Section 8.2 - updated wording on the frequency of Sterimar dosing to be consistent with the remainder of the protocol. - Section 11.2.1 Analysis of the Primary Outcome Measure. Update to the wording for the range of NOSE values to be consistent with the remainder of the protocol. - Addition of a section to the protocol to state that a NIMP (nasal decongestant spray) will be used at the baseline, 6 month and 12 month follow up visits, and stating the name of the NIMP (Xylometazoline). - Updated exclusion criteria (clarification and addition)
    11 Jun 2018
    - Update to the protocol, Patient Identification Card and letter to GP to clarify that sterimar isotonic nasal spray must be taken before mometasone nasal spray - Update to the protocol and PIS to clarify that patients randomised to septoplasty must have their septoplasty anytime within 8 weeks of randomisation. - Update to the protocol to state that patients who request local anaesthetic for nasal endoscopy may have the nasal endoscopy assessment carried out after the other trial assessments have been completed. - Throughout the protocol, update to change the name of the Sterimar nasal spray from isotonic spray to saline spray. - Update to the protocol - clarification of the pregnancy reporting guidelines to state pregnancy of a female partipant or the female partner of a male participant. - Update protocol – update Reference Safety Information - Change the exclusion criteria from any history of intranasal recreational drug use to any history of intranasal recreational drug use within the past 6 months. - Update protocol to add fainting and vasovagal episodes and group with dizziness as an undesirable effect of general anaesthesia. - Throughout protocol – correct the misspelling of xylometazoline.
    16 Jan 2019
    PROTOCOL (and PIS and ICF where necessary) - removal of references to internal pilot/pilot phase. Replace ‘Safety Monitoring Plan’ with ‘Sponsor Risk Assessment’ and state the RSI for the IMP. - state the risk of septoplasty as the trial intervention compared to standard surgical care. - state the location of the RSI for septoplasty - Remove all references to a pilot phase - widen the window for the 6 month visit – clarify how to securely email consent and eligibility forms to NCTU for monitoring - clarify how participant usage of the nasal sprays will be calculated. Clarify why IMP compliance is not monitored - clarify management of patients between the 6 month and 12 month follow up visits and/or participants who wish to remain in the trial but discontinue allocated treatment. - clarify pregnancy reporting (also in PIS). - removal of all references to arm ‘crossover’. - update Data Protection Act to General Data Protection Regulation (2018). PIS - clarification that the patient should be prepared for treatment from whichever arm they are allocated to and that patients randomised to surgical management should be prepared to have surgery within 8 weeks. ICF - Clarify that if a participant withdraws from the study, data collected up to that point will be kept; addition of a clause stating that, for participants randomised to medical management, they agree to inform the trial team if their partner becomes pregnant. Nasal Spray Instruction - Replace spray instructions with an instruction to refer to the product patient information leaflet.
    16 Oct 2019
    - Update to the the schedule of events and data collection to add an online platform to the methods of completion for the SNOT-22 questionnaire.
    13 Feb 2020
    Change of site PI at the Stockport site
    17 Dec 2020
    - Amendment of the primary outcome analysis. The text 'baseline severity SNOT-22 score as a continuous covariate' has been removed from the secondary analysis sentence to the primary analysis sentence. By adjusting for the baseline values of the primary outcome measure, this makes for a more powerful primary analysis. - 'BMI' as a clinical covariate has been deleted. This is a historical typographical error and participant BMI data has never been collected.

    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.
    All forms of airway clinical assessment and objective testing of nasal airway function were suspended from March 2020 onwards (COVD-19 pandemic). The resultant lower numbers, may have an impact on the statistical precision of the analysis.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32054508
    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.

    European Medicines Agency © 1995-2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA