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    Clinical Trial Results:
    A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Pharmacodynamic Effect of a 6-week Treatment With Triamcinolone Acetonide Aqueous Nasal Spray 110 μg and 220 μg Once Daily on Basal Hypothalamic-Pituitary-Adrenal (HPA) Axis Function in Children [>=2 to < 12 Years of Age] With Allergic Rhinitis

    Summary
    EudraCT number
    		 2014-004646-98
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    10 Oct 2010

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Apr 2016
    First version publication date
    15 May 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TRICA_L_04286
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01154153
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Sanofi U.S Services Inc.
    Sponsor organisation address
    55 Corporate Drive, Bridgewater, NJ, United States, 08807
    Public contact
    Trial Transparency Team, Sanofi Aventis recherche & Development, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Aventis recherche & Development, Contact-US@sanofi.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Nov 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    10 Oct 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective was to evaluate the effect of a 6-week treatment with TAA-AQ (110 μg) and TAA-AQ (220 μg) once daily (QD) versus placebo on hypothalamic-pituitary-adrenal (HPA) axis function as measured by serum cortisol AUC(0-24 hr) in children (>=2 to <12 years old) with allergic rhinitis (AR).
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of pediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimized. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimize distress and discomfort.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Jun 2010
    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 States: 140
    Worldwide total number of subjects
    140
    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)
    140
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was performed in 8 study centres in the United States.

    Pre-assignment
    Screening details
    		 Of 179 screened subjects, 31 subjects were screen failures and 8 subjects did not continue as the limit on the number of subjects to be randomized had been reached. 140 subjects were randomized.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Placebo
    Arm description
    		 Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Claritin® Syrup
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    Children's Claritin® Syrup [5 mg of loratadine per 5 mL] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis, according to the Food and Drug Administration-approved manufacturer's label.

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase. For children who were >=2 to <6 years old, 1 spray/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase. For children who were >= 6 yrs to <12 years old, either 1 spray/nostril or 2 sprays/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase.

    Arm title
    		 TAA-AQ
    Arm description
    		 Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase.

    Investigational medicinal product name
    Claritin® Syrup
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Syrup
    Routes of administration
    Oral use
    Dosage and administration details
    Children's Claritin® Syrup [5 mg of loratadine per 5 mL] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis, according to the Food and Drug Administration-approved manufacturer's label.

    Investigational medicinal product name
    Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ)
    Investigational medicinal product code
    XRG5029
    Other name
    Pharmaceutical forms
    Nasal spray
    Routes of administration
    Nasal use
    Dosage and administration details
    Treatment assignment was randomized with stratification by sex and age group (>=2 to <6, >=6 to <12 years old). - For children who were >=2 to <6 years old, 1 spray/nostril (110 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase. - For children who were >=6 yrs to <12 years old, either 1 spray/nostril (110 µg TAA-AQ) or 2 sprays/nostril (220 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase.

    Number of subjects in period 1
    		Placebo TAA-AQ
    Started
    71
    69
    Completed
    66
    66
    Not completed
    5
    3
         Poor compliance to protocol
    2
    -
         Unable to use labs
    2
    3
         'Withdrew consent '
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.

    Reporting group title
    TAA-AQ
    Reporting group description
    		 Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.

    Reporting group values
    		 Placebo TAA-AQ Total
    Number of subjects
    		 71 69 140
    Age categorical
    Units: Subjects
        >=2 to < 4 years
    		 6 5 11
        >=4 to < 6 years
    		 15 16 31
        >=6 to < 12 years
    		 50 48 98
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 7.3 ( 2.7 ) 7.1 ( 2.5 ) -
    Gender categorical
    Units: Subjects
        Female
    		 29 28 57
        Male
    		 42 41 83
    Race/Ethnicity
    Units: Subjects
        American Indian or Alaska Native
    		 0 0 0
        Asian
    		 2 0 2
        Native Hawaiian or Other Pacific Islander
    		 0 0 0
        Black or African American
    		 22 22 44
        White
    		 43 42 85
        Others
    		 4 5 9
    Region of Enrollment
    Units: Subjects
        United States
    		 71 69 140
    Tanner Classification
    Tanner classification distinguishes stages of puberty. Each stage represents the extent of breast, genitalia and pubic hair growth. Tanner Stage I represents the pre-adolescent stage where breast, genitalia and pubic hair growth are of the same size and shape as in early childhood and in Tanner Stage 5 breasts and genitalia are of adult shape and size, and pubic hair is adult in quantity (mature stage). Stages 2, 3 and 4 are intermediate stages.
    Units: Subjects
        Stage 1
    		 55 60 115
        Stage 2
    		 12 9 21
        Stage 3
    		 4 0 4
        Stage 4
    		 0 0 0
        Stage 5
    		 0 0 0
    Primary Allergic Rhinitis Diagnosis
    Subjects diagnosed with perennial allergic rhinitis (PAR); and seasonal allergic rhinitis (SAR).
    Units: Subjects
        PAR only
    		 11 12 23
        SAR only
    		 5 3 8
        Both PAR and SAR
    		 55 54 109
    Time from the first Allergic Rhinitis symptom to Visit 1
    For subjects with both PAR and SAR, it is the longest time. A missing month of the first symptom start date was imputed as December and a missing day was imputed as the last date of the month.
    Units: years
        arithmetic mean (standard deviation)
    		 4.82 ( 2.7 ) 4.79 ( 2.48 ) -

    End points

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    End points reporting groups
    Reporting group title
    Placebo
    Reporting group description
    		 Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.

    Reporting group title
    TAA-AQ
    Reporting group description
    		 Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.

    Primary: Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline

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    End point title
    		 Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline
    End point description
    Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times. Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC[0-24 hr] at 6 weeks postrandomization)/(Serum Cortisol AUC[0-24 hr] at 1-3 days prerandomization). Log transformation was used for the analysis. The per protocol (PP) population included all randomized subjects who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.
    End point type
    Primary
    End point timeframe
    1-3 days prerandomization and 6 weeks postrandomization
    End point values
    		 Placebo TAA-AQ
    Number of subjects analysed
    61
    65
    Units: Ratio
        geometric mean (full range (min-max))
    0.938 (0.39 to 1.63)
    0.898 (0.48 to 4.45)
    Statistical analysis title
    		 TAA-AQ vs Placebo
    Statistical analysis description
    Missing values imputed with multiple imputation. AUC(0-24hr) was calculated for each imputation & analyzed with log-transformation using ANCOVA model with treatment (Tx), sex, age group as fixed effects & log-transformed baseline value as covariate. Mean difference in log scale between treatments & its SE were calculated by LS mean. Results from multiply imputed data were combined using SAS procedure MIANALYZE. Tx ratio was calculated as exponential of mean difference between Tx in log scale.
    Comparison groups
    Placebo v TAA-AQ
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    Method
    Parameter type
    		 Treatment Ratio of Geometric mean
    Point estimate
    0.966
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.892
         upper limit
    		 1.045

    Secondary: Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)

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    End point title
    		 Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)
    End point description
    Every morning, subjects rated the severity of symptoms experienced over the previous 24 hours using scale from 0-3, where 0=symptoms absent, 1=mild, 2=moderate, and 3=severe symptoms (interfere with daily living or sleep) for each symptom (nasal congestion, nasal itching, sneezing, and runny nose). The rTNSS was the sum of the individual symptom scores, ranged from 0-12 (where 12 reflected the worst symptoms). Change from baseline in the rTNSS = mean rTNSS (double-blind treatment phase) - mean rTNSS (screening phase).The per protocol (PP) population included all randomized subjects who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.
    End point type
    Secondary
    End point timeframe
    From 8-24 days prerandomization up to 6 weeks postrandomization
    End point values
    		 Placebo TAA-AQ
    Number of subjects analysed
    61
    65
    Units: Score on a scale
        arithmetic mean (standard deviation)
    -0.22 ( 1.12 )
    -1.07 ( 1.66 )
    Statistical analysis title
    		 TAA-AQ vs Placebo
    Statistical analysis description
    For ANCOVA, treatment arm, randomization strata were fixed effects and baseline value was a covariate.
    Comparison groups
    Placebo v TAA-AQ
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0007
    Method
    		 ANCOVA
    Parameter type
    		 LS Mean Difference
    Point estimate
    -0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -1.34
         upper limit
    		 -0.37

    Secondary: Number of Subjects by Relief Level as Evaluated by the Physician

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    End point title
    		 Number of Subjects by Relief Level as Evaluated by the Physician
    End point description
    Efficacy of treatment was assessed by the physician using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present). The per protocol (PP) population included all randomized subjects who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.
    End point type
    Secondary
    End point timeframe
    At end of study (43-50 days after randomization)
    End point values
    		 Placebo TAA-AQ
    Number of subjects analysed
    61
    65
    Units: Subjects
        Relief Level 0 (No relief)
    11
    9
        Relief Level 1 (Slight relief)
    18
    13
        Relief Level 2 (Moderate relief)
    16
    20
        Relief Level 3 (Marked relief)
    13
    17
        Relief Level 4 (Complete relief)
    3
    6
    Statistical analysis title
    		 TAA-AQ vs Placebo
    Comparison groups
    Placebo v TAA-AQ
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1332 [1]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [1] - Based on the ordinal evaluation score and adjusted for the randomization strata.

    Secondary: Number of Subjects by Relief Level as Evaluated by the Subject

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    End point title
    		 Number of Subjects by Relief Level as Evaluated by the Subject
    End point description
    Efficacy of treatment was assessed by the subject using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present). The per protocol (PP) population included all randomized subjects who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.
    End point type
    Secondary
    End point timeframe
    At end of study (43-50 days after randomization)
    End point values
    		 Placebo TAA-AQ
    Number of subjects analysed
    61
    65
    Units: Subjects
        Relief level 0 (No relief)
    9
    5
        Relief level 1 (Slight relief)
    17
    22
        Relief level 2 (Moderate relief)
    16
    13
        Relief level 3 (Marked relief)
    14
    16
        Relief level 4 (Complete relief)
    5
    9
    Statistical analysis title
    		 TAA-AQ vs Placebo
    Comparison groups
    Placebo v TAA-AQ
    Number of subjects included in analysis
    126
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3314 [2]
    Method
    		 Cochran-Mantel-Haenszel
    Confidence interval
    Notes
    [2] - Based on the ordinal evaluation score and adjusted for the randomization strata.

    Secondary: Number of Subjects Using Rescue Medication

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    End point title
    		 Number of Subjects Using Rescue Medication
    End point description
    The number of subjects using the rescue medication (Claritin®) during the single-blind screening phase (the time from 8-24 days before randomization up to the day before randomization) and during the double-blind treatment phase (the time from randomization to end of study). The per protocol (PP) population included all randomized subjects who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.
    End point type
    Secondary
    End point timeframe
    From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization)
    End point values
    		 Placebo TAA-AQ
    Number of subjects analysed
    61
    65
    Units: Subjects
        Prerandomization period
    8
    8
        Postrandomization period
    24
    19
    No statistical analyses for this end point

    Secondary: The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase

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    End point title
    		 The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase
    End point description
    The percent of days of rescue medication used during the double-blind treatment phase was calculated. For subjects who did not use any rescue medication, the percentage of days using rescue medication was set to be 0. The per protocol (PP) population included all randomized subjects who took at least one dose of study medication and had no major protocol violations. Major protocol violations were those deemed most likely to affect the interpretation of the results and included poor compliance, use of prohibited medication, missing blood samples.
    End point type
    Secondary
    End point timeframe
    From randomization to 43-50 days postrandomization
    End point values
    		 Placebo TAA-AQ
    Number of subjects analysed
    61
    65
    Units: Percentage of days
        arithmetic mean (standard deviation)
    4.02 ( 12.77 )
    3.07 ( 11.82 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All Adverse Events (AE) were collected from signature of the informed consent form up to the final visit (Days 43 to 50 post-randomization) regardless of seriousness or relationship to investigational product.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.1
    Reporting groups
    Reporting group title
    TAA-AQ
    Reporting group description
    		 Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.

    Reporting group title
    Placebo
    Reporting group description
    		 Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.

    Serious adverse events
    		 TAA-AQ Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 71 (1.41%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Injury, poisoning and procedural complications
    Humerus Fracture
         subjects affected / exposed
    0 / 69 (0.00%)
    1 / 71 (1.41%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 TAA-AQ Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    7 / 69 (10.14%)
    12 / 71 (16.90%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 69 (2.90%)
    4 / 71 (5.63%)
         occurrences all number
    7
    4
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 69 (5.80%)
    2 / 71 (2.82%)
         occurrences all number
    4
    2
    Respiratory, thoracic and mediastinal disorders
    Epistaxis
         subjects affected / exposed
    3 / 69 (4.35%)
    7 / 71 (9.86%)
         occurrences all number
    5
    11

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    21 Jan 2010
    - The primary objective of this study: To evaluate the effect of a 6-week treatment with triamcinolone acetonide aqueous nasal spray versus placebo on basal hypothalamic-pituitaryadrenal (HPA) axis function as measured by plasma cortisol area under the curve (AUC[0-24hr]). - Inclusion of children down to 2 years of age in study population. - Inclusion of the subject’s diaries and assessment of global efficacy in drug compliance assessment. - Statistical analyses was to be performed with and without log transformation of the plasma cortisol (24-hour plasma cortisol and 24-hour plasma cortisol trough).
    18 May 2010
    - Total blood volume to be collected per subject for the study would be approximately no more than 98 mL. - Total blood volume by test would be: 84 mL for serum cortisol; 9 mL for clinical laboratoryanalytes; 5 mL for ImmunoCAP. - Cortisol measurements was to be performed on blood serum and not blood plasma.
    12 Jul 2010
    - The 24-hour blood draw schedule was revised to allow for up to 2 extra drawings of blood samples if needed. These extra samples were to be drawn only if the initial blood sample was inadequate or mishandled, as long as the ± 15 minute time frame for that pre-specified time point had not expired. - Exclusion criteria was modified for morning serum cortisol in alignment with published literature and the previous pivotal Phase 3 protocol XRG5029C/3502.

    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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    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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