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The primary objective of the study was to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo (NASACORT® AQ placebo group) for 12-months.
The secondary objectives were to compare the following in prepubertal participants treated with TAA nasal spray versus placebo:
The study consisted of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered
All participants were provided Children's Claritin® Syrup as a rescue medication. |
|
| TAA-AQ | Active Comparator | 3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered
All participants were provided Children's Claritin® Syrup as a rescue medication. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | Placebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Growth Velocity | Individual participant's growth velocity over double-blind treatment period was calculated using a linear regression of height over time. Height was measured on the same wall-mounted Harpenden stadiometer with the participant barefoot and in light clothing. | Day 1 to end of treatment (Day 360) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Instantaneous Total Nasal Symptom Score (TNSS) | PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:
TNSS was the sum of the individual symptom scores (ranging 0-3), and TNSS ranged from 0 (best outcome) to 12 (worst outcome). A negative value for change represents an improvement in symptoms. |
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Participants meeting the following eligibility criteria were enrolled.
Inclusion criteria:
Exclusion criteria:
The above information was not intended to contain all considerations relevant to potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Akbar Akbary, MD | Sanofi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States |
299 participants were randomized, 298 were treated.
The study was conducted between 14 March 2007 (first subject enrolled) and 12 October 2011 (last subject last visit) at 69 active centers located in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 3 to 9 year old participants with PAR administered
All participants were provided Children's Claritin® Syrup as a rescue medication |
| FG001 | TAA-AQ | 3 to 9 year old participants with PAR administered
All participants were provided Children's Claritin® Syrup as a rescue medication |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 3 to 9 year old participants with PAR administered
All participants were provided Children's Claritin® Syrup as a rescue medication |
| BG001 | TAA-AQ |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Age at screening |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Growth Velocity | Individual participant's growth velocity over double-blind treatment period was calculated using a linear regression of height over time. Height was measured on the same wall-mounted Harpenden stadiometer with the participant barefoot and in light clothing. | The modified intent-to-treat (mITT) population included all intent-to-treat participants who had at least 3 postrandomization visits with recorded height measurements during the double-blind treatment period, excluding those from Good Clinical Practice (GCP) noncompliant sites. | Posted | Least Squares Mean | Standard Error | cm/year | Day 1 to end of treatment (Day 360) |
|
From treatment initiation to 7 days after the last dose of double-blind treatment (double blind treatment period)
Adverse events that developed, worsened, or became serious during the double-blind treatment period or within 7 days after the last dose of double-blind period, i.e. Treatment-emergent adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | 3 to 9 year old participants with PAR administered
All participants were provided Children's Claritin® Syrup as a rescue medication |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
Two study sites with significant GCP noncompliance were reported to the U.S. Food and Drug Administration (FDA) by the Sponsor. A total of 5 treated participants (1 placebo and 4 TAA-AQ) from these 2 study sites were excluded from the analysis.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Transparency Team | sanofi-aventis | Contact-Us@sanofi.com |
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| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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| Placebo | Other | Placebo to TAA-AQ was administered intranasally once daily in each nostril during the double-blind period |
|
| TAA-AQ, Nasacort® AQ | Drug | 110 μg TAA-AQ was administered once daily intranasally (1 spray delivering 55 μg of TAA-AQ in each nostril) during the double-blind treatment period |
|
| Claritin® | Drug | Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used throughout the study on an as needed basis according to the Food and Drug Administration-approved manufacturer's label |
|
| For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment) |
| Change From Baseline in Four Individual Nasal Symptom Scores at the End of Treatment | PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:
Individual symptom scores ranged from 0 (best outcome) to 3 (worst outcome). A negative value for change represents an improvement in symptoms. | For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment) |
| Global Efficacy as Assessed by the Participant (With the Help of a Parent/Guardian/Caregiver) During and at the End of the Double-blind Treatment Period | Global efficacy was assessed by the participant (with the help of a parent/guardian/caregiver) using the following scale:
| Day 120, Day 240 and Day 360 |
| Global Efficacy as Assessed by the Investigator During and at the End of the Double-blind Treatment Period | Global efficacy was assessed by the investigator using the following scale:
| Day 120, Day 240 and Day 360 |
| Percentage of Participants Who Used the Rescue Medication During the Double-blind Phase of the Study | Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary. The percentage of participants who used the rescue medication during each of the study periods is reported. | Baseline (4-6 months before Day 1), double-blind treatment period (Day 1 to Day 360) and follow-up (Day 361 to Day 420) |
| Percentage of Days Participants Used the Rescue Medication During the Double-blind Treatment Phase of the Study | Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary. The percentage of days that participants used the rescue medication during the double-blind treatment phase of the study. | double-blind treatment period (Day 1 to Day 360) |
| 24 Hour Urinary Free Cortisol Levels | Urine cortisol levels was determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours]. | Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420) |
| 24 Hour Cortisol/Creatinine Ratio | Urine cortisol and creatinine levels were determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours]. No normal range is available for cortisol/creatinine ratio. | Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420) |
| Number of Participants With Treatment-emergent Adverse Events (TEAE) | Adverse events that developed, worsened, or became serious during the double-blind treatment period or within 7 days after the last dose of double-blind investigational product (IP) are defined as TEAEs. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:
| From Day 1 to 7 days following end of treatment (Day 360) |
| Lost to Follow-up |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Physician Decision |
|
| Not treated |
|
| Excluded medication |
|
| Non-compliance |
|
| Sponsor decision |
|
| Relocation |
|
3 to 9 year old participants with PAR administered
All participants were provided Children's Claritin® Syrup as a rescue medication |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Age, Customized | Age group at screening. | Number | participants |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Tanner classification at randomization | Tanner classification distinguishes stages of puberty. Each stage differentiates the extent of breast, genitalia and pubic hair growth. Tanner Stage I represents the preadolescent 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. | Number | participants |
|
| OG001 | TAA-AQ | 3 to 9 year old participants with PAR administered
All participants were provided Children's Claritin® Syrup as a rescue medication. |
|
|
|
| Secondary | Change From Baseline in Instantaneous Total Nasal Symptom Score (TNSS) | PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:
TNSS was the sum of the individual symptom scores (ranging 0-3), and TNSS ranged from 0 (best outcome) to 12 (worst outcome). A negative value for change represents an improvement in symptoms. | mITT population with scores available for TNSS: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period with scores available for TNSS, excluding those from GCP noncompliant sites. | Posted | Least Squares Mean | Standard Error | score on a scale | For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment) |
|
|
|
|
| Secondary | Change From Baseline in Four Individual Nasal Symptom Scores at the End of Treatment | PAR symptoms - nasal stuffiness, nasal discharge, sneezing, and nasal itching were scored upon arising in the morning according to the following 4-point scale:
Individual symptom scores ranged from 0 (best outcome) to 3 (worst outcome). A negative value for change represents an improvement in symptoms. | mITT population with available nasal symptom scores: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period with available nasal symptom scores, excluding those from GCP noncompliant sites. | Posted | Least Squares Mean | Standard Error | score on a scale | For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment) |
|
|
|
|
| Secondary | Global Efficacy as Assessed by the Participant (With the Help of a Parent/Guardian/Caregiver) During and at the End of the Double-blind Treatment Period | Global efficacy was assessed by the participant (with the help of a parent/guardian/caregiver) using the following scale:
| mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites. | Posted | Mean | Standard Deviation | score on a scale | Day 120, Day 240 and Day 360 |
|
|
|
|
| Secondary | Global Efficacy as Assessed by the Investigator During and at the End of the Double-blind Treatment Period | Global efficacy was assessed by the investigator using the following scale:
| mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites. | Posted | Mean | Standard Deviation | score on a scale | Day 120, Day 240 and Day 360 |
|
|
|
|
| Secondary | Percentage of Participants Who Used the Rescue Medication During the Double-blind Phase of the Study | Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary. The percentage of participants who used the rescue medication during each of the study periods is reported. | mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites. | Posted | Number | percentage of participants | Baseline (4-6 months before Day 1), double-blind treatment period (Day 1 to Day 360) and follow-up (Day 361 to Day 420) |
|
|
|
| Secondary | Percentage of Days Participants Used the Rescue Medication During the Double-blind Treatment Phase of the Study | Children's Claritin® syrup was provided as a rescue medication to control allergic rhinitis (AR) symptoms and could be used throughout the study on an as needed basis. Use of rescue medication was to be documented in the participant's diary. The percentage of days that participants used the rescue medication during the double-blind treatment phase of the study. | mITT population: All randomized and treated participants with at least 3 post-randomization height measurements during the double-blind treatment period, excluding those from GCP noncompliant sites. | Posted | Mean | Standard Deviation | percentage of days | double-blind treatment period (Day 1 to Day 360) |
|
|
|
| Secondary | 24 Hour Urinary Free Cortisol Levels | Urine cortisol levels was determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours]. | All randomized and treated participants, excluding those from GCP noncompliant sites. | Posted | Mean | Standard Deviation | μg/24 hours | Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420) |
|
|
|
| Secondary | 24 Hour Cortisol/Creatinine Ratio | Urine cortisol and creatinine levels were determined at screening, at the end of treatment, and at follow-up visit using routine laboratory testing. The normal range for urinary free cortisol for 3- to 9-year-olds was considered to be [1.4 - 21 μg/24 hours]. No normal range is available for cortisol/creatinine ratio. | All randomized and treated participants, excluding those from GCP noncompliant sites. | Posted | Mean | Standard Deviation | μg/g Creatinine | Baseline (2 to 6 weeks before Day 1), end of treatment (Day 360), and at follow-up (Day 420) |
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAE) | Adverse events that developed, worsened, or became serious during the double-blind treatment period or within 7 days after the last dose of double-blind investigational product (IP) are defined as TEAEs. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:
| All randomized and treated participants, excluding those from GCP noncompliant sites. | Posted | Number | participants | From Day 1 to 7 days following end of treatment (Day 360) |
|
|
|
| 0 |
| 147 |
| 98 |
| 147 |
| EG001 | TAA-AQ | 3 to 9 year old participants with PAR administered
All participants were provided Children's Claritin® Syrup as a rescue medication | 2 | 146 | 109 | 146 |
| Animal bite | Injury, poisoning and procedural complications | MedDRA 14.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 14.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 14.1 | Non-systematic Assessment |
|
The investigator can independently publish study results from his site after the primary publication by the steering committee, or 12 months after the completion of the study by all sites. He must provide the sponsor a copy of any such publication derived from the study for review and comment at least 45 days (20 days for abstracts) in advance of any submission, and delay publication till the approval of the publication is given in writing by the Sponsor (not to exceed ninety days).
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| Change in Sneezing (N=102, N=103) |
|
| Change in Nasal Itching (N=101, N=104) |
|
Change in Nasal Discharge
| ANCOVA |
| 0.7193 |
| LS Mean Difference |
| -0.04 |
| 2-Sided |
| 95 |
| -0.24 |
| 0.17 |
The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model. |
| No |
| Superiority or Other |
| Change in Sneezing | ANCOVA | 0.4020 | LS Mean Difference | 0.09 | 2-Sided | 95 | -0.12 | 0.29 | The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model. | No | Superiority or Other |
| Change in Nasal Itching | ANCOVA | 0.8854 | LS mean Difference | -0.02 | 2-Sided | 95 | -0.23 | 0.20 | The treatment arm, sex and age group were fixed effects, and baseline value was a covariate in the ANCOVA model. | No | Superiority or Other |
| Day 360 (N=125, N=125) |
|
Statistical analysis for Day 240
| Mixed model for repeated measures |
The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor. |
| 0.1247 |
| 95 |
| No |
| Superiority or Other |
| Statistical analysis for Day 360 | Mixed model for repeated measures | The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor. | 0.0207 | 95 | No | Superiority or Other |
| Day 360 (N=125, N=125) |
|
Statistical Analysis for Day 240
| Mixed model for repeated measures |
The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor. |
| 0.4488 |
| 95 |
| No |
| Superiority or Other |
| Statistical Analysis for Day 360 | Mixed model for repeated measures | 0.0142 | The treatment arm, assessment visit, their interaction, sex and age group were fixed effects, and assessment visit was a repeated factor. | 95 | No | Superiority or Other |
| at follow-up (N=96, N=97) |
|
| at follow-up (N=96, N=97) |
|
| with any TEAE leading to permanent discontinuation |
|
| with any TEAE leading to death |
|
| with investigational product (IP) overdose TEAE |
|