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Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01154153
First received: June 22, 2010
Last updated: June 21, 2012
Last verified: June 2012
Results First Received: September 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Rhinitis, Allergic, Perennial and/or Seasonal
Interventions: Drug: Placebo nasal spray
Drug: Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ)
Drug: Claritin® Syrup

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was performed in 8 study centers in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
179 participants were screened in this study. 31 participants were screen failures and 8 participants did not continue to as the limit on the number of participants to be randomized had been reached. 140 participants were randomized.

Reporting Groups
  Description
Placebo 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.
TAA-AQ 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.

Participant Flow:   Overall Study
    Placebo   TAA-AQ
STARTED   71   69 
COMPLETED   66   66 
NOT COMPLETED   5   3 
Poor compliance to protocol                2                0 
Unable to use labs                2                3 
Withdrew consent                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo 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.
TAA-AQ 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.
Total Total of all reporting groups

Baseline Measures
   Placebo   TAA-AQ   Total 
Overall Participants Analyzed 
[Units: Participants]
 71   69   140 
Age 
[Units: Years]
Mean (Standard Deviation)
 7.3  (2.7)   7.1  (2.5)   7.2  (2.6) 
Age, Customized 
[Units: Participants]
     
>=2 to < 4 years   6   5   11 
>=4 to < 6 years   15   16   31 
>=6 to < 12 years   50   48   98 
Gender 
[Units: Participants]
     
Female   29   28   57 
Male   42   41   83 
Race/Ethnicity, Customized 
[Units: Participants]
     
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: Participants]
     
United States   71   69   140 
Tanner Classification [1] 
[Units: Participants]
     
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 
[1] 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.
Primary Allergic Rhinitis (AR) diagnosis [1] 
[Units: Participants]
     
PAR only   11   12   23 
SAR only   5   3   8 
Both PAR and SAR   55   54   109 
[1] Participants diagnosed with perennial allergic rhinitis (PAR); and seasonal allergic rhinitis (SAR).
Time from the first Allergic Rhinitis symptom to Visit 1 [1] 
[Units: Years]
Mean (Standard Deviation)
 4.82  (2.70)   4.79  (2.48)   4.80  (2.59) 
[1] For participants 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.


  Outcome Measures
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1.  Primary:   Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline   [ Time Frame: 1-3 days prerandomization and 6 weeks postrandomization ]

2.  Secondary:   Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)   [ Time Frame: From 8-24 days prerandomization up to 6 weeks postrandomization ]

3.  Secondary:   Number of Participants by Relief Level as Evaluated by the Physician   [ Time Frame: At end of study (43-50 days after randomization) ]

4.  Secondary:   Number of Participants by Relief Level as Evaluated by the Participant   [ Time Frame: At end of study (43-50 days after randomization) ]

5.  Secondary:   Number of Participants Using Rescue Medication   [ Time Frame: From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization) ]

6.  Secondary:   The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase   [ Time Frame: From randomization to 43-50 days postrandomization ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Trial Transparency Team
Organization: sanofi-aventis
e-mail: Contact-US@sanofi.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01154153     History of Changes
Other Study ID Numbers: TRICA_L_04286
Study First Received: June 22, 2010
Results First Received: September 21, 2011
Last Updated: June 21, 2012
Health Authority: United States: Food and Drug Administration