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

History of Changes

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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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
Number of Participants [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
Primary Allergic Rhinitis (AR) diagnosis ^[2] [units: Participants]
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 ^[3] [units: Years] Mean ± Standard Deviation	4.82 ± 2.70	4.79 ± 2.48	4.80 ± 2.59

[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.
[2]	Participants diagnosed with perennial allergic rhinitis (PAR); and seasonal allergic rhinitis (SAR).
[3]	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 ]

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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 ]

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3. Secondary:

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

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4. Secondary:

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

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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) ]

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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The investigator shall have the right to independently publish study results from his site after a multicenter publication, or 12 months after the completion of the study by all sites. He must provide the sponsor a copy of any such publication for review and comment at least 45 days (for abstracts -20 days) in advance of any submission for publication. The Sponsor may request for the publication to be delayed for a limited time, not to exceed 90 days to preserve its proprietary rights.

Limitations and Caveats

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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Results Point of Contact:

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

No publications provided

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

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