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An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00132925
Recruitment Status : Completed
First Posted : August 22, 2005
Last Update Posted : January 11, 2011
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE August 18, 2005
First Posted Date  ICMJE August 22, 2005
Last Update Posted Date January 11, 2011
Study Start Date  ICMJE November 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2006)
  • Double-blind phase: Change from baseline in mean daily instantaneous (immediately prior to dosing) Total Nasal Symptom Score (TNSS) over the 4-week double-blind period
  • Open-label phase: The efficacy variable is the global evaluation of efficacy as rated by the physician and the subject
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2006)
  • Change from baseline: in mean daily reflective (previous 24 hours) TNSS over 4-wk double-blind period
  • for mean daily instantaneous and reflective TNSS by week
  • for mean instantaneous and reflective daily scores for nasal stuffiness, nasal discharge, sneezing, nasal itching, and total eye symptoms by week and over four week double-blind period
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis
Official Title  ICMJE An Efficacy and Safety Evaluation of Nasacort AQ 110 µg QD Children Ages 2-5 Years With Perennial Allergic Rhinitis
Brief Summary

The purposes of this study are:

  • To demonstrate the efficacy of once daily administration of Nasacort AQ 110 µg compared with placebo in children 2-5 years of age with perennial allergic rhinitis; and
  • To assess the safety of Nasacort AQ 110 µg in children 2-5 years of age.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Rhinitis, Allergic, Perennial
Intervention  ICMJE Drug: Triamcinolone
Study Arms  ICMJE Not Provided
Publications * Weinstein S, Qaqundah P, Georges G, Nayak A. Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension. Ann Allergy Asthma Immunol. 2009 Apr;102(4):339-47. doi: 10.1016/S1081-1206(10)60340-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 14, 2006)
460
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE February 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects will be male or female children ages 2-5 years with a history of at least 1 year of perennial allergic rhinitis (PAR) with or without seasonal allergic rhinitis (SAR) characterized by nasal stuffiness, nasal discharge, sneezing, nasal itching, and total eye symptoms, and verified by positive skin test or radioallergosorbent test (RAST) to perennial allergen that is present in the subject's environment (documented historical testing performed during the past year will be accepted).
  • Subjects (assisted by a parent/guardian/care provider) must meet an aggregate symptom score of at least 18 (out of a possible 36) for nasal stuffiness, nasal discharge and sneezing for both the reflective (previous 24 hours) and instantaneous symptom scores recorded in the morning
  • Subjects must not have clinically relevant disease other than allergic rhinitis or have clinically relevant deviations from normal on a physical examination.
  • Subjects must not have been recently exposed to rhinitis medications prior to screening
  • Subjects must have no history of hypersensitivity to glucocorticoids or to any excipients of the formulation
  • Subjects undergoing cosyntropin stimulation test must have a morning (8 AM ± 1 hour) pre-stimulation serum cortisol level ≥ 5 µg/dL and 30 minutes post-stimulation serum cortisol level ≥ 18 µg/dL at screening

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

  • Asthma, requiring chronic use of inhaled or systemic corticosteroids in the previous 6 months; upper respiratory tract infection or sinus infection requiring antibiotic therapy within 2 weeks prior to screening or viral upper respiratory tract infection within 7 days of screening.
  • Nasal polyps, deviated septum, or nasal/facial anatomic abnormalities that interfere with symptom evaluation and/or use of intranasal corticosteroids
  • Treatment with more than 2 courses of systemic corticosteroids (each course not exceeding 14 days) within 1 year of screening
  • Use of intranasal or ocular corticosteroids within 2 weeks of screening
  • Use of oral, inhaled, or intravenous corticosteroids within 1 month of screening
  • Use of intramuscular or intra-articular corticosteroids within 3 months of screening
  • Use of high potency dermatological corticosteroids within 1 month of screening
  • Use of oral leukotriene modifiers within 1 week of screening
  • Use of nasal or oral antihistamines or oral or nasal decongestants within 3 days of screening
  • Current or history of cataract or glaucoma
  • Treatment with any investigational product or use of an investigational device within 1 month of screening
  • Immunotherapy, with the exception of a stable maintenance schedule, for at least 1 month prior to screening
  • History of hypersensitivity to glucocorticoids or to any excipients of the formulation
  • Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff or relative thereof directly involved in the conduct of the protocol.

Any waiver of these inclusion and exclusion criteria must be approved by the investigator and the sponsor on a case-by-case basis prior to enrolling the subject. This must be documented by both the sponsor and the investigator.

No subject will be allowed to enroll in this study more than once.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00132925
Other Study ID Numbers  ICMJE XRG5029C_3502
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sanofi
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Phyllis Diener, BS, MT (ASCP) Sanofi
PRS Account Sanofi
Verification Date January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP