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

NCT00132925 | Completed Phase 3

• 1 other identifier: XRG5029C_3502
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

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.

Conditions

Rhinitis, Allergic, Perennial

Keywords

allergic rhinitis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

Interventions

Triamcinolone DRUG

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis, Inc.

Bridgewater, New Jersey, 08807, United States

Location

Related Publications (1)

• 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.

  PMID: 19441606 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial; Rhinitis, Allergic

Interventions

Triamcinolone

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Phyllis Diener, BS, MT (ASCP)

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 18, 2005
• First Posted: August 22, 2005
• Study Start: November 1, 2003
• Study Completion: February 1, 2006
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

US (1)