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

Information source: Sanofi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rhinitis, Allergic, Perennial

Intervention: Triamcinolone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanofi

Official(s) and/or principal investigator(s):
Phyllis Diener, BS, MT (ASCP), Study Director, Affiliation: Sanofi

Summary

The purposes of this study are:

- To demonstrate the efficacy of once daily administration of Nasacort AQ 110 g compared

with placebo in children 2-5 years of age with perennial allergic rhinitis; and

- To assess the safety of Nasacort AQ 110 g in children 2-5 years of age.

Clinical Details

Official title: An Efficacy and Safety Evaluation of Nasacort AQ 110 g QD Children Ages 2-5 Years With Perennial Allergic Rhinitis

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Primary outcome:

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 outcome:

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

Eligibility

Minimum age: 2 Years. Maximum age: 5 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Sanofi-Aventis, Inc., Bridgewater, New Jersey 08807, United States
Additional Information

Starting date: November 2003
Last updated: January 10, 2011

Page last updated: August 23, 2015

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