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

January 10, 2011 updated by: Sanofi

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

460

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Investigators

  • Study Director: Phyllis Diener, BS, MT (ASCP), Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2003

Study Completion

February 1, 2006

Study Registration Dates

First Submitted

August 18, 2005

First Submitted That Met QC Criteria

August 19, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

January 11, 2011

Last Update Submitted That Met QC Criteria

January 10, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XRG5029C_3502

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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