Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)

NCT00449072 | Completed Phase 4 Results

• 1 other identifier: XRG5029C_3503
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study was to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with perennial allergic rhinitis (PAR) treated with triamcinolone acetonide (TAA) nasal spray (NASACORT® AQ 110 μg treatment group) or placebo (NASACORT® AQ placebo group) for 12-months. The secondary objectives were to compare the following in prepubertal participants treated with TAA nasal spray versus placebo:

• the 24-hour urinary free cortisol levels and the cortisol/creatinine ratio (to measure the Hypothalamic-Pituitary Adrenal \[HPA\] axis function)
• the rate of treatment-emergent-adverse-events (TEAE)
• global efficacy rated by the investigator and the participant separately
• the rate of use of rescue medication during the study

Conditions

Rhinitis, Allergic, Perennial

Outcome Measures

Primary Outcomes (1)

• Growth Velocity

  Individual participant's growth velocity over double-blind treatment period was calculated using a linear regression of height over time. Height was measured on the same wall-mounted Harpenden stadiometer with the participant barefoot and in light clothing.

  Day 1 to end of treatment (Day 360)

Secondary Outcomes (9)

• Change From Baseline in Instantaneous Total Nasal Symptom Score (TNSS)

  For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)

• Change From Baseline in Four Individual Nasal Symptom Scores at the End of Treatment

  For 7 days prior to randomization (Baseline) and everyday for 7 days prior to Day 360 (end of treatment)

• Global Efficacy as Assessed by the Participant (With the Help of a Parent/Guardian/Caregiver) During and at the End of the Double-blind Treatment Period

  Day 120, Day 240 and Day 360

• Global Efficacy as Assessed by the Investigator During and at the End of the Double-blind Treatment Period

  Day 120, Day 240 and Day 360

• Percentage of Participants Who Used the Rescue Medication During the Double-blind Phase of the Study

  Baseline (4-6 months before Day 1), double-blind treatment period (Day 1 to Day 360) and follow-up (Day 361 to Day 420)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered * Placebo in the baseline/screening period to demonstrate administration of investigational product (IP) with the nasal spray bottle * Placebo in the double-blind treatment period All participants were provided Children's Claritin® Syrup as a rescue medication.

Other: Placebo; Drug: Claritin®

TAA-AQ

ACTIVE COMPARATOR

3 to 9 year old participants with Perennial Allergic Rhinitis (PAR) administered * Placebo in the baseline/screening period to demonstrate administration of IP with the nasal spray bottle * Triamcinolone acetonide (TAA-AQ) in the double-blind treatment period All participants were provided Children's Claritin® Syrup as a rescue medication.

Other: Placebo; Drug: TAA-AQ, Nasacort® AQ; Drug: Claritin®

Interventions

Placebo OTHER

Placebo to TAA-AQ was administered once at the study site in each nostril during the baseline/screening period to demonstrate intranasal IP administration

Placebo; TAA-AQ

TAA-AQ, Nasacort® AQ DRUG

110 μg TAA-AQ was administered once daily intranasally (1 spray delivering 55 μg of TAA-AQ in each nostril) during the double-blind treatment period

TAA-AQ

Claritin® DRUG

Participants were provided Children's Claritin® Syrup (5 mg of loratadine per 5 mL), as rescue medication for the relief of allergic rhinitis (AR) symptoms, and could be used throughout the study on an as needed basis according to the Food and Drug Administration-approved manufacturer's label

Placebo; TAA-AQ

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male participants \[3 years to \<= 9 years + 0 days old\] at Visit 1 and no older than \[9 years + 120 days\] at Visit 3; and, female participants \[3 years to \<= 8 years + 0 days old\] at Visit 1 and no older than \[8 years + 120 days\] at Visit 3: all sexually prepubertal (ie, Stage 1 of Tanner Classification of sexual maturity) at Visit 1 and Visit 3. A 5-day extension to the age upper bound was permitted under certain circumstances to enable scheduling of Visits 1 and 3
• At least a one year history of PAR as assessed and documented by the investigator (with or without seasonal allergic rhinitis \[SAR\])
• Positive skin test (prick or intradermal) to a perennial allergen that was present in the participant's environment. A skin test was considered positive if the wheal produced by the allergen was equal to or greater than that caused by positive control (histamine) or was at least 3 mm (prick test) or 7 mm (intradermal test) greater than the wheal of negative control (saline). If a skin test could not be performed, the radioallergosorbent test (RAST) would be used as an alternative. Documented historical skin testing or RAST performed during the past year were acceptable
• Height within the 3rd and 97th percentiles at screening (Visit 1), Visit 2, and at randomization (Visit 3)
• Symptomatic (daily AM instantaneous total nasal symptom score was \>= 4 out of 12) on any 4 out of the last 7 consecutive days immediately prior to and including the morning of Visit 3. Symptom ratings were to be completed with the help of a parent/guardian/caregiver
• Written informed consent and ability of parent or legal guardian of the participant to give a written informed consent before any study related procedures. Participants 7 years of age and older must have provided a signed assent form
• Participants had to be toilet-trained

You may not qualify if:

• Gross nasal anatomical deformities including large polyposis and marked deviated septum
• History of or current cataract or glaucoma
• History of hypersensitivity to the corticosteroids or to any excipient of the investigational product
• Participant was the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
• Height, weight, or body mass index (BMI)-for-age below the 3rd or above the 97th percentile at Visits 1, 2, or 3
• Treatment with systemic corticosteroids (oral, intravenous, intramuscular, or intra-articular) within 3 months prior to Visit 1
• Treatment with inhaled, intranasal, or high potency topical corticosteroid exposure within 6 weeks prior to Visit 1. Mild asthma that was well-controlled and without the use of inhaled corticosteroids within 6 weeks before screening (Visit 1).
• Immunotherapy, except stable (\>=1 month) maintenance schedule before Visit 1.
• Treatment with any substance before Visit 1 that might have affected growth velocity and/or linear growth, such as, but not be limited to methylphenidate hydrochloride, thyroid hormone, growth hormone, anabolic steroids, calcitonin, estrogens, progestins, bisphosphonates, anticonvulsants, or phosphate-binding antacids
• Treatment with any investigational product or device in the 30 days before Visit 1 or at any time throughout the duration of this trial (Visit 1 through Visit 11).
• Bone age as assessed by X-ray of the left hand and wrist that was outside +/- 1.5 years of participants chronological age at Visit 2. Right hand and wrist were to be radiographed in the event of bone injury to the left hand or wrist.
• Unresolved upper respiratory tract infection, sinus infection or nasal candidiasis (i.e., symptomatic or under treatment) within the last 2 weeks before Visit 3.
• Participants or parent/guardian/caregiver unable to demonstrate correct administration of the investigational product at Visit 1.
• Concomitant disease other than PAR which could have interfered with the study procedures or outcomes as determined by the investigator.
• History of hospitalization due to asthma within 1 year before screening (Visit 1).

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

Loratadine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cyproheptadine; Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

Two study sites with significant GCP noncompliance were reported to the U.S. Food and Drug Administration (FDA) by the Sponsor. A total of 5 treated participants (1 placebo and 4 TAA-AQ) from these 2 study sites were excluded from the analysis.

Results Point of Contact

• Title: Trial Transparency Team
• Organization: sanofi-aventis

Contact-Us@sanofi.com

Study Officials

• Akbar Akbary, MD

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: March 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 10, 2012
• Results First Posted: August 7, 2012

Record last verified: 2011-10

Locations

US (1)