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

Condition(s) targeted: Rhinitis, Allergic, Perennial

Intervention: triamcinolone acetonide (Drug); placebo (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Sanofi-Aventis

Official(s) and/or principal investigator(s):
Tara Semanchik, MBA, Study Director, Affiliation: Sanofi-Aventis

Overall contact:
Public Registry USMA, Email: PublicRegistryUSMA@sanofi-aventis.com

The primary objective of the study is to characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with PAR treated with TAA nasal spray (NASACORT AQ 110 μg treatment group) or placebo (NASACORT AQ placebo group) for 12-months.

Official title: A Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Group Study of the 12 Month Effect of Treatment With Once Daily Triamcinolone Acetonide (NASACORT® AQ Nasal Spray 110 μg) on the Growth Velocity of Children, 3 to 9 Years of Age, With Perennial Allergic Rhinitis (PAR)

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To characterize the difference in prepubescent growth velocity in children 3 to 9 years of age with PAR treated with triamcinolone acetonide (TAA) nasal spray (Nasacort AQ 110 μg) or placebo (Nasacort AQ placebo) for 12 months.

Secondary outcome:

To compare 24 hr urinary free cortisol levels and the cortisol/creatinine ratio in prepubertal subjects treated with TAA nasal spray vs placebo.

To assess the global efficacy of TAA nasal spray vs placebo as rated separately by the investigator and the subject (with the help of a parent/guardian/caregiver) during and at the end of the double-blind treatment period.

To determine the rate of use of rescue medication with TAA nasal spray vs placebo during each phase of the study (baseline, double-blind & follow up)

To determine the rate of treatment-emergent adverse events with TAA nasal spray vs placebo.

Minimum age: 3 Years. Maximum age: 9 Years. Gender(s): Both.

Criteria:

Inclusion criteria:

1. Male subjects [3 years to ≤9 years + 0 days old] at Visit 1 and no older than [9 years + 120 days] at Visit 3; and, female subjects [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 would be permitted under certain circumstances to enable scheduling of Visits 1 and 3

2. At least a one year history of PAR as assessed and documented by the investigator (with or without seasonal allergic rhinitis [SAR])

3. Positive skin test (prick or intradermal) to a perennial allergen that is present in the subject's environment. A skin test is considered positive if the wheal produced by the allergen is equal to or greater than that caused by positive control (histamine) or is at least 3 mm (prick test) or 7 mm (intradermal test) greater than the wheal of negative control (saline). If a skin test cannot be performed, the radioallergosorbent test (RAST) will be used as an alternative. Documented historical skin testing or RAST performed during the past year will be acceptable

4. Height within the 3rd and 97th percentiles at screening (Visit 1), Visit 2, and at randomization (Visit 3)

5. Symptomatic (daily AM instantaneous total nasal symptom score is ≥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 will be completed with the help of a parent/guardian/caregiver

6. Written informed consent and ability of parent or legal guardian of the subject to give a written informed consent before any study related procedures. Subjects 7 years of age and older must provide a signed assent form

7. Subjects must be toilet-trained

Exclusion criteria:

1. Gross nasal anatomical deformities including large polyposis and marked deviated septum

2. History of or current cataract or glaucoma

3. History of hypersensitivity to the corticosteroids or to any excipient of the investigational product

4. Subject is the investigator or any subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol

5. Height, weight, or body mass index (BMI)-for-age below the 3rd or above the 97th percentile at Visits 1, 2, or 3

6. Treatment with systemic corticosteroids (oral, intravenous, intramuscular, or intra-articular) within 3 months prior to Visit 1

7. Treatment with systemic corticosteroids for >2 courses received up to 1 year before Visit 1 is exclusionary. Up to 2 courses of systemic corticosteroids each course not exceeding 14 days up to 1 year before Visit 1 is allowed.

8. Treatment with inhaled, intranasal, or high potency topical corticosteroid exposure within 6 weeks prior to Visit 1. Mild asthma will be well-controlled and without the use of inhaled corticosteroids within 6 weeks before screening (Visit 1).

9. Immunotherapy, except stable (≥1 month) maintenance schedule before Visit 1.

10. Treatment with any substance before Visit 1 that may affect 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

11. 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).

12. Bone age as assessed by xray of the left hand and wrist that is outside +/- 1. 5 years of subjects chronological age at Visit 2. Right hand and wrist will be radiographed in the event of bone injury to the left hand or wrist.

13. Unresolved upper respiratory tract infection, sinus infection or nasal candidiasis (i. e., symptomatic or under treatment)within the last 2 weeks before Visit 3.

14. Subjects or parent/guardian/caregiver unable to demonstrate correct administration of the investigational product at Visit 1.

15. Concomitant disease other than PAR which could interfere with the study procedures or outcomes as determined by the investigator.

16. History of hospitalization due to asthma within 1 year before screening (Visit 1).

17. Abnormal 24-hour urinary free cortisol level assessed at screening (Visit 2).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Public Registry USMA, Email: PublicRegistryUSMA@sanofi-aventis.com

Sanofi-aventis Administrative Office, Bridgewater, New Jersey, United States; Recruiting

Starting date: July 2007
Ending date: November 2011
Last updated: September 30, 2009