Status:
COMPLETED
Study of Triamcinolone Acetonide on the Growth Velocity of Children, Ages 3 to 9, With Perennial Allergic Rhinitis (PAR)
Lead Sponsor:
Sanofi
Conditions:
Rhinitis, Allergic, Perennial
Eligibility:
All Genders
3-9 years
Phase:
PHASE4
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 ...
Detailed Description
The study consisted of: * a 4- to 6-month screening/baseline period * a 12-month (up to Day 360+/-5 days) double-blind treatment period starting on Day 1 * a 2-month follow-up period (up to Day 420+/...
Eligibility Criteria
Inclusion
- Participants meeting the following eligibility criteria were enrolled.
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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 systemic corticosteroids for \>2 courses received up to 1 year before Visit 1 was exclusionary. Up to 2 courses of systemic corticosteroids each course not exceeding 14 days up to 1 year before Visit 1 was allowed.
- 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).
- Abnormal 24-hour urinary free cortisol level assessed at screening (Visit 2).
- The above information was not intended to contain all considerations relevant to potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT00449072
Start Date
March 1 2007
End Date
October 1 2011
Last Update
August 10 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807