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

Participants meeting the following eligibility criteria were enrolled.

Inclusion criteria

• Male participants [3 years to = 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.