nasacort aq hypothalamic-pituitary-adrenal (hpa) axis study in children with allergic rhinitis

Conditions: Rhinitis, Allergic, Perennial and/or Seasonal

Summary: the primary objective was to evaluate the effect of a 6-week treatment with taa-aq (110 μg) and taa-aq (220 μg) once daily (qd) versus placebo on hypothalamic-pituitary-adrenal (hpa) axis function as measured by serum cortisol auc(0-24 hr) in children (\>=2 to \<12 years old) with allergic rhinitis (ar).

the study consisted of a run-in single-blind screening phase (prerandomization) followed by an approximately 6-week double-blind treatment phase (postrandomization). total study duration per participant lasted from 7.5 to 13 weeks and consisted of: * screening and single-blind phases (these 2 phases ran concurrently, prerandomization) for 8 to 24 days. during the screening phase participants were given a single-blind placebo nasal spray to enable them to practice their intranasal application technique once daily in the morning (1 actuation/nostril). * randomization to the double-blind treatment phase. treatment assignment was randomized with stratification by sex and age group (\>=2 to \ =6 to \<12 years old). * double-blind treatment phase which lasted at least 42 days and ran up to 47 days. participants were administered either taa-aq nasal spray or placebo nasal spray. * an evaluation at the end of treatment 1-3 days after completion of the double-blind phase.

Eligibility criteria:
participants who met the following criteria were eligible for this study: inclusion criteria: * history of ar documented by the investigator, as follows: * at least a 1-year clinical history (6-month history if the participant was \>= 2 to \< 4 years of age) of perennial allergic rhinitis (par); or a clinical history of seasonal allergic rhinitis (sar) over 2 seasons and * positive skin test (prick or intradermal) to a seasonal or perennial allergen that was present in the participant's environment at time of screening. * written informed consent and ability of parent/legal guardian of the participant to give a written informed consent before any study related procedures. participants \>=7 years of age (or younger according to the governing institutional review board \[irb\]) had to provide a signed assent form exclusion criteria: * concomitant medical condition that might have interfered with the administration of a nasal spray, including anatomical abnormalities of the nose, face (eg, polyposis, markedly deviated septum) * presence of any active, untreated, or clinically significant musculoskeletal, endocrinologic, gastrointestinal, hepatic, respiratory, cardiovascular, or neurological condition that might have interfered with the study * any conditions or treatment that might have affected the hpa axis or the plasma cortisol assay, including but not limited to: * documented disorder involving the hypothalamus, pituitary, or adrenal gland * current use of serotonergic, dopaminergic, adrenergic, cholinergic agonists and antagonists, opiates, immunomodulatory, hormonal drugs, and lipid-lowering agents * 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 corticosteroids within 6 weeks of visit 1 * history of hospitalization due to asthma within 1 year before screening. participants with mild asthma that was well-controlled without the use of inhaled corticosteroids within 6 weeks prior to visit 1 were eligible for the study * any clinically significant (as determined by the investigator) abnormal laboratory test at visit 1 * morning serum cortisol outside the reference range at visit 1 * any of the following missing serum cortisol samples from the visit-2 collection: first sample (before administration of investigational product), 20-hour sample, 24-hour sample, or any 2 consecutive samples * any medical condition where use of corticosteroids might have been contraindicated or could have led to disease exacerbation (eg, glaucoma, cataract, ocular herpes simplex, tuberculosis, growth retardation) * history of hypersensitivity to corticosteroids or to the rescue medication, investigational product, or to any of their excipients * unresolved upper respiratory tract infection, sinus infection, or nasal candidiasis (ie, symptomatic or under treatment) within the last 2 weeks prior to visit 1 and visit 3 * females of childbearing potential not protected by effective contraceptive method of birth control or were unwilling to abstain from sexual activity and/or, were unwilling or unable to test for pregnancy. only female adolescent with onset of menses were to be checked by serum pregnancy test at visit 1 * pregnant female adolescent (who tested positive for pregnancy at visit 1) the above information was not intended to contain all considerations relevant to potential participation in a clinical trial.