Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis

Completed · Phase 4 · Has a placebo group

Conditions studied: Rhinitis, Allergic, Perennial and/or Seasonal

In brief

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).

Key facts

Study ID

NCT01154153

Run by

Sanofi

People needed

140

Starts

2010-06-01

Expected to finish

2010-10-01

Last updated by the study team

2012-06-26

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840003 — Cypress, California, United States
• Investigational Site Number 840006 — Stockbridge, Georgia, United States
• Investigational Site Number 840007 — North Dartmouth, Massachusetts, United States
• Investigational Site Number 840010 — Plymouth, Minnesota, United States
• Investigational Site Number 840001 — Omaha, Nebraska, United States
• Investigational Site Number 840008 — Raleigh, North Carolina, United States
• Investigational Site Number 840002 — Spartanburg, South Carolina, United States
• Investigational Site Number 840005 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.