Status:
COMPLETED
Nasacort AQ Hypothalamic-Pituitary-Adrenal (HPA) Axis Study in Children With Allergic Rhinitis
Lead Sponsor:
Sanofi
Conditions:
Rhinitis, Allergic, Perennial and/or Seasonal
Eligibility:
All Genders
2-12 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
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 particip...
Eligibility Criteria
Inclusion
- Participants who met the following criteria were eligible for this study:
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01154153
Start Date
June 1 2010
End Date
October 1 2010
Last Update
June 26 2012
Active Locations (8)
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1
Investigational Site Number 840003
Cypress, California, United States, 90630
2
Investigational Site Number 840006
Stockbridge, Georgia, United States, 30281
3
Investigational Site Number 840007
North Dartmouth, Massachusetts, United States, 02747
4
Investigational Site Number 840010
Plymouth, Minnesota, United States, 55441