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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2010-10-31

Brief Summary

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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).

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Detailed Description

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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, \>=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.

Conditions

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Rhinitis, Allergic, Perennial and/or Seasonal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

* placebo during the screening phase and
* placebo during the treatment phase.

All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.

Group Type PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type DRUG

1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase.

Placebo nasal spray

Intervention Type DRUG

Treatment assignment was randomized with stratification by sex and age group (\>=2 to \<6, \>=6 to \<12 years old).

* For children who were \>=2 to \<6 years old, 1 spray/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase.
* For children who were \>= 6 yrs to \<12 years old, either 1 spray/nostril or 2 sprays/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase.

Claritin® Syrup

Intervention Type DRUG

Children's Claritin® Syrup \[5 mg of loratadine per 5 mL\] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis, according to the Food and Drug Administration-approved manufacturer's label.

TAA-AQ

* placebo during the screening phase and
* TAA-AQ (Nasacort AQ) during the treatment phase.

All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.

Group Type EXPERIMENTAL

Placebo nasal spray

Intervention Type DRUG

1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase.

Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ)

Intervention Type DRUG

Treatment assignment was randomized with stratification by sex and age group (\>=2 to \<6, \>=6 to \<12 years old).

* For children who were \>=2 to \<6 years old, 1 spray/nostril (110 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase.
* For children who were \>=6 yrs to \<12 years old, either 1 spray/nostril (110 µg TAA-AQ) or 2 sprays/nostril (220 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase.

Claritin® Syrup

Intervention Type DRUG

Children's Claritin® Syrup \[5 mg of loratadine per 5 mL\] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis, according to the Food and Drug Administration-approved manufacturer's label.

Interventions

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Placebo nasal spray

1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase.

Intervention Type DRUG

Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ)

Treatment assignment was randomized with stratification by sex and age group (\>=2 to \<6, \>=6 to \<12 years old).

* For children who were \>=2 to \<6 years old, 1 spray/nostril (110 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase.
* For children who were \>=6 yrs to \<12 years old, either 1 spray/nostril (110 µg TAA-AQ) or 2 sprays/nostril (220 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase.

Intervention Type DRUG

Placebo nasal spray

Treatment assignment was randomized with stratification by sex and age group (\>=2 to \<6, \>=6 to \<12 years old).

* For children who were \>=2 to \<6 years old, 1 spray/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase.
* For children who were \>= 6 yrs to \<12 years old, either 1 spray/nostril or 2 sprays/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase.

Intervention Type DRUG

Claritin® Syrup

Children's Claritin® Syrup \[5 mg of loratadine per 5 mL\] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis, according to the Food and Drug Administration-approved manufacturer's label.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No