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

NCT01154153 | Completed Phase 4 Results

• 1 other identifier: TRICA_L_04286
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 8

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 measured by serum cortisol AUC(0-24 hr) in children (\>=2 to \<12 years old) with allergic rhinitis (AR).

Conditions

Rhinitis, Allergic, Perennial and/or Seasonal

Outcome Measures

Primary Outcomes (1)

• Ratio of Serum Cortisol Area Under Curve [AUC(0-24 hr)] at the End of Treatment to Baseline

  Blood samples were collected over a 24-hour period (at 0, 2, 4, 8, 12, 20, and 24 hours), with 0 hour being between 8:00AM to 9:00AM, immediately prior to investigational product (IP) administration. AUC (0-24hr) was calculated using the trapezoid rule, and was normalized by dividing the AUC(0-24 hr) by the actual sample collection interval between 0-hour and 24-hour blood draw times. Ratio in Serum Cortisol AUC(0-24 hr) = (Serum Cortisol AUC\[0-24 hr\] at 6 weeks postrandomization)/(Serum Cortisol AUC\[0-24 hr\] at 1-3 days prerandomization). Log transformation was used for the analysis.

  1-3 days prerandomization and 6 weeks postrandomization

Secondary Outcomes (5)

• Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)

  From 8-24 days prerandomization up to 6 weeks postrandomization

• Number of Participants by Relief Level as Evaluated by the Physician

  At end of study (43-50 days after randomization)

• Number of Participants by Relief Level as Evaluated by the Participant

  At end of study (43-50 days after randomization)

• Number of Participants Using Rescue Medication

  From 8 to 24 days prerandomization and randomization to end of study (43-50 days postrandomization)

• The Percent of Days of Rescue Medication Use During the Double-blind Treatment Phase

  From randomization to 43-50 days postrandomization

Study Arms (2)

Placebo

PLACEBO COMPARATOR

* 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.

Drug: Placebo nasal spray; Drug: Claritin® Syrup

TAA-AQ

EXPERIMENTAL

* 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.

Drug: Placebo nasal spray; Drug: Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ); Drug: Claritin® Syrup

Interventions

Placebo nasal spray DRUG

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

Placebo; TAA-AQ

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

TAA-AQ

Claritin® Syrup 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.

Placebo; TAA-AQ

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (8)

Investigational Site Number 840003

Cypress, California, 90630, United States

Location

Investigational Site Number 840006

Stockbridge, Georgia, 30281, United States

Location

Investigational Site Number 840007

North Dartmouth, Massachusetts, 02747, United States

Location

Investigational Site Number 840010

Plymouth, Minnesota, 55441, United States

Location

Investigational Site Number 840001

Omaha, Nebraska, 68144, United States

Location

Investigational Site Number 840008

Raleigh, North Carolina, 27607, United States

Location

Investigational Site Number 840002

Spartanburg, South Carolina, 29307, United States

Location

Investigational Site Number 840005

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Georges G, Kim KT, Ratner P, Segall N, Qiu C. Effect of intranasal triamcinolone acetonide on basal hypothalamic-pituitary-adrenal axis function in children with allergic rhinitis. Allergy Asthma Proc. 2014 Mar-Apr;35(2):163-70. doi: 10.2500/aap.2014.35.3728.

  PMID: 24717794 DERIVED

MeSH Terms

Conditions

Rhinitis

Interventions

Nasal Sprays; Triamcinolone

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Trial Transparency Team
• Organization: sanofi-aventis

Contact-US@sanofi.com

Study Officials

• Medical Affairs

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 30, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 26, 2012
• Results First Posted: October 28, 2011

Record last verified: 2012-06

Locations

US (8)