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, \>=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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
140
1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase.
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.
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
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.
Time frame: 1-3 days prerandomization and 6 weeks postrandomization
Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)
Every morning, participants rated the severity of symptoms experienced over the previous 24 hours using scale from 0-3, where 0=symptoms absent, 1=mild, 2=moderate, and 3=severe symptoms (interfere with daily living or sleep) for each symptom (nasal congestion, nasal itching, sneezing, and runny nose). The rTNSS was the sum of the individual symptom scores, ranged from 0-12 (where 12 reflected the worst symptoms). Change from baseline in the rTNSS = mean rTNSS (double-blind treatment phase) - mean rTNSS (screening phase).
Time frame: From 8-24 days prerandomization up to 6 weeks postrandomization
Number of Participants by Relief Level as Evaluated by the Physician
Efficacy of treatment was assessed by the physician using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).
Time frame: At end of study (43-50 days after randomization)
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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.
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.
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
Number of Participants by Relief Level as Evaluated by the Participant
Efficacy of treatment was assessed by the participant using a scale from 0-4 for relief levels, where 0 = no relief (symptoms unchanged or worsened than before), 1 = slight relief (symptoms present and only minimally improved), 2 = moderate relief (symptoms are present and may be troublesome, but are noticeably improved), 3 = marked relief (symptoms are greatly improved and although present are scarcely troublesome) and 4 = complete relief (virtually no symptom present).
Time frame: At end of study (43-50 days after randomization)
Number of Participants Using Rescue Medication
The number of participants using the rescue medication (Claritin®) during the single-blind screening phase (the time from 8-24 days before randomization up to the day before randomization) and during the double-blind treatment phase (the time from randomization to end of study).
Time frame: 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
The percent of days of rescue medication used during the double-blind treatment phase was calculated. For participants who did not use any rescue medication, the percentage of days using rescue medication was set to be 0.
Time frame: From randomization to 43-50 days postrandomization