Phase 4 N=62 Randomized Treatment

ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

Rhinitis, Allergic, Perennial

Bottom Line

View on ClinicalTrials.gov: NCT00160680 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2019

Primary outcome: Primary: Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period — 2.89; 3.15 units on a scale — p==0.667

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Levocetirizine (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: UCB S.A. - Pharma Sector
Primary completion: Jun 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period	2.89; 3.15	=0.667
SECONDARY Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period	4.55; 3.83	—
SECONDARY Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period	4.04; 3.14	—
SECONDARY Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period	2.98; 2.58	—
SECONDARY Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period	2.47; 2.67	—
SECONDARY Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period	1.74; 3.31	—
SECONDARY Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period	2.19; 3.64	—
SECONDARY Mean Weekly Individual Symptoms Scores During the Treatment Period	0.82; 0.94; 0.80; 0.80; 0.71; 0.74	—
SECONDARY Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period	1.31; 1.12; 1.33; 0.93; 1.06; 0.97	—
SECONDARY Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period	1.20; 0.87; 1.14; 0.80; 0.98; 0.75	—
SECONDARY Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period	0.82; 0.81; 0.84; 0.66; 0.74; 0.53	—
SECONDARY Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period	0.78; 0.85; 0.69; 0.72; 0.60; 0.59	—
SECONDARY Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period	0.51; 1.00; 0.51; 0.93; 0.44; 0.77	—
SECONDARY Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period	0.61; 1.11; 0.57; 1.00; 0.59; 0.84	—

Summary

Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on demand, measured by evolution of individual symptom scores during 6 months.

Eligibility Criteria

Inclusion Criteria

Clinical history of Persistent allergic Rhinitis (PER) requiring treatment known at least since 2 years.
Positive skin prick test (wheal > 3 mm larger than the diluent control) or Radio Allergo Sorbent Assay (RAST) (>= 3.5 IU/ml) to House Dust Mite (HDM) and Parietaria (less than 1 year).
Minimum mean Total 4 Symptom Score (T4SS) of 6 over baseline period.

Exclusion Criteria

Subjects currently treated by specific parietaria pollen immunotherapy
Subjects suffering from non-allergic asthma
Chronic use of inhaled steroids and/or long acting β2 agonists; and/or corticosteroids dependent asthma (severe asthma)
Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00160680). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.