ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

UCB

Status and phase: Completed; Phase 4

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Levocetirizine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00160680

A00392

2004-003858-26 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Continuous Treatment

Experimental group

Description:

5 mg of Levocetirizine (LCTZ) was taken orally once a day.

Treatment:

Drug: Levocetirizine

On Demand Treatment

Experimental group

Description:

5 mg of Levocetirizine (LCTZ) was taken whenever needed.

Treatment:

Drug: Levocetirizine