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ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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