ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)

NCT ID: NCT00160680

Last Updated: 2023-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-01

Study Completion Date

2006-06-01

Brief Summary

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

Detailed Description

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Conditions

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Rhinitis, Allergic, Perennial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Continuous Treatment

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

Group Type EXPERIMENTAL

Levocetirizine

Intervention Type DRUG

* Pharmaceutical form: Tablet
* Concentration: 5 mg
* Route of administration: Oral use

On Demand Treatment

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

Group Type EXPERIMENTAL

Levocetirizine

Intervention Type DRUG

* Pharmaceutical form: Tablet
* Concentration: 5 mg
* Route of administration: Oral use

Interventions

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Levocetirizine

* Pharmaceutical form: Tablet
* Concentration: 5 mg
* Route of administration: Oral use

Intervention Type DRUG

Other Intervention Names

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Xyzal

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB S.A. - Pharma Sector

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Genova, , Italy

Site Status

Countries

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Italy

Related Links

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Other Identifiers

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2004-003858-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

A00392

Identifier Type: -

Identifier Source: org_study_id

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