Clinical trial NCT00160680: ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)
Official title: A Pilot, Open, Monocenter, Randomized Two Parallel Groups, Clinical Efficacy Trial: Comparison Continuous Versus on Demand Regimen of Treatment With Levocetirizine 5 mg Oral Tablets, Once a Day, in Adults Suffering From Persistent Allergic Rhinitis (PER) Over 6 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rhinitis, Allergic, Perennial
Keywords: Persistent Allergic Rhinitis
HDM
Parietaria
sneezing
rhinorrhea
ocular pruritus
Rhinasthma
inflammatory cells
ICAM-1
ATAREAL
Xyzal
Levocetirizine
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
timeFrame: During the treatment period until week 24
Secondary outcomes:
measure: Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period
timeFrame: During month 1 of the 6 months treatment period
measure: Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period
timeFrame: During month 2 of the 6 months treatment period
measure: Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period
timeFrame: During month 3 of the 6 months treatment period
measure: Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period
timeFrame: During month 4 of the 6 months treatment period
measure: Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period
timeFrame: During month 5 of the 6 months treatment period
measure: Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period
timeFrame: During month 6 of the 6 months treatment period
measure: Mean Weekly Individual Symptoms Scores During the Treatment Period
timeFrame: During the treatment period until week 24
measure: Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
timeFrame: During month 1 of the 6 months treatment period
measure: Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
timeFrame: During month 2 of the 6 months treatment period
measure: Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
timeFrame: During month 3 of the 6 months treatment period
measure: Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
timeFrame: During month 4 of the 6 months treatment period
measure: Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
timeFrame: During month 5 of the 6 months treatment period
measure: Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
timeFrame: During month 6 of the 6 months treatment period
Other outcomes:
Locations:
city: Genova
country: Italy
Study officials:
References: