Rhinitis, Allergic, PerennialPhase 4NCT00160680
ATAREAL (Antihistamine Treatment for Allergic Rhinitis in Real Life)
A Phase 4 study testing Levocetirizine in people with Rhinitis, Allergic, Perennial, run by UCB S.A. - Pharma Sector at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Allergic, Perennial
- What is being tested?
- Levocetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2005to 1 Jun 2006
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
Comparison of clinical efficacy and safety of levocetirizine in PER continuous versus on demand, measured by evolution of individual symptom scores during 6 months.
- Conditions
- Rhinitis, Allergic, Perennial
- Being tested
- Levocetirizine
- Keywords
- Persistent Allergic Rhinitis, HDM, Parietaria, sneezing, rhinorrhea, ocular pruritus, Rhinasthma, inflammatory cells, ICAM-1, ATAREAL, Xyzal, Levocetirizine
- Medical subject headings
- Rhinitis, Allergic, Perennial, Sneezing, Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
Also called Xyzal
- Pharmaceutical form: Tablet
- Concentration: 5 mg
- Route of administration: Oral use
| Study group | Role | What they receive |
|---|---|---|
| Continuous Treatment | Experimental | 5 mg of Levocetirizine (LCTZ) was taken orally once a day. Receives: Drug: Levocetirizine |
| On Demand Treatment | Experimental | 5 mg of Levocetirizine (LCTZ) was taken whenever needed. Receives: Drug: Levocetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Measured: During the treatment period until week 24
Secondary outcomes (13)
Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Measured: During month 1 of the 6 months treatment period
Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Measured: During month 2 of the 6 months treatment period
Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Measured: During month 3 of the 6 months treatment period
Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Measured: During month 4 of the 6 months treatment period
Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Measured: During month 5 of the 6 months treatment period
Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period
The T4SS is the sum of the symptom scores for sneezing, rhinorrhea, nasal pruritus and ocular pruritus. Each of the symptoms is rated retrospectively over the past 24 hours using a 4-point 0 to 3 scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total T4SS is the sum of the idividual scores and ranges from 0-12. Increasing values are associated with increasing severity of disease.
Measured: During month 6 of the 6 months treatment period
Mean Weekly Individual Symptoms Scores During the Treatment Period
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.
The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Measured: During the treatment period until week 24
Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.
The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Measured: During month 1 of the 6 months treatment period
Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.
The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Measured: During month 2 of the 6 months treatment period
Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.
The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Measured: During month 3 of the 6 months treatment period
Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.
The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Measured: During month 4 of the 6 months treatment period
Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.
The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Measured: During month 5 of the 6 months treatment period
Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
Individual symptom scores include scores for Sneezing, Rhinorrhea, Nasal Pruritus, Ocular Pruritus, and Nasal Congestion.
The subjects had to evaluate the severity of the symptoms retrospectively over the past 24 hours (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Increasing scores are associated with increasing severity.
Measured: During month 6 of the 6 months treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study start1 Mar 2005
- Primary completion1 Jun 2006
- Study completion1 Jun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rhinitis, Allergic, PerennialStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB S.A. - Pharma Sector
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160680
- Sponsor's protocol ID
- A00392
- Other IDs
- 2004-003858-26, 2004
- Status last verified
- Aug 2023
- First submitted
- 8 Sep 2005
- Last updated
- 31 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov