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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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
Are there results?: Yes, posted in the registrySummary in the doctors' view

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.

Italy1 site

Study site
Genova

Other trials in Italy

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 groups in NCT00160680
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.

1 Mar 20051 Jun 2006

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic

All Rhinitis, Allergic, Perennial trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00160680
Acronym / sponsor ID: A00392
Conditions: Rhinitis, Allergic, Perennial
Keywords: Persistent Allergic Rhinitis, HDM, Parietaria, sneezing, rhinorrhea, ocular pruritus, Rhinasthma, inflammatory cells
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: UCB S.A. - Pharma SectorIndustry (pharma, biotech, devices)
Study start: 1 Mar 2005 (actual)
Primary completion: 1 Jun 2006 (actual)
Study completion: 1 Jun 2006 (actual)
First posted: 12 Sep 2005 (estimated)
Results: Posted 22 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Continuous Treatment	Experimental	Drug: Levocetirizine5 mg of Levocetirizine (LCTZ) was taken orally once a day.
On Demand Treatment	Experimental	Drug: Levocetirizine5 mg of Levocetirizine (LCTZ) was taken whenever needed.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LevocetirizineAlso: Xyzal* Pharmaceutical form: Tablet * Concentration: 5 mg * Route of administration: Oral use	Drug	Continuous Treatment, On Demand Treatment

Primary outcome

Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period
Time frame: During the treatment period until week 24
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.

13 secondary outcomes

Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period
Time frame: During month 1 of the 6 months treatment period
Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period
Time frame: During month 2 of the 6 months treatment period
Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period
Time frame: During month 3 of the 6 months treatment period
Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period
Time frame: During month 4 of the 6 months treatment period
Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period
Time frame: During month 5 of the 6 months treatment period
Mean Monthly Total 4 Symptom Score (T4SS) for Month 6 of the Treatment Period
Time frame: During month 6 of the 6 months treatment period
Mean Weekly Individual Symptoms Scores During the Treatment Period
Time frame: During the treatment period until week 24
Mean Monthly Individual Symptoms Scores During Month 1 of the Treatment Period
Time frame: During month 1 of the 6 months treatment period
Mean Monthly Individual Symptoms Scores During Month 2 of the Treatment Period
Time frame: During month 2 of the 6 months treatment period
Mean Monthly Individual Symptoms Scores During Month 3 of the Treatment Period
Time frame: During month 3 of the 6 months treatment period
Mean Monthly Individual Symptoms Scores During Month 4 of the Treatment Period
Time frame: During month 4 of the 6 months treatment period
Mean Monthly Individual Symptoms Scores During Month 5 of the Treatment Period
Time frame: During month 5 of the 6 months treatment period
Mean Monthly Individual Symptoms Scores During Month 6 of the Treatment Period
Time frame: During month 6 of the 6 months treatment period

Results and safety

Results posted to the registry on 22 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Continuous Treatment (CT)	31	22
On Demand Treatment (ODT)	31	18

Primary outcome: Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period

Time frame: During the treatment period until week 24. Least squares mean (Standard Error). Unit: units on a scale

Measure	Continuous Treatment (CT) n = 29	On Demand Treatment (ODT) n = 29
Value	2.89 (0.43)	3.15 (0.44)

Continuous Treatment (CT) vs On Demand Treatment (ODT): Mean Difference (Final Values): 0.27 (95% CI -0.96 to 1.50), p =0.667, ANCOVA

Population analysed: Only patients with a valid mean weekly T4SS during the treatment period were included in the analysis.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from Visit 2 (Week 0) until Visit 9 (Week 24).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Continuous Treatment (SS)	0 of 30 (0%)	4 of 30 (13.3%)	0 of 30
On Demand Treatment (SS)	0 of 32 (0%)	10 of 32 (31.3%)	0 of 32

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Rhinitis, Allergic, Perennial

Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levocetirizine in people with Rhinitis, Allergic, Perennial, run by UCB S.A. - Pharma Sector at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Weekly Total 4 Symptom Score (T4SS) During the Treatment Period (time frame: During the treatment period until week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00160680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.