NCT00160680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Mar 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
12.7 years until next milestone

Results Posted

Study results publicly available

January 22, 2019

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

September 8, 2005

Results QC Date

October 10, 2017

Last Update Submit

August 29, 2023

Conditions

Rhinitis, Allergic, Perennial

Keywords

Persistent Allergic RhinitisHDMParietariasneezingrhinorrheaocular pruritusRhinasthmainflammatory cellsICAM-1ATAREALXyzalLevocetirizine

Outcome Measures

Primary Outcomes (1)

  • 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.

    During the treatment period until week 24

Secondary Outcomes (13)

  • Mean Monthly Total 4 Symptom Score (T4SS) for Month 1 of the Treatment Period

    During month 1 of the 6 months treatment period

  • Mean Monthly Total 4 Symptom Score (T4SS) for Month 2 of the Treatment Period

    During month 2 of the 6 months treatment period

  • Mean Monthly Total 4 Symptom Score (T4SS) for Month 3 of the Treatment Period

    During month 3 of the 6 months treatment period

  • Mean Monthly Total 4 Symptom Score (T4SS) for Month 4 of the Treatment Period

    During month 4 of the 6 months treatment period

  • Mean Monthly Total 4 Symptom Score (T4SS) for Month 5 of the Treatment Period

    During month 5 of the 6 months treatment period

  • +8 more secondary outcomes

Study Arms (2)

Continuous Treatment

EXPERIMENTAL

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

Drug: Levocetirizine

On Demand Treatment

EXPERIMENTAL

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

Drug: Levocetirizine

Interventions

LevocetirizineDRUG

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

Also known as: Xyzal
Continuous TreatmentOn Demand Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Genova, Italy

Location

Related Links

MeSH Terms

Conditions

Rhinitis, Allergic, PerennialSneezingRhinorrhea

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
UCB
Organization
Cares
UCBCares@ucb.com
+1844 599

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

March 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

August 31, 2023

Results First Posted

January 22, 2019

Record last verified: 2023-08

Locations

IT(1)