Levocetirizine 5 mg: Reduction of Symptoms, Airway Resistance and Sleep Impairment in Persistent Allergic Rhinitis

NCT00355771 | Completed Phase 4

• 1 other identifier: 1-1-2005
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate, whether levocetirizine 5 mg relieves nasal and ocular symptoms of persistent allergic rhinitis and reduces increased airway resistance and sleep impairment due to this condition.

Conditions

Allergic Rhinitis

Keywords

allergic rhinitis; histamine antagonist; sleep disorder

Outcome Measures

Primary Outcomes (1)

• Average T5SS calculated with respect to the 8 week treatment period. T5SS is the daily sum of 4-step symptom scores, which patients use to report the severity of five symptoms of allergic rhinoconjunctivitis in their diaries.

  8 week treatment period

Secondary Outcomes (5)

• Average of the individual symptom scores

  8 week treatment period

• average daily NPIF

  8 week treatment period

• average use of rescue medication

  8 week treatment period

• sleep quality parameters assessed by polysomnography

  in the beginning and after 6 to 8 weeks of treatment

• global valuation of the efficacy

  after 4 and 8 weeks of treatment

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

Drug: Levocetirizine

Treatment Group 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Levocetirizine DRUG

Intake of 1 tablet of Levocetirizine 5mg OD for 8 weeks

Treatment Group 1

Placebo DRUG

1 tablet OD in the morning for 8 weeks

Treatment Group 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who demonstrate their willingness to participate in the study and to comply with its procedures by signing a written informed consent.
• Subjects aged between 18 and 50 years (inclusively), of either sex and any race.
• Women of childbearing potential have to use an acceptable method of birth control.
• Subjects have to be able to understand and to adhere to the dosing and visit schedules, and to agree to record symptom scores, NPIF measurements, adverse events, concomitant medications and intake of rescue medication accurately and consistently in a daily diary.
• Subjects have to suffer from symptoms of allergic rhinitis on more than 4 days a week and for more than 4 weeks per year (ARIA criteria).
• History of at least two years of persistent allergic rhinitis (as defined by ARIA criteria).
• T5SS (Total Five Symptom Score, sum of scores evaluating the severity of five symptoms of rhinoconjunctivitis) assessed on visit 1 is \> 8; in particular, nasal obstruction is rated ≥ 2.
• A CAP or prick test obtained within 12 months before visit 1 demonstrating sensitization to one or more allergens which anticipate symptoms of persistent allergic rhinitis on at least 4 days per week during the treatment period.
• On visit 2: Average T5SS calculated from diary reports is \> 8 during the screening period; average rating of nasal obstruction is ≥ 2.

You may not qualify if:

• Women who are pregnant or nursing.
• Subjects who have not observed the designated washout periods for any of the prohibited medications.
• Subjects unable to understand the nature, scope, and possible consequences of the study or being suspected of non-compliance.
• Subjects who have used any investigational product within 30 days prior to enrollment or any investigational antibodies for asthma or allergic rhinitis in the past 90 days.
• History of alcohol or drug abuse.
• Any disease of the upper and lower respiratory tract except for allergic rhinitis during the last 2 weeks before visit 1, 2 and 3; any significant impairment of nasal patency.
• Subjects with current evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune disease; or a tumor or conditions which may interfere with the absorption, distribution, metabolism or excretion of the study medication.
• Any deviation from normal in physical examination and any disease (except for allergic rhinoconjunctivitis), which might deteriorate significantly due to the subject's participation, or require impermissible medication or interfere with study evaluation.
• History of hypersensitivity to the study drug or its excipients.

Sponsors & Collaborators

• Institut für Atemwegsforschung GmbH: lead
• UCB Pharma: collaborator

Study Sites (1)

Department of ORL, West China Hospital, Sichuan Hospital

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Sleep Wake Disorders

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Claus Bachert, MD, PhD

  Institut für Atemwegsforschung

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 25, 2006
• Study Start: June 1, 2006
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: January 15, 2008

Record last verified: 2008-01

Locations

CN (1)