Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Allergic Rhinitis

NCT00439712 | Completed Phase 4

• 1 other identifier: Levo-6-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to show that in patients suffering from perennial allergic rhinitis levocetirizine 5 mg OD relieves nasal obstruction. Furthermore the study is to investigate how relevant for these patients their nasal obstruction and the effect of levocetirizine on their nasal obstruction are.

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Average morning nasal obstruction score calculated from diary assessments during treatment.

  4 week treatment period

Secondary Outcomes (7)

• average morning and average evening single symptom score calculated from diary assessments during treatment period (with exception of the primary endpoint)

  4 week treatment period

• average of the daily mean single symptom score (mean of morning and evening assessment) calculated with respect to diary assessments during treatment period

  4 week treatment period

• average morning, evening and total T5SS calculated with respect to the treatment period

  4 week treatment period

• average use of rescue medication (number of applications) during the treatment period

  4 week treatment period

• differences between the preceding parameters and the respective averages calculated in regard to the follow-up period

  4 week treatment and 2 week follow-up period

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

Drug: Levocetirizine

Treatment Group 2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Levocetirizine DRUG

1 tablet of Levocetirizine 5 mg OD in the morning for 29+/-4 days

Treatment Group 1

Placebo DRUG

1 placebo tablet OD in the morning for 29+/-4 days

Treatment Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 to 65 years (inclusively).
• Ability to understand nature, scope and possible consequences of the study.
• Capability and willingness to comply with the requirements of the protocol.
• Written informed consent was granted after in depth written and oral information on all relevant aspects of the study.
• Adequate contraception in case of females of child bearing potential (i.e. hormonal contraception, IUD, double barrier method, monogamous sexual relation with an monogamous partner, sexual inactivity).
• At least 2 year history of perennial allergic rhinitis with pronounced symptoms.
• Sensitization to D. farinae or D. pteronyssinus proved by a prick test (wheal diameter ≥ 3 mm) or measurement of specific IgE (at least RAST class 2) at most one year ago.
• On visit 2: Sum of the morning nasal obstruction scores documented in the screening diary is at least 40% of the maximal sum the patient could have attained.

You may not qualify if:

• Exposure to another investigational agent within the last three months.
• Pregnancy or nursing.
• Severe diseases and diseases, conditions or findings which might interfere with the study results, deteriorate due to study participation or require impermissible medication. In particular this includes
• restricted liver or kidney function or respectively creatinine clearance below 50 ml/min, the clearance being estimated according to the formula by Cockcroft/Gault from serum creatinine assessed on visit 1,
• nasal polyps, severe deviations of the nasal septum, and any other considerable impairments of nasal patency,
• an ear, nose or throat infection during the last 2 weeks or any other but allergic form of rhinitis,
• asthma requiring any other treatment than short acting β-agonists on demand,
• atopic dermatitis with considerable probability to require corticosteroid treatment.
• Intake of impermissible medication or non observance of the designated washout periods.
• History of malignancy within the last 5 years.
• Drug or alcohol abuse.
• Intention to donate blood during the study period.
• Intolerance to one of the components of the trial medication.

Sponsors & Collaborators

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

Study Sites (1)

Institut für Atemwegsforschung GmbH

Düsseldorf, North Rhine-Westphalia, 404597, Germany

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Interventions

levocetirizine

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Claus Bachert, MD, PhD

  Institut für Atemwegsforschung GmbH

  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: February 22, 2007
• First Posted: February 26, 2007
• Study Start: February 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: January 15, 2008

Record last verified: 2008-01

Locations

DE (1)