NCT00355771

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

Placebo Controlled Pilot Study on the Efficacy of Levocetirizine 5 mg in Reducing Symptoms, Airway Resistance, and Sleep Impairment in Patients With Persistent Allergic Rhinitis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Institut für Atemwegsforschung GmbH · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Levocetirizine 5 mg is well established as the treatment of seasonal and perennial rhinoconjunctivitis. This study has been designed, to investigate its efficacy in patients suffering from persistent allergic rhinitis as defined by the ARIA (Allergic Rhinitis and its Impact on Asthma) working group of the WHO. The study is divided in an 8 ± 2 day screening and a 56 ± 3 day treatment phase. During both periods patients keep a diary reporting on the severity of their nasal and ocular complaints, the use of rescue medication (cromoglycate eye drops and nasal spray), other concomitant medication and adverse events. They apply a 0 to 3 point score (0 = no, 1= mild, 2 = moderate, 3 = severe symptoms) to rate nasal obstruction, rhinorrhea, nasal itching, sneezing and ocular symptoms in regard to their experience during the preceding 24 hours. During the treatment period they additionally report the time of intake of study medication and their assessments of their nasal peak inspiratory flow (NPIF). NPIF is measured every evening before symptom scoring and additionally before each intake of rescue nasal spray. A device similar to the peak flow meters employed for monitoring bronchial asthma is used. Before the treatment period in its middle and at its end patients undergo a polysomnography. Furthermore 2 weeks after the start of treatment and at its end patients and investigators employ a 5-step scale (1 = very good, 2 = good, 3 = moderate, 4 = poor, 5= not at all effective) to assess the efficacy of the study medication. Efficacy is to be established by comparison of a levocetirizine and a placebo treated group.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	Levocetirizine	Intake of 1 tablet of Levocetirizine 5mg OD for 8 weeks
DRUG	Placebo	1 tablet OD in the morning for 8 weeks

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-11-01
• Completion: 2007-11-01
• First posted: 2006-07-25
• Last updated: 2008-01-15

Locations

1 site across 1 country: China