Levocetirizine 5 mg: Reduction of Symptoms, Airway Resistance and Sleep Impairment in Persistent Allergic Rhinitis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- 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. [ Time Frame: 8 week treatment period ] [ Designated as safety issue: No ]
- Average of the individual symptom scores [ Time Frame: 8 week treatment period ] [ Designated as safety issue: No ]
- average daily NPIF [ Time Frame: 8 week treatment period ] [ Designated as safety issue: No ]
- average use of rescue medication [ Time Frame: 8 week treatment period ] [ Designated as safety issue: No ]
- sleep quality parameters assessed by polysomnography [ Time Frame: in the beginning and after 6 to 8 weeks of treatment ] [ Designated as safety issue: No ]
- global valuation of the efficacy [ Time Frame: after 4 and 8 weeks of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||November 2007|
|Primary Completion Date:||November 2007 (Final data collection date for primary outcome measure)|
|Experimental: Treatment Group 1||
Intake of 1 tablet of Levocetirizine 5mg OD for 8 weeks
|Placebo Comparator: Treatment Group 2||
1 tablet OD in the morning for 8 weeks
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.
|Department of ORL, West China Hospital, Sichuan Hospital|
|Chengdu, Sichuan, China, 610041|
|Principal Investigator:||Claus Bachert, MD, PhD||Institut für Atemwegsforschung|