Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00439712
Status:
COMPLETED
Last Update Posted:
2008-01-15
First Post:
2007-02-22
Brief Title:
Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Allergic Rhinitis
Sponsor:
Institut für Atemwegsforschung GmbH
Organization:
Institut für Atemwegsforschung GmbH
Study Overview
Official Title:
Efficacy of Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Rhinitis
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
The study is performed according to a monocentre double-blind placebo controlled two arm parallel group design It is divided in 3 periods A 7 2 day screening phase when patients are not to treat their perennial allergic rhinitis PAR is followed by a 29 4 day treatment period when patients administer either levocetirizine 5 mg OD or placebo and a 14 2 week post treatment observation period when again medication against PAR is not to be taken However in all study periods patients are provided cromoglicine nasal spray and eye drops which in case of severe complaints they may use as rescue medication
Throughout the study patients keep a diary documenting the severity of their nasal and ocular symptoms of allergy Every morning and every evening they use a 4-point scale 0 no symptom 1 mild 2 moderate 3 severe to rate nasal obstruction rhinorrhea nasal itching sneezing and ocular complaints they experienced during the preceding 12 hours Furthermore they report adverse events and intake of drugs inclusive of rescue and during treatment period study medication
Patients attend 5 visits to the study site On visit 1 medical history and concomitant medication are assessed and patients undergo a physical examination a pregnancy test in case of women of child bearing potential and if necessary a skin prick test Blood is taken to estimate creatinine clearance Inclusion and exclusion criteria are checked and if they do not contradict study continuation patients enter the screening period which ends in the morning of the day visit 2 If on this visit morning diary reports show sufficiently high nasal obstruction scores and study participation still complies with the inclusion and exclusion criteria patients are randomized and start the treatment period taking the first dose at the study site On visit 2 as well as on the following visits adverse events and use of medication are surveyed and compliance is checked Visit 3 4 and 5 are scheduled after one week of treatment between treatment and post treatment observation period and at the end of the study respectively On visit 5 there is a final physical examination and again females of childbearing potential undergo a pregnancy test To assess how relevant for patients nasal obstruction and the effect of the study medication on nasal obstruction are questionnaires are completed on each visit
Throughout the study patients keep a diary documenting the severity of their nasal and ocular symptoms of allergy Every morning and every evening they use a 4-point scale 0 no symptom 1 mild 2 moderate 3 severe to rate nasal obstruction rhinorrhea nasal itching sneezing and ocular complaints they experienced during the preceding 12 hours Furthermore they report adverse events and intake of drugs inclusive of rescue and during treatment period study medication
Patients attend 5 visits to the study site On visit 1 medical history and concomitant medication are assessed and patients undergo a physical examination a pregnancy test in case of women of child bearing potential and if necessary a skin prick test Blood is taken to estimate creatinine clearance Inclusion and exclusion criteria are checked and if they do not contradict study continuation patients enter the screening period which ends in the morning of the day visit 2 If on this visit morning diary reports show sufficiently high nasal obstruction scores and study participation still complies with the inclusion and exclusion criteria patients are randomized and start the treatment period taking the first dose at the study site On visit 2 as well as on the following visits adverse events and use of medication are surveyed and compliance is checked Visit 3 4 and 5 are scheduled after one week of treatment between treatment and post treatment observation period and at the end of the study respectively On visit 5 there is a final physical examination and again females of childbearing potential undergo a pregnancy test To assess how relevant for patients nasal obstruction and the effect of the study medication on nasal obstruction are questionnaires are completed on each visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None