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| Sponsor: | Institut für Atemwegsforschung GmbH |
|---|---|
| Collaborator: |
UCB, Inc. |
| Information provided by: | Institut für Atemwegsforschung GmbH |
| ClinicalTrials.gov Identifier: | NCT00439712 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Perennial Allergic Rhinitis |
Drug: Levocetirizine Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy of Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Rhinitis |
| Enrollment: | 60 |
| Study Start Date: | February 2007 |
| Study Completion Date: | May 2007 |
| Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Treatment Group 1: Experimental |
Drug: Levocetirizine
1 tablet of Levocetirizine 5 mg OD in the morning for 29+/-4 days
|
| Treatment Group 2: Placebo Comparator |
Drug: Placebo
1 placebo tablet OD in the morning for 29+/-4 days
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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
Contacts and Locations| Germany, Nordrhein-Westfalen | |
| Institut für Atemwegsforschung GmbH | |
| Düsseldorf, Nordrhein-Westfalen, Germany, 404597 | |
| Principal Investigator: | Claus Bachert, MD, PhD | Institut für Atemwegsforschung GmbH |
More Information
| Responsible Party: | Institut für Atemwegsforschung GmbH ( Claus Bachert MD PhD ) |
| Study ID Numbers: | Levo-6-06 |
| Study First Received: | February 22, 2007 |
| Last Updated: | January 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00439712 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Neurotransmitter Agents Nasal Obstruction Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Rhinitis Hypersensitivity Respiratory Insufficiency Respiratory Tract Infections Respiratory Tract Diseases Rhinitis, Allergic, Perennial Levocetirizine Therapeutic Uses Otorhinolaryngologic Diseases |
Immune System Diseases Respiration Disorders Histamine Agents Anti-Allergic Agents Cetirizine Nose Diseases Pharmacologic Actions Histamine Antagonists Hypersensitivity, Immediate Histamine H1 Antagonists Airway Obstruction Histamine H1 Antagonists, Non-Sedating Respiratory Hypersensitivity |