- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00439712
Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Allergic Rhinitis
Efficacy of Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Rhinitis
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Nordrhein-Westfalen
-
Düsseldorf, Nordrhein-Westfalen, Germany, 404597
- Institut für Atemwegsforschung GmbH
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment Group 1
|
1 tablet of Levocetirizine 5 mg OD in the morning for 29+/-4 days
|
Placebo Comparator: Treatment Group 2
|
1 placebo tablet OD in the morning for 29+/-4 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Average morning nasal obstruction score calculated from diary assessments during treatment.
Time Frame: 4 week treatment period
|
4 week treatment period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
average morning and average evening single symptom score calculated from diary assessments during treatment period (with exception of the primary endpoint)
Time Frame: 4 week treatment period
|
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
Time Frame: 4 week treatment period
|
4 week treatment period
|
average morning, evening and total T5SS calculated with respect to the treatment period
Time Frame: 4 week treatment period
|
4 week treatment period
|
average use of rescue medication (number of applications) during the treatment period
Time Frame: 4 week treatment period
|
4 week treatment period
|
differences between the preceding parameters and the respective averages calculated in regard to the follow-up period
Time Frame: 4 week treatment and 2 week follow-up period
|
4 week treatment and 2 week follow-up period
|
results and changes in results of questionnaire 1
Time Frame: assessed on visits during the 7 week study period
|
assessed on visits during the 7 week study period
|
results of questionnaires 2, 3 and 4
Time Frame: assessed on visits during the 4 week treatment and the 2 week follow-up period
|
assessed on visits during the 4 week treatment and the 2 week follow-up period
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Claus Bachert, MD, PhD, Institut für Atemwegsforschung GmbH
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Respiration Disorders
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Respiratory Insufficiency
- Airway Obstruction
- Rhinitis
- Rhinitis, Allergic
- Rhinitis, Allergic, Perennial
- Nasal Obstruction
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Histamine H1 Antagonists, Non-Sedating
- Levocetirizine
Other Study ID Numbers
- Levo-6-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Perennial Allergic Rhinitis
-
UCB PharmaCompletedRhinitis | Allergic | Perennial
-
United Allergy ServicesCompletedPerennial Allergic Rhinitis With Seasonal VariationUnited States
-
Eli Lilly and CompanyNot yet recruitingPerennial Allergic Rhinitis (PAR)United States
-
UCB PharmaCompletedRhinitis | Allergic | Perennial
-
Teva Branded Pharmaceutical Products R&D, Inc.United BioSource, LLCCompletedEffectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis (BALANCE)Perennial Allergic Rhinitis (PAR)United States
-
SanofiCompleted
-
Organon and CoCompletedPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis
-
Universitaire Ziekenhuizen KU LeuvenAZ Sint-Jan AVRecruitingPerennial Allergic Rhinitis | Seasonal Allergic Rhinitis | Local Allergic RhinitisBelgium
-
Humanis Saglık Anonim SirketiCompletedPerennial Allergic Rhinitis | Seasonal Allergic RhinitisIndia
Clinical Trials on Levocetirizine
-
Hospices Civils de LyonCompletedChronic Spontaneous Urticaria
-
UCB PharmaCompleted
-
Brian J LipworthCompletedAllergic RhinitisUnited Kingdom
-
GlaxoSmithKlineZensei Pharmaceutical Co., Ltd.Completed
-
IPCA Laboratories Ltd.Completed
-
HK inno.N CorporationUnknownPerennial Allergic Rhinitis
-
UCB PharmaCompleted
-
University Hospital, GrenobleRecruiting
-
Dr. Reddy's Laboratories LimitedCompleted