Levocetirizine in the Treatment of Nasal Obstruction Due to Perennial Allergic Rhinitis
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Nasal Obstruction
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Levocetirizine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet of Levocetirizine 5 mg OD in the morning for 29+/-4 days; 1 placebo tablet OD in the morning for 29+/-4 days
Intervention MeSH terms: Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment