Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives: Allergic Rhinitis (AR) is a global health problem. 10-25% of population worldwide
      is affected by AR. Oral/intranasal H1-antihistamine, decongestants, leukotriene receptor
      antagonists, intranasal corticosteroids are the pillars in the management of AR.Materials and
      methods: Seventy patients with allergic rhinitis participated in a prospective, randomized,
      double-blind, parallel, active controlled, comparative 4 week trial. The patients between age
      group of 18-65 years of either gender having moderate-severe intermittent or mild persistent
      allergic rhinitis were included. The study inclusion criteria required the subjects with
      Total Nasal Symptom Score (TNSS) of 5 or higher. The patients were randomly divided into two
      treatment groups with montelukast-levocetrizine (10 mg and 5 mg) in one group and
      montelukast-fexofenadine (10 mg and 120 mg) in another group. TNSS parameter was the main
      effectiveness parameter.
    

Detailed description: 
      Allergic Rhinitis (AR) is a global health problem. It is the cause of major illness and
      disability worldwide. Estimates indicate that 10-25% of population worldwide is affected by
      AR. The main symptoms of AR include nasal congestion, rhinorrhea, itching, sneezing and
      non-nasal symptoms like burning, itching and watery eyes or itching ears and palate. These
      symptoms can have a considerable toll on patient's quality of life by interfering with
      cognitive and emotional functioning. The estimated annual cost attributable to AR in United
      States ranges from $1.4 billion to nearly $ 6 billion in direct cost annually. Today's
      antiallergic therapy is based on avoidance of the causative allergen, symptomatic
      pharmacotherapy, specific immunotherapy and education. Oral/intranasal H1-antihistaminics,
      decongestants, leukotrienes receptor antagonists, intranasal corticosteroids are the pillars
      in the management of allergic rhinitis. Second generation antihistamines have become
      increasingly popular because of their comparable efficacy and lower incidence of adverse
      effects relative to first generation counterparts. Levocetirizine, a potent second generation
      histamine (H1) receptor antagonist, is effective against persistent allergic rhinitis and
      thus improves quality of life and reduces co-morbidities and societal costs. Fexofenadine, is
      a selective, non sedating, second generation H1 receptor antagonist which have an additional
      impact on the inflammatory mediators. Monteleukast is a highly selective type I receptor
      antagonist of leukotriene D4. The leukotrienes modifiers have both anti-inflammatory and
      bronchodilator properties.

      The literature search establishes that addition of an antihistamine to montelukast has added
      benefit. The combination therapy of montelukast with antihistamine provide enhancing and
      complimentary effects thereby reducing the symptoms effectively. The results with concomitant
      levocetirizine and montelukast treatment are better as compared to monotherapy with
      levocetirizine on symptoms and quality of life in allergic rhinitis. Fexofenadine along with
      montelukast is more effective than antihistaminic alone in control of allergic rhinitis
      symptoms. There is literature available for the comparisons of concomitant levocetirizine and
      montelukast with monotherapy or placebo and comparisons of concomitant fexofenadine and
      montelukast with monotherapy or placebo. But scanty data is available regarding comparisons
      of concomitant montelukast-levocetirizine with montelukast-fexofenadine.
    

Intervention name(s): Montelukast; Fexofenadine; Levocetrizine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): group B received FDC tablet of montelukast 10mg and fexofenadine 120 mg O.D; group A recieved FDC tablet of montelukast 10 mg and levocetrizine 5mg O.D
Intervention MeSH terms: Fexofenadine; Montelukast; Levocetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Allergic rhinitis; montelukast; fexofenadine; levocetrizine