Trial record 58 of 66 for:    Levocetirizine

Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02551536
Recruitment Status : Completed
First Posted : September 16, 2015
Last Update Posted : September 16, 2015
Information provided by (Responsible Party):
DR.MOHINI MAHATME, Indira Gandhi Medical College

Brief 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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: Montelukast Drug: Fexofenadine Drug: Levocetrizine Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy, Safety and Cost Effectiveness of Montelukast and Levocetirizine Versus Montelukast and Fexofenadine in Patients of Allergic Rhinitis: a Randomized, Double-blind Clinical Trial
Study Start Date : April 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Active Comparator: Group A
FDC tablet of montelukast 10 mg and levocetrizine 5 mg was given once daily for 4 weeks
Drug: Montelukast
Drug: Levocetrizine
group A recieved FDC tablet of montelukast 10 mg and levocetrizine 5mg O.D

Experimental: Group B
FDC tablet of montelukast 10 mg and fexofenadine 120 mg was given once daily for 4 weeks
Drug: Montelukast
Drug: Fexofenadine
group B received FDC tablet of montelukast 10mg and fexofenadine 120 mg O.D

Primary Outcome Measures :
  1. Total Nasal Symptom Score (TNSS) [ Time Frame: 4 week ]
    The TNSS was obtained from the sum of all four individual symptom scores, with a total possible score ranging from 0 (no symptoms) to 12 (maximum symptom intensity).

  2. adverse drug reaction [ Time Frame: 4 week ]
    General clinical safety was monitored by vigilant follow-up of patients for the treatment of emergent adverse events if any, and recorded in the case report form

Secondary Outcome Measures :
  1. cost effectiveness ratio [ Time Frame: 4 weeks ]

    direct cost parameters were taken into consideration. Direct cost parameters were cost of medications used, medical procedures and hospitalization charges, if any. Cost-effectiveness ratio of both treatment groups were calculated based on formula as given below.

    Cost-effectiveness ratio = cost / outcome Outcome was measured in terms of effectiveness. TNSS parameter was the main effectiveness parameter.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • either gender having moderate-severe intermittent or mild persistent allergic rhinitis according to original Aria classification.
  • subjects with Total Nasal Symptom Score (TNSS) of 5 or higher.
  • not treated with antihistaminics in previous week.
  • Patients willing to sign written informed consent
  • free of any clinically significant disease
  • having normal E.C.G

Exclusion Criteria:

  • participation of children, pregnant female, nursing mothers,
  • patients with asthma requiring chronic use of inhaled or systemic corticosteroids
  • history of failure to improve symptoms with antihistaminic drug treatment in the past 4.history of allergies to study medication or tolerance to antihistamines, 5.use of study drug in the last 7 days. 6. subjects with significant hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric or autoimmune disease

Responsible Party: DR.MOHINI MAHATME, ASSOCIATE PROFESSOR, Indira Gandhi Medical College Identifier: NCT02551536     History of Changes
Other Study ID Numbers: IEC/425-26/13
First Posted: September 16, 2015    Key Record Dates
Last Update Posted: September 16, 2015
Last Verified: September 2015

Keywords provided by DR.MOHINI MAHATME, Indira Gandhi Medical College:
Allergic rhinitis

Additional relevant MeSH terms:
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents