Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis

September 15, 2015 updated by: DR.MOHINI MAHATME, Indira Gandhi Medical College, Shimla

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

70

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
4 week
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
4 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indira Gandhi Medical College, Shimla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 12, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 16, 2015

Study Record Updates

Last Update Posted (Estimate)

September 16, 2015

Last Update Submitted That Met QC Criteria

September 15, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEC/425-26/13

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.

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