Montelukast and Fexofenadine Versus Montelukast and Levocetrizine Combination in Allergic Rhinitis

NCT02551536 | Completed Phase 4 DMC

• 1 other identifier: IEC/425-26/13
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis; montelukast; fexofenadine; levocetrizine

Outcome Measures

Primary Outcomes (2)

• Total Nasal Symptom Score (TNSS)

  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

  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 Outcomes (1)

• cost effectiveness ratio

  4 weeks

Study Arms (2)

Group A

ACTIVE COMPARATOR

FDC tablet of montelukast 10 mg and levocetrizine 5 mg was given once daily for 4 weeks

Drug: Montelukast; Drug: Levocetrizine

Group B

EXPERIMENTAL

FDC tablet of montelukast 10 mg and fexofenadine 120 mg was given once daily for 4 weeks

Drug: Montelukast; Drug: Fexofenadine

Interventions

Montelukast DRUG

Group A; Group B

Fexofenadine DRUG

group B received FDC tablet of montelukast 10mg and fexofenadine 120 mg O.D

Group B

Levocetrizine DRUG

group A recieved FDC tablet of montelukast 10 mg and levocetrizine 5mg O.D

Group A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indira Gandhi Medical College, Shimla: lead

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

montelukast; fexofenadine; levocetirizine

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: August 12, 2015
• First Posted: September 16, 2015
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 16, 2015

Record last verified: 2015-09