A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484)

A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety of Combination Montelukast/Loratadine (MK-0476A) in Mexican Patients With Allergic Rhinitis

The purpose of this study is to assess the safety and tolerability of montelukast 10 mg/loratadine 10 mg versus placebo in Mexican participants with allergic rhinitis.

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Drug: Montelukast 10 mg/loratadine 10 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Not pregnant or breastfeeding and does not plan to become pregnant during the study and the 14-day follow-up period
• Female participants of reproductive potential agree to remain abstinent or use one acceptable method of birth control at least 14 days prior to signing the informed consent until 14 days following the last visit
• History for at least 2 years of seasonal allergic rhinitis symptoms that are known to flare during the local allergy season or a clinical history of at least 2 years of perennial allergic rhinitis symptoms that persist year round
• For participants with seasonal allergic rhinitis: a positive skin-prick test (wheal >= 3 mm greater than saline control) to one of the allergens active during the local allergy season or a positive radioallergosorbent test (RAST [defined as a score >= Class III])
• For participants with perennial allergic rhinitis: a positive skin test (wheal >=3 mm greater than saline control) to one of the relevant perennial allergens or a positive RAST (defined as a score >= Class III)
• Nonsmoker and has been a nonsmoker for at least 1 year prior to study Visit 1 with a smoking history of no more than 10 pack-years (1 pack [20 cigarettes] per day for 10 years)
• Must be in good and stable physical health and mental health

Exclusion Criteria:

• Hospitalization or hospitalization within 4 weeks of the first scheduled study visit
• Pregnancy or within <= 8 weeks postpartum or is breast feeding
• Any major surgical procedure within 4 weeks of the first scheduled study vist
• Current or recent past abuser of alcohol or illicit drugs
• Prior participation in a clinical trial of montelukast or loratadine within the 4 weeks prior to the first scheduled study visit

• Requires treatment other than inhaled short-acting β-agonist for asthma

  (e.g., inhaled or oral corticosteroid, theophylline, nedocromil, cromolyn, oral or long-acting inhaled β-agonist, leukotriene receptor antagonist, leukotriene synthesis inhibitor) and/or uses more than 8 puffs per day of inhaled short-acting β-agonist

• Presence of an upper respiratory tract infection (URI), sinusitis, infectious rhinitis (with symptoms such as sore throat, fever, thick purulent rhinorrhea), ocular infection, or history of any of these within 4 weeks prior to the first scheduled study visit or any time between study Visits 1 and 2
• Other than asthma, any active, acute, or chronic pulmonary disorder which is documented by history or physical examination
• Rhinitis medicamentosa, or non-allergic rhinitis
• Recent history (within 3 months prior to the first scheduled study visit) of a clinically significant psychiatric disorder
• History of an anaphylactic reaction to or is otherwise hypersensitive to

montelukast, loratadine, or one of their components

• History or current evidence of any general medical condition, concomitant therapy, lab abnormality or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study
• History of illness that would require treatment with an excluded medication, could be immediately life threatening (ventricular arrhythmia, diabetes mellitus that is not well controlled), would pose restriction on participation or successful completion of the study, or would pose additional risk to the patient by administering the study drug
• History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Montelukast 10 mg/loratadine 10 mg; Montelukast 10 mg/loratadine 10 mg combination tablet administered orally once daily for 2 weeks	Drug: Montelukast 10 mg/loratadine 10 mg; Montelukast 10 mg/loratadine 10 mg tablet administered once daily; Other Names: MK-0476A
Placebo Comparator: Placebo; Matching placebo tablet administered orally once daily for 2 weeks	Drug: Placebo; Matching placebo tablet administered once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing at Least One Adverse Event (AE)	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.	Up to 4 weeks
Number of Participants Discontinuing Study Treatment Due to AEs	An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study treatment, whether or not considered related to the use of the study treatment.	Up to 2 weeks

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2012
• Primary Completion (Actual): October 10, 2012
• Study Completion (Actual): October 10, 2012

Study Registration Dates

• First Submitted: August 3, 2012
• First Submitted That Met QC Criteria: August 23, 2012
• First Posted (Estimated): August 28, 2012

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Montelukast; Loratadine
• Other Study ID Numbers: 0476A-484

Plan for Individual participant data (IPD)

Study Data/Documents

1. CSR Synopsis