A Study to Evaluate the Safety of Combination Montelukast/Loratadine in Mexican Participants With Allergic Rhinitis (MK-0476A-484)
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Intervention: Montelukast 10 mg/loratadine 10 mg; Placebo
Intervention description: Montelukast 10 mg/loratadine 10 mg tablet administered once daily; Matching placebo tablet administered once daily
Intervention MeSH terms: Loratadine; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 69.0
Sex: All
Minimum age: 15 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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