Health Condition 1: - Health Condition 2: J00-J99- Diseases of the respiratory system
Conditions
Interventions
Intervention1: Fixed Dose combination of Levocetrizine Hydrochloride 5 mg and Montelukast 10mg: A Post Market Surveillance study of Fixed Dose combination of Levocetrizine Hydrochloride 5 mg and Monte
Sponsors
Fourrts India Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Willing and able to sign informed consent form. Written informed consent must be obtained before any assessment is performed • Patients with history of SAR prior to the study • Patients who agree to maintain consistency in their surroundings throughout the study period. • Were patients from outpatient department of ENT and general physician between the age group of 18â??65 years of either gender having moderate-severe intermittent or mild persistent AR according to original ARIA classification. • The study inclusion criteria required the patients with total nasal symptom score (TNSS) of 5 or higher, not treated with antihistaminics in the previous week.
Exclusion criteria
Exclusion criteria: Hypersensitivity to Levocetirizine Hydrochloride 5 mg and Montelukast 10 mg or any excipients • Patients with upper respiratory tract infection or acute/chronic pulmonary disorder • Patients also with non-allergic rhinitis with different causes. • Patients with severe asthma. • Presence of nasal polyps or any clinically important nasal anomaly. • History of acute/chronic sinusitis within 30 days of Visit 1 • History of intranasal / eye surgeries within 3 months of Visit 1 • Initiation of immunotherapy or dose modification within 1 month prior to Visit 1 • Have presence of any condition that in the opinion of the physician places the patient at undue risk or potentially jeopardizes the quality of data to be generated. • Patient requiring other anti- histamine, corticosteroids (oral and/parenteral), immunotherapy, cromolyn sodium, nedocromil and inhaled cholinergics, oral or long acting beta-agonist, theophylline, tricyclic antidepressants, other leukotriene modifiers and bronchodilators, etc that may affect the efficacy of study drug are not enrolled in the study. • Decongestants, anti-inflammatory medicines and other rescue medicines for allergic rhinitis are not permitted during the study. • Should not be suffering from any other psychiatric illness or any other chronic disease which would interfere with trial assessments. • Known contraindication for the use of Levocetirizine Hydrochloride and Montelukast • A history of drug or alcohol abuse within the past 6 months • Currently participating (or participated within the previous 30 days) in an investigational therapeutic or device study • Female who is pregnant, nursing, or of child-bearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To collect and assess safety of fixed dose combination of levocetirizine 5mg + montelukast 10mg in patients with seasonal allergic rhinitisTimepoint: To monitor adverse events (AEs)/adverse drug reaction (ADR), serious adverse events (SAEs)/ serious adverse drug reactions (SADRs), unexpected AE/ADR and unexpected SAE/SADR | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy will be evaluated as change in day time nasal symptom score (average of scores of nasal congestion, rhinorrhea, itching and sneezingTimepoint: Efficacy from baseline to end of the treatment | — |
Countries
India
Contacts
Public ContactMrVairamuthuAmmaiyappam
IDD Research Solutions Pvt Ltd
Outcome results
None listed