A randomized, open label, prospective, two arm, comparative multicentric study to evaluate the efficacy and safety of montelukast and fexofenadine fixed dose combination vs montelukast and levocetirizine fixed dose combination in the management of patients with allergic rhinitis

Abbott Healthcare Pvt Ltd0 个研究点目标入组 120 人开始时间: 待定最近更新: 2021年11月24日

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•1.Males and females patients more than 18 years of age.
•2.Patients with diagnosis of Allergic Rhinitis (patients with a total nasal symptom score (TNSS; the sum of all the 4 individual nasal symptom scores) of 6 or greater and/or a total ocular symptom score (TOSS; the sum of all the 3 individual ocular symptom scores) of 4 or greater.)
•3.Except Allergic Rhinitis, patients must be in general good health based on screening.
•4.Patients having bronchial symptoms along with Allergic Rhinitis are also allowed to participate in the study.
•5.Patients must give written informed consent after reading the Patient Information sheet and Informed Consent Form and having had the opportunity to discuss the study with the Investigator.
•6.Patient willing to follow up and comply with the Protocol requirements

•1.Males and females patients less than 18 years of age.
•2.Pregnant and lactating women patients.
•3.Patients not willing to comply with the study protocol and provide written informed consent to participate.
•4.Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 month before the trial.
•5.Patients with upper respiratory tract infection or acute or chronic pulmonary disorder.
•6.Patients with known hypersensitivity to Montelukast or Fexofenadine or other piperazine derivatives.
•7.Expected use of any other medications for allergic rhinitis or conjunctivitis during the treatment period e.g. antihistamines, corticosteroids (inhaled, oral, parenteral, nasal and ophthalmic), cromolyn sodium, nedocromil and inhaled cholinergics.
•8.Medications that could affect nasal or ocular symptoms including decongestants and anti-inflammatory drugs are not permitted.
•9.No allergic rhinitis rescue medications are permitted during the study.
•10.Patient not willing to participate in the trial

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