A study to evaluate the efficacy and safety of 2 study drugs in treatment of patients with allergic rhinitis

Phase 4

Completed

• Conditions: Health Condition 1: null- Male and female subjects of 18 years and above with allergic rhinitis

• Registration Number: CTRI/2012/08/002941
• Lead Sponsor: Abbott Healthcare Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified