Efficacy and safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) patients
- Conditions
- Diseases of th respiratory system
- Registration Number
- KCT0000484
- Lead Sponsor
- Hanmi Pharm
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 280
Patients with at least 2 years history of PAR prior to the study
- Positive results of skin prick test
- Patients who provided a signed written informed consent form
- Patients who are able and willing to complete subject diaries
- Patients who agree to maintain consistency in their surroundings throughout the study period
- 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
- Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.
- Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug
- At Visit 2, patients who recorded Daytime Nasal Symptom Scores for fewer than 4 days in the subject diary during the last one week of baseline period
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 3-4 (2 weeks) of treatment
- Secondary Outcome Measures
Name Time Method Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 1-2 (2 weeks) of treatment ;Change in Mean Nighttime Nasal Symptom from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment ;Change in Mean Composite Symptom Score from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment ;Change in Mean Daytime Eye Symptom Score from baseline at Weeks 1-2 (2 weeks) and Weeks 3-4 (2 weeks) of treatment