Efficacy and safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) patients

Efficacy and safety of Concomitant Montelukast Sodium and Levocetirizine Dihydrochloride in Perennial Allergic Rhinitis (PAR) patients : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000484

Enrollment

280

Registered

2012-07-18

Start date

2012-06-12

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Singulair tablet 10 mg / Xyzal tablet 5 mg, Once daily, before bedtime, oral administration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
Change in Mean Daytime Nasal Symptom Score from baseline at Weeks 3-4 (2 weeks) of treatment	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Korea, Republic of

Contacts

Public ContactChoonSik Park

Soon Chun Hyang University Hospital Seoul

Outcome results