Perennial Allergic Rhinitis
Conditions
Brief summary
Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial
Interventions
DRUGHCP1102
The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.
DRUGHGP1408
The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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
* Patients also with non-allergic rhinitis with different causes. * Patients with severe asthma. * History of acute • chronic sinusitis within 1 month of Visit 1 * History of intranasal 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Mean Daytime Nasal Symptom Score | base line, 3-4week(2weeks) | Daytime nasal symptoms included rhinorrhea, nasal obstruction, sneezing, and itching, each scored from 0 to 3 (0 = none, 1 = mild, 2 = moderate and 3 = severe). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Mean Nighttime Nasal Symptom Score | baseline, 3-4week(2weeks) | Nighttime nasal symptoms included nasal obstruction awakening (0 = none; 1 = mild; 2 = moderate; 3 = severe), difficulty getting to sleep (0 = not at all; 1 = little; 2 = moderate; 3 = severe), and nighttime awakening (0 = not at all; 1 = once; 2 = more than once; 3 = awake all night). |
Countries
South Korea
Outcome results
None listed