Rhinitis, Allergic, Perennial
Conditions
Brief summary
Clinical Trial to Evaluate the Efficacy and Safety of CKD-342
Detailed description
A Randomized, Double-blind, Active-controlled, Multicenter phase 3 Clinical trial to evaluate the Efficacy and Safety of Concomitant Mometasone furoate and Levocabastine HCl in Perennial Allergic Rhinitis patients
Interventions
DRUGCKD-342
treatment for 4 weeks after randomization
DRUGMometasone furoate
treatment for 4 weeks after randomization
DRUGLevocabastine HCL
treatment for 4 weeks after randomization
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. male, female, Age: over 13 years(no age limiation in upper) 2. subject who has experienced perennial allergic rhinitis for over 1 year 3. subject who has identified allergens throughout the year within 12 months 4. subject who has the symptoms of moderate to severe allergic rhinitis 5. subject who can record the the patient diary during the clinical trial period 6. subject who agreed to keep the same environment during the clinical trial period
Exclusion criteria
1. Asthma 2. Previous medical history at screening (Nasal polyps within the previous two months, biopsies, ulcers, trauma, surgery, atrophic rhinitis, patients with a history of drug rhinitis) 3. Patients with untreated localized infection in nasal mucosa 4. Patients following administration of a combination of prohibited drugs in patients administered concomitant medications or trial period is expected to be inevitable 5. Patients with abnormal following laboratory test results at screening * AST, ALT\>2times the upper limit of normal at screening * Serum creatinine \>1.5times the upper limit of normal at screening 6. Previous history of acute or severe chronic sinusitis within 30 days at screening 7. The continue use of drugs that may affect the efficacy of the Investigational product 8. Start the immunotherapy or a change of doge within 1 month, at screening 9. If you have glaucoma or cataracts, herpes simplex, or around the eyes 10. Chronic obstructive pulmonary disease (COPD) 11. history of hypersensitivity reactions and for treaties or major components of the IP 12. Pregnant women, breast feeding women or women of childbearing potential must agree to use appropriate contraception methods 13. Alcohol or illegal drug abuse or dependence in patients 14. participation in any investigational or maketed drug within 4weeks preceding the screening visit 15. Patients that can not be participating in a clinical trial by investigator's discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in rTNSS from baseline | up to week 4 |
Secondary
| Measure | Time frame |
|---|---|
| change in rTNSS from baseline | up to week 2 |
| change in AM rTNSS and PM rTNSS from baseline | 2 weeks and 4 weeks after the baseline assessment |
| Physician assessed overall nasal symptom from baseline | 2 weeks and 4 weeks after the basline assessment |
| change from baseline in RQLQ | 2 weeks and 4 weeks after the baseline assessment |
| Changing in 4 nasal symptom score (sneezing, runny nose, nasal congestion, itchy nose) from baseline | 2 weeks and 4 weeks after the basline assessment |
Countries
South Korea
Outcome results
None listed