Clinical trial NCT02498509: Clinical Trial to Evaluate the Efficacy and Safety of CKD-342
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Perennial
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2015-07-15
Enrollment: 459
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: change in rTNSS from baseline
timeFrame: up to week 4
Secondary outcomes:
measure: change in rTNSS from baseline
timeFrame: up to week 2
measure: change in AM rTNSS and PM rTNSS from baseline
timeFrame: 2 weeks and 4 weeks after the baseline assessment
measure: Physician assessed overall nasal symptom from baseline
timeFrame: 2 weeks and 4 weeks after the basline assessment
measure: change from baseline in RQLQ
timeFrame: 2 weeks and 4 weeks after the baseline assessment
measure: Changing in 4 nasal symptom score (sneezing, runny nose, nasal congestion, itchy nose) from baseline
timeFrame: 2 weeks and 4 weeks after the basline assessment
Other outcomes:
Locations:
city: Irwon-dong
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu, Seoul
Study officials:
References: