Perennial Allergic Rhinitis Clinical Trial
Official title:
A Randomized, Parallel, Double-blind, Multi-center, Comparative Study to Exploratively Evaluate the Efficacy and Safety of Cosalin® Monotherapy vs. Cosalin® and Xarlin® Combination Therapy in Patients With Allergic Rhinitis
Title of Study:
A randomized, parallel, double-blind, multi-center, comparative study to evaluate the
efficacy and safety of Cosalin monotherapy versus Cosalin and Xarlin combination therapy in
patients with allergic rhinitis
Objective of study:
To exploratively evaluate superiority of combination therapy - twice-daily Cosalin Tab
(Petasites hybridus CO2 extract) with once-daily Xarlin Tab (Levocetirizine HCl) - compared
to monotherapy of Cosalin with allergic rhinitis subjects.
Number of Subjects:
Total 100 subjects / Each group 50 subjects (combination therapy group, monotherapy group /
include 20% of subjects drop out rate)
Test Products:
Cosarlin (Petasites hybridus CO2 extract) 30 mg tablet Xarlin (Levocetirizine HCl) 5 mg
tablet
Study Design:
Development Phase: Phase IV Randomized, double blind, active-controlled, multi-center study
The subject, who is to satisfy inclusion criteria and not to satisfy any of exclusion
criteria will be allocated 1:1 to combination therapy group or mono therapy group,
randomized.
Written informed consent will be obtained from the subjects prior to study entry.
Dose, Mode of administration:
Monotherapy group - Cosalin 30mg tablet two times daily. Combination therapy group - Cosalin
30mg tablet two times daily and Xarlin 5mg tablet once daily.
Duration of Tx:
2 Weeks
Safety Endpoint:
Physical Exam, Adverse Events, Vital Signs at Visit 2 and 3.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01654536 -
A 6 Month Safety Study Of Ciclesonide Nasal Aerosol (Zetonna®) And Ciclesonide Nasal Spray (Omnaris®) In Subjects 12 Years And Older With Perennial Allergic Rhinitis (PAR)
|
Phase 4 | |
| Completed |
NCT01221285 -
Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium
|
Phase 1 | |
| Completed |
NCT01539304 -
Clinical Trial to Evaluate the Safety and Efficacy of "CITUS Dry Syrup" in Children With Perennial Allergic Rhinitis
|
Phase 3 | |
| Terminated |
NCT00491374 -
Study of Nasonex® in Improving Sleep Disturbances Related to Perennial Allergic Rhinitis (Study P04909)(TERMINATED)
|
Phase 4 | |
| Completed |
NCT00783224 -
A Comparative Study of Mometasone Furoate Nasal Spray and Fluticasone Propionate Nasal Spray in Patients With Perennial Allergic Rhinitis (Study P04512)
|
Phase 3 | |
| Completed |
NCT04324918 -
Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis
|
Phase 3 | |
| Completed |
NCT02532179 -
Subcutaneous Immunotherapy for Mouse in Adults
|
Phase 1/Phase 2 | |
| Completed |
NCT01451541 -
A Safety and Efficacy Study of Ciclesonide Nasal Aerosol in Subjects 6-11 Years With Perennial Allergic Rhinitis (PAR).
|
Phase 3 | |
| Completed |
NCT00405899 -
Pilot Study of Allergy Immunotherapy and Prevention of Viral Respiratory Infections
|
N/A | |
| Completed |
NCT01549340 -
Retrospective Record Review of Adults and Children Advised for Allergen Immunotherapy (MK-7243-022)
|
N/A | |
| Completed |
NCT01018862 -
A Study to Evaluate the Safety and Efficacy of a Nasal Spray to Treat Children With Perennial Allergic Rhinitis
|
Phase 3 | |
| Completed |
NCT00789555 -
Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis
|
Phase 4 | |
| Completed |
NCT00261287 -
Safety and Tolerability of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis (2-5 Years Old) (BY9010/M1-416)
|
Phase 3 | |
| Completed |
NCT00974571 -
Montelukast in Perennial Allergic Rhinitis - 2001-2002 Study (0476-246)
|
Phase 3 | |
| Completed |
NCT04654702 -
Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.
|
||
| Completed |
NCT05122143 -
Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers
|
N/A | |
| Completed |
NCT01380327 -
Biomarkers of Cockroach Sublingual Immunotherapy 2
|
Phase 1/Phase 2 | |
| Completed |
NCT01116778 -
the Efficacy and Safety of Probiotics eN-Lac® Capsules of Children With Perennial Allergic Rhinitis
|
Phase 3 | |
| Completed |
NCT00359216 -
The Effects of Mometasone Furoate Nasal Spray in Subjects With Sleep-disordered Breathing (SDB) Associated With Perennial Allergic Rhinitis (Study P04726)
|
Phase 4 | |
| Completed |
NCT01127620 -
Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension
|
Phase 3 |