Clinical trial NCT02552667: Efficacy and Safety of HCP1102 Capsule
Official title: Efficacy and Safety of HCP1102 Capsule : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma With Allergic Rhinitis
Keywords: Asthma
Allergic rhinitis
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2015-09-17
Enrollment: 228
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.


Eligibility criteria: Inclusion:

* Age≥15
* Mild or moderate asthma patients with allergic rhinitis
* Patient who meet all criteria of rhinitis
* Patients understood the contents and purpose of this trial and signed informed consent form
* Patients who are capable and willing to write subject diary
* Patients who agree with maintain same environment during clinical trials

Exclusion:

* Nonallergic rhinitis
* Severe asthma
* Other pulmonary disease (pulmonary tuberculosis, COPD) except Asthma
* Medical history of hypertrophic cardiomyopathy, cancer, renal disease, Liver disease, cardiovascular disease, respiratory disease, endocrine disorder, CNS disorder that effect safety
* Medical history of gastrointestinal surgery or gastrointestinal disorders that effect drug absorption
* Alcohol abuse or Drug abuse
* Genetic factor of galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
* pregnant or breast-feeding women or men/women of childbearing age that they don't use contraceptives
* Patient who administered other investigational products within 30 days
* Current smoker Judged to be inappropriate for the study by the investigator after reviewing other reasons

Primary outcomes:
measure: Change of Mean Daytime Nasal Symptom Score
timeFrame: base line, 3-4week(2weeks)
Secondary outcomes:
measure: Change of Mean Daytime Nasal Symptom Score
timeFrame: base line, 1-2week(2weeks), 3-4week(2weeks)
measure: Change of Runny nose (Mean Daytime Nasal Symptom Score)
timeFrame: base line, 1-2week(2weeks), 3-4week(2weeks)
measure: Change of Mean Nighttime Nasal Symptom Score
timeFrame: base line, 1-2week(2weeks), 3-4week(2weeks)
measure: Change of Mean Composite Symptom Score
timeFrame: base line, 1-2week(2weeks), 3-4week(2weeks)
measure: Change of sneezing (Mean Daytime Nasal Symptom Score)
timeFrame: base line, 1-2week(2weeks), 3-4week(2weeks)
measure: Change of pruritus (Mean Daytime Nasal Symptom Score)
timeFrame: base line, 1-2week(2weeks), 3-4week(2weeks)
Other outcomes:
Locations:
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Bucheon
state: Gyunggi -do
Study officials:
affiliation: Soon Chun Hyang University
name: Choon-Sik Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim MK, Lee SY, Park HS, Yoon HJ, Kim SH, Cho YJ, Yoo KH, Lee SK, Kim HK, Park JW, Park HW, Chung JH, Choi BW, Lee BJ, Chang YS, Jo EJ, Lee SY, Cho YS, Jee YK, Lee JM, Jung J, Park CS. A Randomized, Multicenter, Double-blind, Phase III Study to Evaluate the Efficacy on Allergic Rhinitis and Safety of a Combination Therapy of Montelukast and Levocetirizine in Patients With Asthma and Allergic Rhinitis. Clin Ther. 2018 Jul;40(7):1096-1107.e1. doi: 10.1016/j.clinthera.2018.04.021. Epub 2018 Jun 24.