search
Back to results

Efficacy and Safety of HCP1102 Capsule

Primary Purpose

Asthma With Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HCP1102+HGP0711Placebo
HCP1102Placebo+HGP0711
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma With Allergic Rhinitis focused on measuring Asthma, Allergic rhinitis

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Soon Chun Hyang University Hospital Bucheon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HCP1102+HGP0711Placebo

HCP1102Placebo+HGP0711

Arm Description

HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily

HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily

Outcomes

Primary Outcome Measures

Change of Mean Daytime Nasal Symptom Score

Secondary Outcome Measures

Change of Mean Daytime Nasal Symptom Score
Change of Runny nose (Mean Daytime Nasal Symptom Score)
Change of Mean Nighttime Nasal Symptom Score
Change of Mean Composite Symptom Score
Change of sneezing (Mean Daytime Nasal Symptom Score)
Change of pruritus (Mean Daytime Nasal Symptom Score)

Full Information

First Posted
September 7, 2015
Last Updated
September 16, 2015
Sponsor
Hanmi Pharmaceutical Company Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT02552667
Brief Title
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

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma With Allergic Rhinitis
Keywords
Asthma, Allergic rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
228 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCP1102+HGP0711Placebo
Arm Type
Experimental
Arm Description
HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily
Arm Title
HCP1102Placebo+HGP0711
Arm Type
Active Comparator
Arm Description
HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily
Intervention Type
Drug
Intervention Name(s)
HCP1102+HGP0711Placebo
Intervention Description
Coadministration of HCP1102 with HGP0711 Placebo for 4-week
Intervention Type
Drug
Intervention Name(s)
HCP1102Placebo+HGP0711
Intervention Description
Coadministration of HCP1102 Placebo with HGP0711 for 4-week
Primary Outcome Measure Information:
Title
Change of Mean Daytime Nasal Symptom Score
Time Frame
base line, 3-4week(2weeks)
Secondary Outcome Measure Information:
Title
Change of Mean Daytime Nasal Symptom Score
Time Frame
base line, 1-2week(2weeks), 3-4week(2weeks)
Title
Change of Runny nose (Mean Daytime Nasal Symptom Score)
Time Frame
base line, 1-2week(2weeks), 3-4week(2weeks)
Title
Change of Mean Nighttime Nasal Symptom Score
Time Frame
base line, 1-2week(2weeks), 3-4week(2weeks)
Title
Change of Mean Composite Symptom Score
Time Frame
base line, 1-2week(2weeks), 3-4week(2weeks)
Title
Change of sneezing (Mean Daytime Nasal Symptom Score)
Time Frame
base line, 1-2week(2weeks), 3-4week(2weeks)
Title
Change of pruritus (Mean Daytime Nasal Symptom Score)
Time Frame
base line, 1-2week(2weeks), 3-4week(2weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Choon-Sik Park, M.D., Ph.D.
Organizational Affiliation
Soon Chun Hyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon
State/Province
Gyunggi -do
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29945738
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.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of HCP1102 Capsule

We'll reach out to this number within 24 hrs