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Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis

Primary Purpose

Perennial Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HCP1102
HGP1408
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial Allergic Rhinitis

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with at least 2 years history of PAR prior to the study
  • Positive results of skin prick test
  • Patients who provided a signed written informed consent form
  • Patients who are able and willing to complete subject diaries
  • Patients who agree to maintain consistency in their surroundings throughout the study period

Exclusion Criteria:

  • Patients also with non-allergic rhinitis with different causes.
  • Patients with severe asthma.
  • History of acute • chronic sinusitis within 1 month of Visit 1
  • History of intranasal surgeries within 3 months of Visit 1
  • Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
  • Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.
  • Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug.

Sites / Locations

  • Gangnam Severance Hospital.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HCP1102

HGP1408

Arm Description

Outcomes

Primary Outcome Measures

Change of Mean Daytime Nasal Symptom Score
Daytime nasal symptoms included rhinorrhea, nasal obstruction, sneezing, and itching, each scored from 0 to 3 (0 = none, 1 = mild, 2 = moderate and 3 = severe).

Secondary Outcome Measures

Change of Mean Nighttime Nasal Symptom Score
Nighttime nasal symptoms included nasal obstruction awakening (0 = none; 1 = mild; 2 = moderate; 3 = severe), difficulty getting to sleep (0 = not at all; 1 = little; 2 = moderate; 3 = severe), and nighttime awakening (0 = not at all; 1 = once; 2 = more than once; 3 = awake all night).

Full Information

First Posted
February 4, 2020
Last Updated
March 26, 2020
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04324918
Brief Title
Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis
Official Title
Efficacy and Safety of HCP1102 in Patients With Perennial Allergic Rhinitis : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 23, 2018 (Actual)
Primary Completion Date
June 24, 2019 (Actual)
Study Completion Date
June 24, 2019 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis : 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
Perennial Allergic Rhinitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
HCP1102
Arm Type
Experimental
Arm Title
HGP1408
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
HCP1102
Intervention Description
The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.
Intervention Type
Drug
Intervention Name(s)
HGP1408
Intervention Description
The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.
Primary Outcome Measure Information:
Title
Change of Mean Daytime Nasal Symptom Score
Description
Daytime nasal symptoms included rhinorrhea, nasal obstruction, sneezing, and itching, each scored from 0 to 3 (0 = none, 1 = mild, 2 = moderate and 3 = severe).
Time Frame
base line, 3-4week(2weeks)
Secondary Outcome Measure Information:
Title
Change of Mean Nighttime Nasal Symptom Score
Description
Nighttime nasal symptoms included nasal obstruction awakening (0 = none; 1 = mild; 2 = moderate; 3 = severe), difficulty getting to sleep (0 = not at all; 1 = little; 2 = moderate; 3 = severe), and nighttime awakening (0 = not at all; 1 = once; 2 = more than once; 3 = awake all night).
Time Frame
baseline, 3-4week(2weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with at least 2 years history of PAR prior to the study Positive results of skin prick test Patients who provided a signed written informed consent form Patients who are able and willing to complete subject diaries Patients who agree to maintain consistency in their surroundings throughout the study period Exclusion Criteria: Patients also with non-allergic rhinitis with different causes. Patients with severe asthma. History of acute • chronic sinusitis within 1 month of Visit 1 History of intranasal surgeries within 3 months of Visit 1 Initiation of immunotherapy or dose modification within 1 month prior to Visit 1 Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1. Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung-Su Kim, M.D., Ph.D.
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gangnam Severance Hospital.
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis

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