Back to results

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

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

NCT ID

NCT04324918

First Posted

February 4, 2020

Last Updated

March 26, 2020

Sponsor

Hanmi Pharmaceutical Company Limited

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

Time Frame

baseline, 3-4week(2weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

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

We'll reach out to this number within 24 hrs