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

Phase 3

Completed

• Conditions: Perennial Allergic Rhinitis
• Interventions: Drug: HGP1408; Drug: HCP1102

• Registration Number: NCT04324918
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis :

A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-23
• Primary Completion: 2019-06-24
• Study Completion: 2019-06-24
• Study First Submitted: 2020-02-04
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-26
• Last Update Submitted: 2020-03-26
• Study First Posted: 2020-03-27
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HGP1408	HGP1408	-
HCP1102	HCP1102	-

Primary Outcome Measures

Name	Time	Method
Change of Mean Daytime Nasal Symptom Score	base line, 3-4week(2weeks)	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

Name	Time	Method
Change of Mean Nighttime Nasal Symptom Score	baseline, 3-4week(2weeks)	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).

Trial Locations

Locations (1)

Gangnam Severance Hospital.; 🇰🇷 Seoul, Korea, Republic of