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

NCT04324918 | Completed Phase 3

• 1 other identifier: HM-MOLZ-303
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

Brief Summary

Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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).

  base line, 3-4week(2weeks)

Secondary Outcomes (1)

• Change of Mean Nighttime Nasal Symptom Score

  baseline, 3-4week(2weeks)

Study Arms (2)

HCP1102

EXPERIMENTAL

Drug: HCP1102

HGP1408

ACTIVE COMPARATOR

Drug: HGP1408

Interventions

HCP1102 DRUG

The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.

HCP1102

HGP1408 DRUG

The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.

HGP1408

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Gangnam Severance Hospital.

Seoul, South Korea

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Kyung-Su Kim, M.D., Ph.D.

  Gangnam Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2020
• First Posted: March 27, 2020
• Study Start: October 23, 2018
• Primary Completion: June 24, 2019
• Study Completion: June 24, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

KR (1)