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

Perennial Allergic Rhinitis Clinical Trial

Official title:

Efficacy and Safety of HCP1102 in Patients With Perennial Allergic Rhinitis : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04324918
• Other study ID #: HM-MOLZ-303
• Status: Completed
• Phase: Phase 3
• Start date: October 23, 2018
• Est. completion date: June 24, 2019

Study information

• Verified date: March 2020
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: June 24, 2019
• Est. primary completion date: June 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

Drug:
• HCP1102
The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.
• HGP1408
The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.

Locations

Country	Name	City	State
Korea, Republic of	Gangnam Severance Hospital.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	baseline, 3-4week(2weeks)