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

Hanmi Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: HGP1408; Drug: HCP1102

Study type: Interventional

Funder types: Industry

Identifiers

NCT04324918

HM-MOLZ-303

Details and patient eligibility

About

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

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

Enrollment: 174 patients

Sex: All

Ages: 15+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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174 participants in 2 patient groups

HCP1102

Experimental group

Treatment:

Drug: HCP1102

HGP1408

Active Comparator group

Treatment:

Drug: HGP1408