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

• Status: Completed
• Trial end date: 2019-06-24
• Target enrollment: 0
• Participant gender: All

Summary

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

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited

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.