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NCT Number: NCT04324918

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

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

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

Completed

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Key information

Conditions

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

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gangnam Severance Hospital.

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HCP1102

Drug

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

HGP1408

Drug

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

Primary outcomes

  1. Change of Mean Daytime Nasal Symptom Score

    Time frame: 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 outcomes

  1. Change of Mean Nighttime Nasal Symptom Score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 27, 2020
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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