RecruitingPhase 3NCT07168473

Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma

A Randomized, Double-blind, Active-controlled, Parallel, Multi-center, Phase 3 Trial to Compare and Evaluate the Efficacy and Safety of DW1807 and DW1807-R2 in Perennial Allergic Rhinitis Patients With Asthma


Sponsor

Daewon Pharmaceutical Co., Ltd.

Enrollment

274 participants

Start Date

Sep 9, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to compare the efficacy and safety of DW1807 and DW1807-R2 in patients with perennial allergic rhinitis and comorbid asthma. The primary objective is to demonstrate the superiority of DW1807 over DW1807-R2 in improving the reflective total nasal symptom score (rTNSS) after 4 weeks of treatment.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether DW1807, a new drug, can relieve symptoms of year-round (perennial) allergic rhinitis (chronic nasal allergies to things like dust mites, pets, or mold) in people who also have asthma. The goal is to see if DW1807 reduces sneezing, congestion, and runny nose better than existing options. **You may be eligible if...** - You are 19 years or older - You have had perennial allergic rhinitis for at least 2 years and have a confirmed allergy to year-round allergens (positive allergy test) - You also have asthma that is classified as moderately difficult to control (Step 2–4) - You are willing to provide written consent to participate **You may NOT be eligible if...** - You have only seasonal allergies (not year-round) - Your asthma is severe or uncontrolled - You have serious other medical conditions that could interfere with the study - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGExperimental

1. DW1807 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks 2. DW1807-R2 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks

DRUGComparator

1. DW1807 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks 2. DW1807-R2 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks


Locations(1)

Konkuk University Medical Center

Seoul, South Korea

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NCT07168473