NCT07168473
Recruiting
Phase 3
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
Daewon Pharmaceutical Co., Ltd.1 site in 1 country274 target enrollmentStarted: September 9, 2024Last updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Enrollment
- 274
- Locations
- 1
- Primary Endpoint
- The mean change in reflective Total Nasal Symptom Score (rTNSS)
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Masking Description
Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •\<Screening Visit\>
- •Male or female adults aged 19 years or older.
- •Individuals with a confirmed history or treatment record of perennial allergic rhinitis for at least 2 years at the time of screening.
- •Individuals who have a positive result on an allergy skin prick test or serum allergen-specific IgE antibody test (e.g., MAST or ImmunoCAP) conducted within 1 year prior to screening, and have a documented history of allergy to at least one perennial allergen (e.g., house dust mites, cats, dogs, molds, etc.).
- •Individuals diagnosed with asthma classified as Step 2 to Step
- •Individuals who voluntarily provide written informed consent to participate in this clinical trial.
- •\<Randomization Visit\>
- •Subjects who meet all of the following criteria based on self-assessed nasal symptom scores recorded in the subject diary during the 7-day run-in period.
- •① Performed nasal symptom evaluations twice daily (morning and evening) on at least 4 days during the run-in period.
- •② Had an average daily Reflective Total Nasal Symptom Score (rTNSS) of ≥6 (maximum score: 12).
Exclusion Criteria
- •\<A. Disease and Medical History-Related Exclusion Criteria\>
- •Individuals diagnosed with non-allergic rhinitis of other causes.
- •Individuals with a documented acute exacerbation of asthma within 12 weeks prior to screening.
- •Individuals diagnosed with pulmonary diseases other than asthma.
- •Individuals diagnosed with the following types of sinusitis:
- •① Acute sinusitis within 4 weeks prior to screening.
- •② Clinically significant chronic sinusitis, as determined by the investigator.
- •Individuals with nasal polyps or other clinically significant nasal structural abnormalities.
- •Individuals who have undergone nasal or perinasal surgery within 12 weeks prior to screening.
- •Individuals with a documented upper respiratory tract infection (including the common cold) or systemic infection within 3 weeks prior to screening.
Arms & Interventions
Experimental
Experimental
DW1807 & DW1807-R2 placebo
Intervention: Experimental (Drug)
Comparator
Active Comparator
DW1807 placebo & DW1807-R2
Intervention: Comparator (Drug)
Outcomes
Primary Outcomes
The mean change in reflective Total Nasal Symptom Score (rTNSS)
Time Frame: During the last 2 weeks of the treatment period (i.e., Weeks 3 to 4 of investigational product administration
Secondary Outcomes
- The mean change from baseline in reflective Total Nasal Symptom Score (rTNSS)(During the first two weeks of the treatment period (Weeks 1 through 2 of investigational product administration).)
- The mean change from baseline in instantaneous Total Nasal Symptom Score (iTNSS)(During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.)
- The mean change from baseline in Daytime Nasal Symptom Score (DNSS)(During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.)
- The mean change from baseline in Nighttime Nasal Symptom Score (NNSS)(During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.)
- The mean change from baseline in Nighttime Symptom Score (NSS)(During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.)
- The mean change from baseline in [Insert Specific Symptom or Score](During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.)
- The Global Evaluation of Allergic Rhinitis (GEAR) assessed independently by both the investigator and the subject(At Week 4 of investigational product administration.)
Investigators
Study Sites (1)
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