Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With … (NCT07168473) | Clinical Trial Compass
RecruitingPhase 3
Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma
South Korea274 participantsStarted 2024-09-09
Plain-language 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.
Who can participate
Age range19 Years
SexALL
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Inclusion criteria
✓. 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 4.
✓. Individuals who voluntarily provide written informed consent to participate in this clinical trial.
✓. 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.
✓. Subjects with medication compliance of ≥80% during the 7-day run-in period.
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:
What they're measuring
1
The mean change in reflective Total Nasal Symptom Score (rTNSS)
Timeframe: During the last 2 weeks of the treatment period (i.e., Weeks 3 to 4 of investigational product administration
. 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.
✕. Subjects who have initiated immunotherapy or changed the dosage within 4 weeks prior to the screening visit.