Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age19+
SponsorDaewon Pharmaceutical Co., Ltd.
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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 with nasal polyps or other clinically significant nasal structural abnormalities.
Trial design
Treatments tested in this trial
- Experimental
- Comparator
Treatment groups
274 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov