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

Korábbi kezelés

• Individuals with a documented acute exacerbation of asthma within 12 weeks prior to screening.
• 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 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.
  • <B. Concomitant Medication Use>
• Subjects who have initiated immunotherapy or changed the dosage within 4 weeks prior to the screening visit.
• Subjects who are on chronic use of medications that, in the opinion of the investigator, may interfere with the assessment of the investigational product's efficacy (e.g., tricyclic antidepressants).

Más betegség

• <A. Disease and Medical History-Related Exclusion Criteria>
• Individuals diagnosed with non-allergic rhinitis of other causes.
• Individuals diagnosed with pulmonary diseases other than asthma.

Laborértékek

• Subjects who are currently taking, or are expected to require during the study, any medications that are prohibited as per the protocol.
  • <C. Laboratory Criteria>
• Subjects with serum AST (GOT) or ALT (GPT) levels > 2 × the upper limit of normal (ULN) based on screening test results.
• Subjects with an estimated glomerular filtration rate (eGFR, calculated by CKD-EPI) < 30 mL/min/1.73 m² based on screening test results.

Egyéb

• Individuals with nasal polyps or other clinically significant nasal structural abnormalities.

• <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 4.
• 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).
• Subjects with medication compliance of ≥80% during the 7-day run-in period.