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Tests treatment safety and results for Perennial Allergic Rhinitis Accompanied by Asthma
Official title Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma
ClinicalTrials.gov ID: NCT07168473
What this study is testing
What is Experimental?
Experimental is an investigational medicine, given as an once-daily, being studied as a potential treatment for perennial allergic rhinitis accompanied by asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older
You may be able to join if
- 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...
- Individuals diagnosed with asthma classified as Step 2 to Step 4.
- Individuals who voluntarily provide written informed consent to participate in this clinical trial. \
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- Individuals diagnosed with asthma classified as Step 2 to Step 4.
- Individuals who voluntarily provide written informed consent to participate in this clinical trial. \
- people 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...
- people with medication compliance of ≥80% during the 7-day run-in period.
- 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. \
- people who have initiated immunotherapy or changed the dosage within 4 weeks prior to the screening visit.
- people who are on chronic use of medications that, in the opinion of the investigator, may interfere with the assessment of the investigational product's how well it works (e.g., tricyclic antidepressants).
- people who are currently taking, or are expected to require during the study, any medications that are prohibited as per the protocol. \
- people with serum AST (GOT) or ALT (GPT) levels \> 2 × the upper limit of normal (ULN) based on screening test results.
- people with an estimated glomerular filtration rate (eGFR, calculated by CKD-EPI) \< 30 mL/min/1.73 m² based on screening test results.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.