Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

Q: What is the NCT07168473 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Q: Who can participate in NCT07168473?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07168473?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma (NCT07168473) is a Phase 3 interventional studying Perennial Allergic Rhinitis Accompanied by Asthma, sponsored by Daewon Pharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Perennial Allergic Rhinitis Accompanied by Asthma, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 274 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Perennial Allergic Rhinitis Accompanied by Asthma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: \<Screening Visit\> 1. Male or female adults aged 19 years or older. 2. Individuals with a confirmed history or treatment record of perennial allergic rhinitis for at least 2 years at the time of screening. 3. 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.). 4. Individuals diagnosed with asthma classified as Step 2 to Step 4. 5. Individuals who voluntarily provide written willing to sign a consent form to participate in this clinical trial. \<Randomization Visit\> 1. 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). 2. Subjects with medication compliance of ≥80% during the 7-day run-in period. Who Should NOT Join This Trial: \<A. Disease and Medical History-Related Exclusion Criteria\> 1. Individuals diagnosed with non-allergic rhinitis of other causes. 2. Individuals with a documented acute exacerbation of asthma within 12 weeks prior to screening. 3. Individuals diagnosed with pulmonary diseases other than asthma. 4. 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. 5. Individuals with nasal polyps or other clinically significant nasal structural abnormalities. 6. Individuals who have undergone nasal or perinasal surgery within 12 weeks prior to screening. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: \<Screening Visit\> 1. Male or female adults aged 19 years or older. 2. Individuals with a confirmed history or treatment record of perennial allergic rhinitis for at least 2 years at the time of screening. 3. 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.). 4. Individuals diagnosed with asthma classified as Step 2 to Step 4. 5. Individuals who voluntarily provide written informed consent to participate in this clinical trial. \<Randomization Visit\> 1. 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). 2. Subjects with medication compliance of ≥80% during the 7-day run-in period. Exclusion Criteria: \<A. Disease and Medical History-Related Exclusion Criteria\> 1. Individuals diagnosed with non-allergic rhinitis of other causes. 2. Individuals with a documented acute exacerbation of asthma within 12 weeks prior to screening. 3. Individuals diagnosed with pulmonary diseases other than asthma. 4. 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. 5. Individuals with nasal polyps or other clinically significant nasal structural abnormalities. 6. Individuals who have undergone nasal or perinasal surgery within 12 weeks prior to screening. 7. 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\> 1. Subjects who have initiated immunotherapy or changed the dosage within 4 weeks prior to the screening visit. 2. 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). 3. 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\> 1. Subjects with serum AST (GOT) or ALT (GPT) levels \> 2 × the upper limit of normal (ULN) based on screening test results. 2. Subjects with an estimated glomerular filtration rate (eGFR, calculated by CKD-EPI) \< 30 mL/min/1.73 m² based on screening test results.

Treatments Being Tested

DRUG

Experimental

1. DW1807 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks 2. DW1807-R2 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks

DRUG

Comparator

1. DW1807 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks 2. DW1807-R2 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Konkuk University Medical Center

Seoul, South Korea

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07168473), the sponsor (Daewon Pharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07168473 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07168473?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07168473?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07168473. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07168473. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.