Perennial Allergic Rhinitis Accompanied by AsthmaPhase 3NCT07168473
Study to Evaluate the Efficacy and Safety of DW1807 in Perennial Allergic Rhinitis Patients With Asthma
A Phase 3 study testing Experimental and Comparator in people with Perennial Allergic Rhinitis Accompanied by Asthma, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis Accompanied by Asthma
- What is being tested?
- Experimental and Comparator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Sep 2024to 18 Sep 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <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.
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- <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.
Who cannot join
- <A. Disease and Medical History-Related 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:
- ① Acute sinusitis within 4 weeks prior to screening.
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- 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.
- <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).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Konkuk University Medical Center
Seoul
About this study
Official title: 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
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.
- Being tested
- Experimental, Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDrug
- DW1807 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks
- DW1807-R2 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks
ComparatorDrug
- DW1807 placebo Once daily with water regardless of meals without chewing or crushing for up to 4 weeks
- DW1807-R2 Once daily with water regardless of meals without chewing or crushing for up to 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | DW1807 \& DW1807-R2 placebo Receives: Drug: Experimental |
| Comparator | Active comparator | DW1807 placebo \& DW1807-R2 Receives: Drug: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean change in reflective Total Nasal Symptom Score (rTNSS)
Measured: During the last 2 weeks of the treatment period (i.e., Weeks 3 to 4 of investigational product administration
Secondary outcomes (7)
The mean change from baseline in reflective Total Nasal Symptom Score (rTNSS)
Measured: During the first two weeks of the treatment period (Weeks 1 through 2 of investigational product administration).
The mean change from baseline in instantaneous Total Nasal Symptom Score (iTNSS)
Measured: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
The mean change from baseline in Daytime Nasal Symptom Score (DNSS)
Measured: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
The mean change from baseline in Nighttime Nasal Symptom Score (NNSS)
Measured: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
The mean change from baseline in Nighttime Symptom Score (NSS)
Measured: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
The mean change from baseline in [Insert Specific Symptom or Score]
Measured: During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
The Global Evaluation of Allergic Rhinitis (GEAR) assessed independently by both the investigator and the subject
Measured: At Week 4 of investigational product administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start9 Sep 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion18 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic Rhinitis Accompanied by AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168473
- Sponsor's protocol ID
- DW1807-301
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No