Health TrialsbyHealthPanel

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

ConditionPerennial Allergic Rhinitis Accompanied by 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Experimental

    Drug

    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

  • Comparator

    Drug

    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

Treatment groups

274 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 1 intervention
Group B: ComparatorActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The mean change in reflective Total Nasal Symptom Score (rTNSS)

Time frame
During the last 2 weeks of the treatment period (i.e., Weeks 3 to 4 of investigational product administration

Secondary outcomes

1

The mean change from baseline in reflective Total Nasal Symptom Score (rTNSS)

Time frame
During the first two weeks of the treatment period (Weeks 1 through 2 of investigational product administration).
2

The mean change from baseline in instantaneous Total Nasal Symptom Score (iTNSS)

Time frame
During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
3

The mean change from baseline in Daytime Nasal Symptom Score (DNSS)

Time frame
During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.
4

The mean change from baseline in Nighttime Nasal Symptom Score (NNSS)

Time frame
During both the first two weeks (Weeks 1 through 2) and the final two weeks (Weeks 3 through 4) of the treatment period.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Daewon Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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