Perennial Allergic Rhinitis
Conditions
Brief summary
4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial
Detailed description
4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial to Evaluate the Efficacy and Safety of HL151 versus Placebo in perennial allergic rhinitis patients
Interventions
DRUGHL151
HL151(1Tab) once a day for 4 weeks of treatments
DRUGplacebo
HL151 placebo(1Tab, Placebo of Bepostatine salicylate) once a day for 4 weeks of treatments
Sponsors
Hanlim Pharm. Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double-blinded
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Both gender, 19 years ≤ age 2. At least two years history of allergic rhinitis prior to participate in clinical trial 3. Patients with positive reaction for perennial allergen in tests(prick test or Intradermal test or MAST(Multiple Allergen Simultaneous Test) or Immuno CAP test) within 12 months 4. In visit 2, patients with over mean 5 points of the total reflective TNSS score per day (during the run-in period) (highest value 12 points) 5. Patients who can ability to record subject diary 6. Patients who agreed to maintain the same environment throughout the entire clinical trial period. 7. Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial
Exclusion criteria
1. Patients with non-allergic rhinitis 2. Patients with asthma due to the following diseases(but patients with mild and intermittent asthma are available to participate in clinical trials) * Within four weeks from the date of screening, patients who visit the emergency room or have been hospitalized within 12 weeks or * patients with asthma who need other treatment except short-acting Beta-efficient respiratory relaxants Inhalation 3. Patients with obstructive nasal polyp or severe deviated nasal septum 4. Patients who Within 12 weeks from the date of screening, had damage or surgery around nasal cavity 5. Patients with anamnesis in acute /chronic sinusitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in total rTNSS(Reflective TNSS) score | Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks) | Changes in total rTNSS(Reflective TNSS) score at 4 weeks after clinical drug administration compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in rTNSS(Reflective TNSS) score | Visit 2 (0 week), Visit 3 (2 weeks) | Changes in rTNSS(Reflective TNSS) score at 2 weeks after clinical drug administration compared to baseline |
| Changes in iTNSS(Instananeous TNSS) score | Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks) | Changes in iTNSS(Instananeous TNSS) score at 2 weeks and 4 weeks after clinical drug administration compared to baseline |
| Changes in rTNSS(Reflective TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy) | Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks) | Changes in rTNSS(Reflective TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy) at 2 weeks and 4 weeks after clinical drug administration compared to baseline |
| Changes in iTNSS(Instananeous TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy) | Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks) | Changes in iTNSS(Instananeous TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy) at 2 weeks and 4 weeks after clinical drug administration compared to baseline |
| Investigator's assessment of overall treatment | Visit 4 (4 weeks) | Investigator's assessment of overall treatment |
Countries
South Korea
Outcome results
None listed