To Evaluate the Efficacy and Safety of HL151 Versus Placebo in Perennial Allergic Rhinitis Patients
- Registration Number
- NCT03655210
- Lead Sponsor
- Hanlim Pharm. Co., Ltd.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
- Both gender, 19 years ≤ age
- At least two years history of allergic rhinitis prior to participate in clinical trial
- 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
- 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)
- Patients who can ability to record subject diary
- Patients who agreed to maintain the same environment throughout the entire clinical trial period.
- Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial
-
Patients with non-allergic rhinitis
-
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
-
Patients with obstructive nasal polyp or severe deviated nasal septum
-
Patients who Within 12 weeks from the date of screening, had damage or surgery around nasal cavity
-
Patients with anamnesis in acute /chronic sinusitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental HL151 HL151(1Tab,Bepostatine salicylate) once a day, 4 weeks of treatment Placebo Comparator placebo HL151 Placebo (1Tab,Placebo of Bepostatine salicylate) once a day, 4 weeks of treatment
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Gyeonggi-do, Korea, Republic of