Back to resultsTo Evaluate the Efficacy and Safety of HL151 Versus Placebo in Perennial Allergic Rhinitis Patients
Primary Purpose
Perennial Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HL151
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental
Placebo Comparator
Arm Description
HL151(1Tab,Bepostatine salicylate) once a day, 4 weeks of treatment
HL151 Placebo (1Tab,Placebo of Bepostatine salicylate) once a day, 4 weeks of treatment
Outcomes
Primary Outcome Measures
Changes in total rTNSS(Reflective TNSS) score
Changes in total rTNSS(Reflective TNSS) score at 4 weeks after clinical drug administration compared to baseline
Secondary Outcome Measures
Changes in rTNSS(Reflective TNSS) score
Changes in rTNSS(Reflective TNSS) score at 2 weeks after clinical drug administration compared to baseline
Changes in iTNSS(Instananeous TNSS) score
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)
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)
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
Investigator's assessment of overall treatment
Full Information
NCT ID
NCT03655210
First Posted
August 28, 2018
Last Updated
August 29, 2018
Sponsor
Hanlim Pharm. Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03655210
Brief Title
To Evaluate the Efficacy and Safety of HL151 Versus Placebo in Perennial Allergic Rhinitis Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
February 7, 2017 (Actual)
Primary Completion Date
February 20, 2017 (Actual)
Study Completion Date
October 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanlim Pharm. Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blinded
Allocation
Randomized
Enrollment
272 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
HL151(1Tab,Bepostatine salicylate) once a day, 4 weeks of treatment
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
HL151 Placebo (1Tab,Placebo of Bepostatine salicylate) once a day, 4 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
HL151
Intervention Description
HL151(1Tab) once a day for 4 weeks of treatments
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
HL151 placebo(1Tab, Placebo of Bepostatine salicylate) once a day for 4 weeks of treatments
Primary Outcome Measure Information:
Title
Changes in total rTNSS(Reflective TNSS) score
Description
Changes in total rTNSS(Reflective TNSS) score at 4 weeks after clinical drug administration compared to baseline
Time Frame
Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
Secondary Outcome Measure Information:
Title
Changes in rTNSS(Reflective TNSS) score
Description
Changes in rTNSS(Reflective TNSS) score at 2 weeks after clinical drug administration compared to baseline
Time Frame
Visit 2 (0 week), Visit 3 (2 weeks)
Title
Changes in iTNSS(Instananeous TNSS) score
Description
Changes in iTNSS(Instananeous TNSS) score at 2 weeks and 4 weeks after clinical drug administration compared to baseline
Time Frame
Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
Title
Changes in rTNSS(Reflective TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy)
Description
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
Time Frame
Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
Title
Changes in iTNSS(Instananeous TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy)
Description
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
Time Frame
Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
Title
Investigator's assessment of overall treatment
Description
Investigator's assessment of overall treatment
Time Frame
Visit 4 (4 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Facility Information:
Facility Name
Seoul National University Hospital
City
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
To Evaluate the Efficacy and Safety of HL151 Versus Placebo in Perennial Allergic Rhinitis Patients
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