To Evaluate the Efficacy and Safety of HL151 Versus Placebo in Perennial Allergic Rhinitis Patients

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

4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial

Study Overview

• Status: Completed
• Conditions: Perennial Allergic Rhinitis
• Intervention / Treatment: Drug: HL151; Drug: placebo

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

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental; HL151(1Tab,Bepostatine salicylate) once a day, 4 weeks of treatment	Drug: HL151; HL151(1Tab) once a day for 4 weeks of treatments
PLACEBO_COMPARATOR: Placebo Comparator; HL151 Placebo (1Tab,Placebo of Bepostatine salicylate) once a day, 4 weeks of treatment	Drug: placebo; HL151 placebo(1Tab, Placebo of Bepostatine salicylate) once a day for 4 weeks of treatments

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in total rTNSS(Reflective TNSS) score	Changes in total rTNSS(Reflective TNSS) score at 4 weeks after clinical drug administration compared to baseline	Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in rTNSS(Reflective TNSS) score	Changes in rTNSS(Reflective TNSS) score at 2 weeks after clinical drug administration compared to baseline	Visit 2 (0 week), Visit 3 (2 weeks)
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	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)	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	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)	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	Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
Investigator's assessment of overall treatment	Investigator's assessment of overall treatment	Visit 4 (4 weeks)

Collaborators and Investigators

• Sponsor: Hanlim Pharm. Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 7, 2017
• Primary Completion (ACTUAL): February 20, 2017
• Study Completion (ACTUAL): October 16, 2017

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (ACTUAL): August 31, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: HL_HL151_301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No