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

NCT03655210 | Completed Phase 3

• 1 other identifier: HL_HL151_301
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Perennial Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Changes in rTNSS(Reflective TNSS) score

  Visit 2 (0 week), Visit 3 (2 weeks)

• Changes in iTNSS(Instananeous TNSS) score

  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)

  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)

  Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)

• Investigator's assessment of overall treatment

  Visit 4 (4 weeks)

Study Arms (2)

Experimental

EXPERIMENTAL

HL151(1Tab,Bepostatine salicylate) once a day, 4 weeks of treatment

Drug: HL151

Placebo Comparator

PLACEBO COMPARATOR

HL151 Placebo (1Tab,Placebo of Bepostatine salicylate) once a day, 4 weeks of treatment

Drug: placebo

Interventions

HL151 DRUG

HL151(1Tab) once a day for 4 weeks of treatments

Experimental

placebo DRUG

HL151 placebo(1Tab, Placebo of Bepostatine salicylate) once a day for 4 weeks of treatments

Placebo Comparator

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanlim Pharm. Co., Ltd.: lead

Study Sites (1)

Seoul National University Hospital

Gyeonggi-do, 13620, South Korea

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: February 7, 2017
• Primary Completion: February 20, 2017
• Study Completion: October 16, 2017
• Last Updated: August 31, 2018

Record last verified: 2018-08

Locations

KR (1)