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

• Sponsor: Hanlim Pharm. Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03655210
• Collaborator: (none)
• Enrollment: 272
• Location: 1
• Arms: 2
• Actual Duration (Months): 8.2
• Patients Per Site Per Month: 33

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Perennial Allergic Rhinitis	Drug: HL151; Drug: placebo	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 272 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: Double-blinded
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 7, 2017
• Actual Primary Completion Date: Feb 20, 2017
• Actual Study Completion Date: Oct 16, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

2. 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

3. 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

4. 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

5. Investigator's assessment of overall treatment [Visit 4 (4 weeks)]

   Investigator's assessment of overall treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

1. Patients with obstructive nasal polyp or severe deviated nasal septum

2. Patients who Within 12 weeks from the date of screening, had damage or surgery around nasal cavity

3. Patients with anamnesis in acute /chronic sinusitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Gyeonggi-do		Korea, Republic of	13620

Sponsors and Collaborators

• Hanlim Pharm. Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanlim Pharm. Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03655210
• Other Study ID Numbers: HL_HL151_301
• First Posted: Aug 31, 2018
• Last Update Posted: Aug 31, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial

Study Results

No Results Posted as of Aug 31, 2018