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

Perennial Allergic Rhinitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03655210
• Other study ID #: HL_HL151_301
• Status: Completed
• Phase: Phase 3
• Start date: February 7, 2017
• Est. completion date: October 16, 2017

Study information

• Verified date: August 2018
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: October 16, 2017
• Est. primary completion date: February 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Perennial Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Perennial

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Investigator's assessment of overall treatment	Investigator's assessment of overall treatment	Visit 4 (4 weeks)