Clinical trial NCT03655210: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Perennial Allergic Rhinitis
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-08-31
Enrollment: 272
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in total rTNSS(Reflective TNSS) score
timeFrame: Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
Secondary outcomes:
measure: Changes in rTNSS(Reflective TNSS) score
timeFrame: Visit 2 (0 week), Visit 3 (2 weeks)
measure: Changes in iTNSS(Instananeous TNSS) score
timeFrame: Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
measure: Changes in rTNSS(Reflective TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy)
timeFrame: Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
measure: Changes in iTNSS(Instananeous TNSS) score (Information recorded in the TNSS section of the diary included-Runny Nose,Sneezing,Itchy)
timeFrame: Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
measure: Investigator's assessment of overall treatment
timeFrame: Visit 4 (4 weeks)
Other outcomes:
Locations:
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: