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

Hanlim Pharm

Status and phase: Completed; Phase 3

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: placebo; Drug: HL151

Study type: Interventional

Funder types: Industry

Identifiers

NCT03655210

HL_HL151_301

Details and patient eligibility

About

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

Full 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

Enrollment: 272 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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272 participants in 2 patient groups, including a placebo group

Experimental

Experimental group

Description:

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

Treatment:

Drug: HL151

Placebo Comparator

Placebo Comparator group

Description:

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

Treatment:

Drug: placebo