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

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ClinicalTrials.gov Identifier: NCT03655210
Recruitment Status : Completed
First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

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 Type : Interventional  (Clinical Trial)
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 : February 7, 2017
Actual Primary Completion Date : February 20, 2017
Actual Study Completion Date : October 16, 2017

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




Primary Outcome Measures :
  1. Changes in total rTNSS(Reflective TNSS) score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Visit 4 (4 weeks) ]
    Investigator's assessment of overall treatment



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03655210


Locations
Korea, Republic of
Seoul National University Hospital
Gyeonggi-do, Korea, Republic of, 13620
Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.

Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03655210     History of Changes
Other Study ID Numbers: HL_HL151_301
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
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
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salicylates
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action