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Completed

NCT Number: NCT03655210

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

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

Completed

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Hospital

Gyeonggi-do, 13620, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both gender, 19 years ≤ age
  • At least two years history of allergic rhinitis prior to participate in clinical trial
  • 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
  • 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)
  • Patients who can ability to record subject diary
  • Patients who agreed to maintain the same environment throughout the entire clinical trial period.
  • Written consent voluntarily to participate in this clinical trial after understanding and detailed explanation about this clinical trial

Exclusion criteria

  • Patients with non-allergic rhinitis
  • 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
  • Patients with obstructive nasal polyp or severe deviated nasal septum
  • Patients who Within 12 weeks from the date of screening, had damage or surgery around nasal cavity
  • Patients with anamnesis in acute /chronic sinusitis

Treatment and study plan

HL151

Drug

HL151(1Tab) once a day for 4 weeks of treatments

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hanlim Pharm. Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 31, 2018
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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