Perennial Allergic RhinitisPhase 3NCT03655210
To Evaluate the Efficacy and Safety of HL151 Versus Placebo in Perennial Allergic Rhinitis Patients
A Phase 3 study testing HL151 in people with Perennial Allergic Rhinitis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
Trial summary
4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- HL151
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 272 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Feb 2017to 16 Oct 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
4week, a Multicenter, Randomized, Double-blinded, Parallel, Therapeutic confirmatory Clinical Trial
Read the 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
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- HL151, placebo
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HL151Drug
HL151(1Tab) once a day for 4 weeks of treatments
placeboDrug
HL151 placebo(1Tab, Placebo of Bepostatine salicylate) once a day for 4 weeks of treatments
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | HL151(1Tab,Bepostatine salicylate) once a day, 4 weeks of treatment Receives: Drug: HL151 |
| Placebo Comparator | Placebo comparator | HL151 Placebo (1Tab,Placebo of Bepostatine salicylate) once a day, 4 weeks of treatment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in total rTNSS(Reflective TNSS) score
Changes in total rTNSS(Reflective TNSS) score at 4 weeks after clinical drug administration compared to baseline
Measured: Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
Secondary outcomes (5)
Changes in rTNSS(Reflective TNSS) score
Changes in rTNSS(Reflective TNSS) score at 2 weeks after clinical drug administration compared to baseline
Measured: Visit 2 (0 week), Visit 3 (2 weeks)
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
Measured: 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)
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
Measured: 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)
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
Measured: Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
Investigator's assessment of overall treatment
Investigator's assessment of overall treatment
Measured: Visit 4 (4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start7 Feb 2017
- Primary completion20 Feb 2017
- Study completion16 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanlim Pharm. Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03655210
- Sponsor's protocol ID
- HL_HL151_301
- Status last verified
- Aug 2018
- First submitted
- 28 Aug 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03655210
- Acronym / sponsor ID
- HL_HL151_301
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Hanlim Pharm. Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: HL151HL151(1Tab,Bepostatine salicylate) once a day, 4 weeks of treatment |
| Placebo Comparator | Placebo comparator | Drug: placeboHL151 Placebo (1Tab,Placebo of Bepostatine salicylate) once a day, 4 weeks of treatment |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HL151HL151(1Tab) once a day for 4 weeks of treatments | Drug | Experimental |
| placeboHL151 placebo(1Tab, Placebo of Bepostatine salicylate) once a day for 4 weeks of treatments | Drug | Placebo Comparator |
Primary outcome
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
5 secondary outcomes
Changes in rTNSS(Reflective TNSS) score
Time frame: Visit 2 (0 week), Visit 3 (2 weeks)
Changes in iTNSS(Instananeous TNSS) score
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)
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)
Time frame: Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)
Investigator's assessment of overall treatment
Time frame: Visit 4 (4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HL151 in people with Perennial Allergic Rhinitis, run by Hanlim Pharm. Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in total rTNSS(Reflective TNSS) score (time frame: Visit 2 (0 week), Visit 3 (2 weeks), Visit 4 (4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2018.