Perennial Allergic RhinitisPhase 3NCT04324918
Efficacy and Safety of HCP1102 Capsule in Patients With Perennial Allergic Rhinitis
A Phase 3 study testing HCP1102 and HGP1408 in people with Perennial Allergic Rhinitis, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- HCP1102 and HGP1408
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Oct 2018to 24 Jun 2019
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with at least 2 years history of PAR prior to the study
- Positive results of skin prick test
- Patients who provided a signed written informed consent form
- Patients who are able and willing to complete subject diaries
- Patients who agree to maintain consistency in their surroundings throughout the study period
Who cannot join
- Patients also with non-allergic rhinitis with different causes.
- Patients with severe asthma.
- History of acute • chronic sinusitis within 1 month of Visit 1
- History of intranasal surgeries within 3 months of Visit 1
- Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
- Upper respiratory infections including cold and systemic infections within 3 weeks of Visit 1.
- Chronic use of tricyclic antidepressants, beta agonists, bronchodilators, etc. that may affect the efficacy of study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of HCP1102 in Patients With Perennial Allergic Rhinitis : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis :
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- HCP1102, HGP1408
- 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.
HCP1102Drug
The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.
HGP1408Drug
The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.
| Study group | Role | What they receive |
|---|---|---|
| HCP1102 | Experimental | Not described Receives: Drug: HCP1102 |
| HGP1408 | Active comparator | Not described Receives: Drug: HGP1408 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Mean Daytime Nasal Symptom Score
Daytime nasal symptoms included rhinorrhea, nasal obstruction, sneezing, and itching, each scored from 0 to 3 (0 = none, 1 = mild, 2 = moderate and 3 = severe).
Measured: base line, 3-4week(2weeks)
Secondary outcomes (1)
Change of Mean Nighttime Nasal Symptom Score
Nighttime nasal symptoms included nasal obstruction awakening (0 = none; 1 = mild; 2 = moderate; 3 = severe), difficulty getting to sleep (0 = not at all; 1 = little; 2 = moderate; 3 = severe), and nighttime awakening (0 = not at all; 1 = once; 2 = more than once; 3 = awake all night).
Measured: baseline, 3-4week(2weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start23 Oct 2018
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
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.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyung-Su Kim, M.D., Ph.D., Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324918
- Sponsor's protocol ID
- HM-MOLZ-303
- Status last verified
- Mar 2020
- First submitted
- 4 Feb 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HCP1102 in Patients With Perennial Allergic Rhinitis : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
- ClinicalTrials.gov ID
- NCT04324918
- Acronym / sponsor ID
- HM-MOLZ-303
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 27 Mar 2020 (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.
Efficacy and safety of HCP1102 in patients with perennial allergic rhinitis :
A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCP1102 | Experimental | Drug: HCP1102 |
| HGP1408 | Active comparator | Drug: HGP1408 |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with at least 2 years history of PAR prior to the study
- Positive results of skin prick test
- Patients who provided a signed written informed consent form
- Patients who are able and willing to complete subject diaries
- Patients who agree to maintain consistency in their surroundings throughout the study period
Key exclusion criteria (7 listed)
- Patients also with non-allergic rhinitis with different causes.
- Patients with severe asthma.
- History of acute • chronic sinusitis within 1 month of Visit 1
- History of intranasal surgeries within 3 months of Visit 1
- Initiation of immunotherapy or dose modification within 1 month prior to Visit 1
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 |
|---|---|---|
| HCP1102The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks. | Drug | HCP1102 |
| HGP1408The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks. | Drug | HGP1408 |
Primary outcome
Change of Mean Daytime Nasal Symptom Score
Time frame: base line, 3-4week(2weeks)
Daytime nasal symptoms included rhinorrhea, nasal obstruction, sneezing, and itching, each scored from 0 to 3 (0 = none, 1 = mild, 2 = moderate and 3 = severe).
1 secondary outcome
Change of Mean Nighttime Nasal Symptom Score
Time frame: baseline, 3-4week(2weeks)
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 27 Mar 2020.
Related trials for Perennial Allergic Rhinitis
Active, not recruitingPhase 3
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Perennial Allergic Rhinitis (PAR)
Not yet recruitingPhase 2
Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
Perennial Allergic Rhinitis (PAR)
RecruitingObservational study
Identification of B Regulatory Cells by Flow Cytometry
Pollen Allergy, Venom Allergy
Not yet recruitingPhase 4
A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
Rhinitis Allergic, Rhinitis Seasonal
Active, not recruitingPhase 2
Dupilumab Effects Against Aeroallergen Challenge
Asthma, Allergic
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.
Kyung-Su Kim, M.D., Ph.D. principal investigator
Gangnam Severance Hospital
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 HCP1102 and HGP1408 in people with Perennial Allergic Rhinitis, run by Hanmi Pharmaceutical Company Limited 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 5 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 27 Mar 2020. 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. 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?
Change of Mean Daytime Nasal Symptom Score (time frame: base line, 3-4week(2weeks)). 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 27 Mar 2020.