Asthma With Allergic RhinitisPhase 3NCT02552667
Efficacy and Safety of HCP1102 Capsule
A Phase 3 study of Asthma With Allergic Rhinitis, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
Efficacy and safety of HCP1102 capsule : 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
- Asthma With Allergic Rhinitis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Jul 2015
- 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
- Age≥15
- Mild or moderate asthma patients with allergic rhinitis
- Patient who meet all criteria of rhinitis
- Patients understood the contents and purpose of this trial and signed informed consent form
- Patients who are capable and willing to write subject diary
- Patients who agree with maintain same environment during clinical trials
Who cannot join
- Nonallergic rhinitis
- Severe asthma
- Other pulmonary disease (pulmonary tuberculosis, COPD) except Asthma
- Medical history of hypertrophic cardiomyopathy, cancer, renal disease, Liver disease, cardiovascular disease, respiratory disease, endocrine disorder, CNS disorder that effect safety
- Medical history of gastrointestinal surgery or gastrointestinal disorders that effect drug absorption
- Alcohol abuse or Drug abuse
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- Genetic factor of galactose intolerance or Lapp lactase deficiency or glucose-galactose malabsorption
- pregnant or breast-feeding women or men/women of childbearing age that they don't use contraceptives
- Patient who administered other investigational products within 30 days
- Current smoker Judged to be inappropriate for the study by the investigator after reviewing other reasons
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyunggi -do
About this study
Official title: Efficacy and Safety of HCP1102 Capsule : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
Efficacy and safety of HCP1102 capsule : A randomized, double-blind, active-controlled, multicenter phase 3 clinical trial.
- Conditions
- Asthma With Allergic Rhinitis
- Being tested
- HCP1102+HGP0711Placebo, HCP1102Placebo+HGP0711
- Keywords
- Asthma, Allergic rhinitis
- Medical subject headings
- Asthma, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP1102+HGP0711PlaceboDrug
Coadministration of HCP1102 with HGP0711 Placebo for 4-week
HCP1102Placebo+HGP0711Drug
Coadministration of HCP1102 Placebo with HGP0711 for 4-week
| Study group | Role | What they receive |
|---|---|---|
| HCP1102+HGP0711Placebo | Experimental | HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily Receives: Drug: HCP1102+HGP0711Placebo |
| HCP1102Placebo+HGP0711 | Active comparator | HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily Receives: Drug: HCP1102Placebo+HGP0711 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Mean Daytime Nasal Symptom Score
Measured: base line, 3-4week(2weeks)
Secondary outcomes (6)
Change of Mean Daytime Nasal Symptom Score
Measured: base line, 1-2week(2weeks), 3-4week(2weeks)
Change of Runny nose (Mean Daytime Nasal Symptom Score)
Measured: base line, 1-2week(2weeks), 3-4week(2weeks)
Change of Mean Nighttime Nasal Symptom Score
Measured: base line, 1-2week(2weeks), 3-4week(2weeks)
Change of Mean Composite Symptom Score
Measured: base line, 1-2week(2weeks), 3-4week(2weeks)
Change of sneezing (Mean Daytime Nasal Symptom Score)
Measured: base line, 1-2week(2weeks), 3-4week(2weeks)
Change of pruritus (Mean Daytime Nasal Symptom Score)
Measured: base line, 1-2week(2weeks), 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 posted17 Sep 2015 (estimated)
- Study startSep 2014
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma With 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
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Choon-Sik Park, M.D., Ph.D., Principal investigator, Soon Chun Hyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552667
- Sponsor's protocol ID
- HM-MOLZ-302
- Status last verified
- Sep 2015
- First submitted
- 7 Sep 2015
- Last updated
- 17 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim MK, Lee SY, Park HS, Yoon HJ, Kim SH, Cho YJ, Yoo KH, Lee SK, Kim HK, Park JW, Park HW, Chung JH, Choi BW, Lee BJ, Chang YS, Jo EJ, Lee SY, Cho YS, Jee YK, Lee JM, Jung J, Park CS. A Randomized, Multicenter, Double-blind, Phase III Study to Evaluate the Efficacy on Allergic Rhinitis and Safety of a Combination Therapy of Montelukast and Levocetirizine in Patients With Asthma and Allergic Rhinitis. Clin Ther. 2018 Jul;40(7):1096-1107.e1. doi: 10.1016/j.clinthera.2018.04.021. Epub 2018 Jun 24.
PubMed 29945738
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of HCP1102 Capsule : A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Clinical Trial
- ClinicalTrials.gov ID
- NCT02552667
- Acronym / sponsor ID
- HM-MOLZ-302
- Conditions
- Asthma With Allergic Rhinitis
- Keywords
- Asthma, Allergic rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 17 Sep 2015 (estimated)
- 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 capsule : 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+HGP0711Placebo | Experimental | Drug: HCP1102+HGP0711PlaceboHCP1102Placebo+HGP0711Placebo(1week) -> HCP1102+HGP0711Placebo(4weeks) Each 1 capsule, once daily |
| HCP1102Placebo+HGP0711 | Active comparator | Drug: HCP1102Placebo+HGP0711HCP1102Placebo+HGP0711Placebo(1week) -> HCP1102Placebo+HGP0711(4weeks) Each 1 capsule, once daily |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age≥15
- Mild or moderate asthma patients with allergic rhinitis
- Patient who meet all criteria of rhinitis
- Patients understood the contents and purpose of this trial and signed informed consent form
- Patients who are capable and willing to write subject diary
Key exclusion criteria (10 listed)
- Nonallergic rhinitis
- Severe asthma
- Other pulmonary disease (pulmonary tuberculosis, COPD) except Asthma
- Medical history of hypertrophic cardiomyopathy, cancer, renal disease, Liver disease, cardiovascular disease, respiratory disease, endocrine disorder, CNS disorder that effect safety
- Medical history of gastrointestinal surgery or gastrointestinal disorders that effect drug absorption
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 |
|---|---|---|
| HCP1102+HGP0711PlaceboCoadministration of HCP1102 with HGP0711 Placebo for 4-week | Drug | HCP1102+HGP0711Placebo |
| HCP1102Placebo+HGP0711Coadministration of HCP1102 Placebo with HGP0711 for 4-week | Drug | HCP1102Placebo+HGP0711 |
Primary outcome
Change of Mean Daytime Nasal Symptom Score
Time frame: base line, 3-4week(2weeks)
6 secondary outcomes
Change of Mean Daytime Nasal Symptom Score
Time frame: base line, 1-2week(2weeks), 3-4week(2weeks)
Change of Runny nose (Mean Daytime Nasal Symptom Score)
Time frame: base line, 1-2week(2weeks), 3-4week(2weeks)
Change of Mean Nighttime Nasal Symptom Score
Time frame: base line, 1-2week(2weeks), 3-4week(2weeks)
Change of Mean Composite Symptom Score
Time frame: base line, 1-2week(2weeks), 3-4week(2weeks)
Change of sneezing (Mean Daytime Nasal Symptom Score)
Time frame: base line, 1-2week(2weeks), 3-4week(2weeks)
Change of pruritus (Mean Daytime Nasal Symptom Score)
Time frame: base line, 1-2week(2weeks), 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 17 Sep 2015.
- Derived from this study: PubMed 29945738Kim MK, Lee SY, Park HS, Yoon HJ, Kim SH, Cho YJ, Yoo KH, Lee SK, Kim HK, Park JW, Park HW, Chung JH, Choi BW, Lee BJ, Chang YS, Jo EJ, Lee SY, Cho YS, Jee YK, Lee JM, Jung J, Park CS. A Randomized, Multicenter, Double-blind, Phase III Study to Evaluate the Efficacy on Allergic Rhinitis and Safety of a Combination Therapy of Montelukast and Levocetirizine in Patients With Asthma and Allergic Rhinitis. Clin Ther. 2018 Jul;40(7):1096-1107.e1. doi: 10.1016/j.clinthera.2018.04.021. Epub 2018 Jun 24.
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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.
Choon-Sik Park, M.D., Ph.D. principal investigator
Soon Chun Hyang University
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 of Asthma With 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 6 inclusion and 10 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 17 Sep 2015. 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?
On the ClinicalTrials.gov record for NCT02552667, which also lists 1 linked publication.
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 17 Sep 2015.