Perennial Allergic RhinitisNCT04654702
Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap.
An observational study of Perennial Allergic Rhinitis and Asthma, run by Hanmi Pharmaceutical Company Limited at 1 site in South Korea.
Trial summary
Investigator examines the past prescription patterns and the reasons for the change of prescription to Monterizine capsules for Perennial Allergic Rhinitis patients with Asthma who will be taking Monterizine capsules to treat allergic rhinitis. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis, Asthma
- How many people
- 2,671 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Nov 2017to 20 Jul 2020
- Phase
- Observational
- 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
Study population: 3,000 patients
Who may be able to join
- Male or female aged ≥ 15 years
- Perennial allergic rhinitis patients with asthma who will be prescribed Monterizine capsules to treat allergic rhinitis
- Patients who provided a signed written informed consent form
Who cannot join
- Highly sensitive patients to ingredients of Monterizine capsules, hydroxyzine or piperazine derivatives
- Patients with renal failure(CLCR,10ml/min) and hemodialysis patients
- A female who is pregnant, may be pregnant, or is lactating
- Patients with genetic problems like Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
Trial locations and contacts
1 site in 1 country.
South Korea1 site
59 institutions including Chung-Ang University Hospital
Seoul
About this study
Official title: A Multi-center, Prospective, Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap in Patients With Asthma and Perennial Allergic Rhinitis.
Investigator examines the past prescription patterns and the reasons for the change of prescription to Monterizine capsules for Perennial Allergic Rhinitis patients with Asthma who will be taking Monterizine capsules to treat allergic rhinitis.
After being given Monterizine capsules, Investigator evaluates the therapeutic effectiveness and safety for 3 months (or 6 months).
Read the detailed description
A Multi-center, Prospective, Observational Study
- Conditions
- Perennial Allergic Rhinitis, Asthma
- Medical subject headings
- Rhinitis, Allergic, Perennial, Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline
The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline.
*TNSS: Total symptom scores for nasal congestion, sneezing, runny nose and nasal itching during the daytime in the past week
Measured: 3 Month
Secondary outcomes (5)
The change in the average of TNSS at the point of Period 2(recommended 6Month(±1Month)) as compared to baseline
The change in the average of TNSS at the point of Period 2(recommended 6Month(±1Month)) as compared to baseline
Measured: 6Month
The change in the therapeutic satisfaction at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline
The change in the therapeutic satisfaction at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(1±Month)) as compared to baseline.
*Therapeutic satisfaction : overall satisfaction with the treatment of allergic rhinitis for the past month. A possible scale is then: "Very Satisfied", "Satisfied", "Neutral", "Dissafistied", "Very Dissatisfied"
Measured: 3Month,6Month
The change in the quality of life at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline
The change in the quality of life at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline.
*Evaluate the quality of life with KARQLQ (Korean allergic rhinitis-specific quality of life questionnaire: 10 questions in regular activities at home and work, daily life disturbance and other symptoms)in the past week.
Measured: 3Month,6Month
The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline
The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline.
*Assessing the medication compliance for the last 30 days; compliance⪴80%, non-compliance<20%
Measured: 3Month,6Month
Occurrence and frequency of adverse events
Occurrence and frequency of adverse events
Measured: 6Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start17 Nov 2017
- Primary completion10 Jan 2020
- Study completion20 Jul 2020
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,671 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byoung-Whui Choi, Principal investigator, 59 institutions including Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04654702
- Sponsor's protocol ID
- HM-MONT-OS-01
- Status last verified
- Nov 2021
- First submitted
- 17 Nov 2020
- Last updated
- 26 Nov 2021
- 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 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Observational Study to Evaluate Therapeutic Effectiveness and Safety of Monterizine Cap in Patients With Asthma and Perennial Allergic Rhinitis.
- ClinicalTrials.gov ID
- NCT04654702
- Acronym / sponsor ID
- HM-MONT-OS-01
- Conditions
- Perennial Allergic Rhinitis, Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,671 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 20 Jul 2020 (actual)
- First posted
- 4 Dec 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.
Investigator examines the past prescription patterns and the reasons for the change of prescription to Monterizine capsules for Perennial Allergic Rhinitis patients with Asthma who will be taking Monterizine capsules to treat allergic rhinitis.
After being given Monterizine capsules, Investigator evaluates the therapeutic effectiveness and safety for 3 months (or 6 months).
Detailed description
A Multi-center, Prospective, Observational Study
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 3,000 patients
Key inclusion criteria (3 listed)
- Male or female aged ≥ 15 years
- Perennial allergic rhinitis patients with asthma who will be prescribed Monterizine capsules to treat allergic rhinitis
- Patients who provided a signed written informed consent form
Key exclusion criteria (4 listed)
- Highly sensitive patients to ingredients of Monterizine capsules, hydroxyzine or piperazine derivatives
- Patients with renal failure(CLCR,10ml/min) and hemodialysis patients
- A female who is pregnant, may be pregnant, or is lactating
- Patients with genetic problems like Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline
Time frame: 3 Month
The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline. *TNSS: Total symptom scores for nasal congestion, sneezing, runny nose and nasal itching during the daytime in the past week
5 secondary outcomes
The change in the average of TNSS at the point of Period 2(recommended 6Month(±1Month)) as compared to baseline
Time frame: 6Month
The change in the therapeutic satisfaction at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline
Time frame: 3Month,6Month
The change in the quality of life at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline
Time frame: 3Month,6Month
The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline
Time frame: 3Month,6Month
Occurrence and frequency of adverse events
Time frame: 6Month
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 26 Nov 2021.
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Study of CM512 Injection in Patients With Perennial Allergic Rhinitis on Background Therapy
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RecruitingObservational study
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A Study to Visualize Multi-Symptom Allergy in Adults With Seasonal Allergic Rhinitis
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Dupilumab Effects Against Aeroallergen Challenge
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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.
Byoung-Whui Choi principal investigator
59 institutions including Chung-Ang University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perennial Allergic Rhinitis and Asthma, 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 3 inclusion and 4 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 26 Nov 2021. 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.
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?
The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline (time frame: 3 Month). 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 26 Nov 2021.