Asthma, Perennial Allergic Rhinitis
Conditions
Brief 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. 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
Interventions
None listed
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female aged ≥ 15 years 2. Perennial allergic rhinitis patients with asthma who will be prescribed Monterizine capsules to treat allergic rhinitis 3. Patients who provided a signed written informed consent form
Exclusion criteria
1. Highly sensitive patients to ingredients of Monterizine capsules, hydroxyzine or piperazine derivatives 2. Patients with renal failure(CLCR,10ml/min) and hemodialysis patients 3. A female who is pregnant, may be pregnant, or is lactating 4. Patients with genetic problems like Galactose intolerance, Lapp lactase deficiency or Glucose-galactose malabsorption
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change in the average of TNSS at the point of Period 1 (recommended 3 Month(-1 Month)) as compared to baseline | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change in the average of TNSS at the point of Period 2(recommended 6Month(±1Month)) as compared to baseline | 6Month | The change in the average of TNSS at the point of 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(±1Month)) as compared to baseline | 3Month,6Month | 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 |
| 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 | 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. \*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. |
| The change in the medication compliance at the point of Period 1 (recommended 3Month(-1Month)), Period 2(recommended 6Month(±1Month)) as compared to baseline | 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. \*Assessing the medication compliance for the last 30 days; compliance⪴80%, non-compliance\<20% |
| Occurrence and frequency of adverse events | 6Month | Occurrence and frequency of adverse events |
Countries
South Korea
Outcome results
None listed