Bronchial Asthma
Conditions
Interventions
Flutiform (20 patients) Brand name: Flutiform125 Aerosol Moderate dose: 500 micrograms per day Study Period: 24 weeks Frequency: 2 inhalations per dose, 2 times per day
Relvar (20 patients)
Sponsors
Ikeda Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with bronchial asthma according to Japanese guideline for asthma (The Asthma Prevention and Management Guideline 2015) 2. Outpatients (men and women) at least 20 years of age who can give informed consent 3. Patients who have been using ICS monotherapy for at least 4 weeks prior to Visit 1, are insufficiently or poorly controlled on ICS monotherapy, and can switch to Flutiform or Relvar 4. Patients with severe persistent asthma and whose present treatment classifies as step 2 or step 3 according to the Asthma Prevention and Management Guideline 2015 (classification of asthma severity based on the present treatment) 5. Patients who are insufficiently or poorly controlled according to the Asthma Prevention and Management Guideline 2015
Exclusion criteria
Exclusion criteria: 1. Patients with evident ACO or COPD comorbidities 2. Patients with antibiotic-resistant infections, deep mycosis, or tuberculosis disease 3. Patients who have been afflicted with a respiratory infection (viral infection) within 8 weeks prior to enrollment 4. Patients with a smoking history of at least 10 pack years 5. Patients who have experienced side effects from the use of ICS, LABA or the combined medications 6. Patients who have used systemic steroids within 4 weeks prior to enrollment 7. Patients with significant heart, liver, kidney disease or other clinically significant comorbidities 8. Patients who are pregnant, breastfeeding, or plan to become pregnant during the study period 9. Other patients who are judged unsuitable for inclusion by the investigators in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Period until patients insufficiently or poorly controlled on ICS therapy are determined to be well-controlled by switching to ICS/LABA therapy Evaluation at 24 Week visit | — |
Secondary
| Measure | Time frame |
|---|---|
| -Pulmonary functions Evaluation at 0, 2, 8, 16, and 24 Week visit -symptoms During research period -peak flow meter During research period <Control level> -JGL Evaluation at 0 and 24 Week visit -ACQ Evaluation at 0, 2, 8, 16, and 24 Week visit -JACS Evaluation at 0, 2, 8, 16, and 24 Week visit -Simulation for the percentage of patients/period of time until patients become well-controlled using ACQ/JACS Evaluation at 0, 2, 8, 16, and 24 Week visit -Device operability questionnaire Evaluation at 0 and 24 Week visit -Correlation between control level and symptoms -Control level (ACQ/JACS) Evaluation at 0, 2, 8, 16, and 24 Week visit | — |
Countries
Japan
Contacts
Public ContactKenji Ikeda
Increase Co., Ltd. Clinical Development Department
Outcome results
None listed