Bronchial asthma
Conditions
Interventions
<
Observation period>
Medium dose of ICS/LABA combination (dry powders) for 4 weeks <
Treatment period>
High dose of Flutiform&
reg
(4 puff twice daily) for 8 weeks
<
High of pretreatment drug for 8 weeks
Sponsors
Dokkyo Medical University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: <Observation period> (1) Adult patients with asthma (2) Outpatients (3) Those who are receiving Step-3 treatment in accordance with the "asthma prevention and management guideline 2012 (JGL2012)" (4) Those who have been treated with ICS/LABA (medium doses, DPI formulation) for more than 4 weeks (5) Patients with severe persistent asthma according to the "severity classification based on current treatment" of the JGL2012 (6) Those who understand an explanation about the present study and can give written informed consent *Those who fulfill the inclusion criteria above and have been treated without a dose change during the 4 weeks before informed consent are allowed to immediately enter the treatment period. <Treatment period> Those who fulfill the criteria below at the end of the observation period can enter the treatment period. (1) Those who are receiving Step-3 treatment in accordance with the JGL2012 (2) Patients with severe persistent asthma according to the "severity classification based on current treatment" of the JGL2012 (3) Those who were treated without a dose change during the observation period
Exclusion criteria
Exclusion criteria: (1) Patients with COPD (2) Patients who take SABA other than treatment of exacerbations (3) Patients who had a history of adverse reaction to ICS or LABA (4) Patients who took flutiform &reg; within four weeks (5) Patients with severe cardiac, hepatic, renal, pulmonary, or hematologic disease (6) Current malignancy (7) Smoking within past 1 year (8) Those who are pregnant, under-lactation, or desire pregnancy (9) Unsuitability as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Asthma control questionnaire (ACQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function tests (FEV1, %FEV1, FEV1%, V25, V50), FeNO, IOS indices (R5, R20, R5-R20, X5, Ax), the number of times rescue medications are used (oral steroids, infusion (steroids/aminophylline), SABA) | — |
Countries
Japan
Contacts
Public ContactMori Nobuhide
Research Administration Office (Mebix, Inc.) Research Promotion Office
Outcome results
None listed