Bronchial asthma
Conditions
Interventions
Single dose of Flutiform 125 Aerosol 2 puffs
Single dose of Symbicort Turbohaler 2 inhalations
Single dose of Relvar Ellipta single inhalationt
Sponsors
Tohno Chuo Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: <Visit 0> (1) Patients who were diagnosed as bronchial asthma. (2) Men or women aged >=20 and <80 years on the date of consent. (3) Patients who are able to change ICS/LABA to ICS with same titer. (4) Patients who are able to visit in the morning. (5) Patients who can voluntary provide consent with sufficient understanding of participation. <Visit 1> (1) Patients who provide consent based on the informed consent document. (2) Patients whose severity of asthma were mild persistent or moderate persistent by JGL2015. (3) Patients who were step 2 or 3 by JGL2015. (4) Patients' symptoms in current treatment are "Controlled" or "Mild intermittent". (5) ACQ <= 0.75. (6) No asthma exacerbation during three months.
Exclusion criteria
Exclusion criteria: <Visit 1> (1) Obvious COPD, ACO. (2) >=10 pack-years. (3) Patients who are not able to operate inhaler device. (4) Patients who used ICS/LABA or changed the dose of ICS during Run-in period. (5) Patients who inhaled Flutide Diskus before visit. (6) Chronic airway infection. (7) Patients who are complicated with severe liver, kidney and heart disease. (8) Patients who merger malignant tumor. (9) Patients who are pregnant or are likely to be pregnant. (10) Patients who are inadequate as the study subjects.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change of FEV1 from pre-dose FEV1 (3 minutes after inhalation) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Pulmonary function parameters Measured value at each evaluation point -Amount of change, change rate from pre-dose -AUC (change of amount from pre-dose) 2) Asthma control level -ACQ score -JACS score -Correlation between JACS and ACQ 3) Adverse Events | — |
Countries
Japan
Contacts
Public ContactHiroyuki Ohbayashi
Tohno Chuo Clinic Respiratory medicine
Outcome results
None listed