Inadequately controlled asthma
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adolescent or adult patients with asthma who met the GINA guidelines diagnostic criteria of 12 years of age or older. Patients with moderate to severe persistent asthma who receive 200uL/day fluticasone or equivalent or more inhaled corticosteroid (ICS) with episode of at least once clinically significant (requiring administered with systemic steroids, or requiring consultation to an emergency outpatient or admission. FEV1.0 before bronchodilator administration is less than 80% (adolescent with less than 90% is acceptable).FEV1.0 reversibility after administration of short acting beta-2 agonist (SABA) is 12% or more, or 200 ml or more.The ACQ-6 score before inclusion is 1.5 or more.
Exclusion criteria
Exclusion criteria: The exclusion criteria was patients under 12 years of age, current smokers, or COPD patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| annualized exacerbation rate | — |
Secondary
| Measure | Time frame |
|---|---|
| change in FEV1.0 from baseline change in AQLQ fron baseline any adverse events any serious adverse events death caused by adverse events | — |
Countries
Japan
Contacts
Showa University Division of Respiratory Medicine and Allergology, Department of Medicine