bronchial asthma
Conditions
Interventions
Budesonide/Formoterol 160/4.5 mcg, two inhalations, twice a day
Sponsors
ESCORT Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [At start of observation period] (1) No changes in asthma treatment in the past two months (2) No prior treatment with ICSs, or current use of ICSs at doses basically not exceeding 200 mcg per day (400 mcg per day for budesonide) [At start of treatment period] "Partly controlled" or "uncontrolled" as defined by the GINA 2009 guidelines during the last week of observation period
Exclusion criteria
Exclusion criteria: (1) Use of oral, suppository, or intravenous corticosteroids, or long-acting beta 2-agonists (LABAs) for asthma within the past two months (2) Smoking history within the past six months (3) Any other concomitant pulmonary diseases, including COPD, bronchiectasis, lung cancer, collagen disease, pulmonary hypertension, late effects of tuberculosis, and diffuse panbronchiolitis (4) Contraindication to the study drug (5) Any other conditions which in the judgment of the investigator would make the patient inappropriate for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) Proportion of patients who achieved "controlled" according to the GINA 2009 guideline at weeks 8 and 12 of study treatment (2) Percent changes in lung function parameters (FEV1 and PEF) from week 0 to weeks 8 and 12 of study treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Changes in FeNO, PEF variability, FEV1, and each component of patient diary (2) Correlations between the variables assessed and their time profile (3) Adverse events | — |
Countries
Japan
Contacts
Public ContactMasakazu Ichinose
Wakayama Medical University Third Department of Internal Medicine
Outcome results
None listed