bronchial asthma
Conditions
Interventions
Budesonide/Formoterol 160/4.5 mcg, one inhalation, twice daily
Sponsors
IAA Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with bronchial asthma who are at least 18 years of age at the time of consent 2. Patients who are able to understand the details of the study and who, at their own will, give written consent to participate in the study. 3. Patients, who in the opinion of the investigator, can comply with adherence to treatment, keep a patient diary, and perform peak flow measurements (morning and night) during the study period. 4. Patients who have continuously received given budesonide/formoterol (4 inhalations/day; BUD/FOR 640/18 mcg/day) therapy for at least the preceding 3 months 5. Patients with controlled asthma, as defined by the GINA classification, for at least the preceding 3 months. It should be noted that the control level at the commencement of the observation period may be assessed subjectively by the investigator as materials such as the patient diary may not always be available. In this study, the normal range for respiratory function was defined as any of the following: 1) %FEV1 >= 80% 2) FEV1 is >= 80% of personal best 3) Morning PEF is >= 80% of normal predicted value (in 1 week) 4) Morning PEF is >= 80% of personal best (in 1 week) 6. Patients whose ACQ5 score (survey regarding asthma management) is <= 0.75
Exclusion criteria
Exclusion criteria: 1. Smoking history: >= 10 packs/yr 2. Current smokers (including patients who quit smoking < 1mth) 3. Patients with any of the following lung diseases: COPD, bronchiectasis, lung cancer, collagen disease, pulmonary hypertension, tuberculosis sequelae, diffuse panbronchiolitis, interstitial pneumonia 4. Patients who were hospitalized due to asthma in the past year, who had an emergency presentation of asthma in the past 3 months, or who received an infusion of steroids due to worsening of asthma in the past 3 months. 5.Other patients judged by the physician to be inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Patients are classified into those who show aggravation of airway inflammation and those who do not after a dose reduction. A multivariate analysis is performed to identify the factors and parameters which account for the aggravation and increased eosinophil ratio (reflecting aggravation of airway inflammation) by evaluating patient demography prior to the dose reduction, absolute values of various parameters determined, and combinations thereof. 2) The correlation of sputum eosinophil count with FeNO level, ACQ score or GINA classification in asthma control is investigated. | — |
Countries
Japan
Contacts
Public ContactHiroaki Kume
Kinki University Faculty of Medicine Department of Respiratory Medicine and Allergology
Outcome results
None listed