Bronchial Asthma
Conditions
Interventions
Budesonide/formoterol group Symbicort Turbuhaler 160/4.5ug two inhalations, twice daily for 12 weeks
Budesonid + turobuterol-patch group Pulmicort Turbuhaler 200ug two inhalations, twice daily + t
Sponsors
Second Department of Internal Medicine, Nagasaki University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Signed informed consent 2) Outpatients over 65 years old with asthma 3) Who have been using Adoair 50/100ug or 50/250ug one inhalation twice daily or ICS (low or moderate dose) at least for over 4 weeks 4) ACQ > 0.75 or %FEV1pred < 80%
Exclusion criteria
Exclusion criteria: 1) Patients with a history of hypersensitivity(e.g contact dermatitis) to any ingredient contained in the budesonide/formoterol combination 2) Patients with a history of hypersensitivity to any ingredient contained in the tulobuterol-patch 3) Patients with infectious with no availabl effective antimicrobial drugs or with deep-seated mycosis 4) Patients with other respiratory illnesses(lung cancer, tuberculosis, bronchiectasis etc) 5) Patients with heart failure 6) Patients with RE 7) %FEV1<60% 8) Patients who contracted a respiratory infection that could influence asthma within the last 4 weeks 9) Patients who were treated with systemic corticosteroids in the last 4 weeks 10) Patients who are taking high-dose ICS 11) Patients who are taking PSL 12) Patients who are taking inhaled anticholinergic drugs 13) Patients who are treated with ZOREA(omalizumab) 14) Patients with other severe diseases 15) Patients who are considered inappropriate by the physician in charge
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in the ACQ(asthma control questionnaire) score after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of various indicator as follow 1) Fraction of exhaled Nitric Oxide 2) Lung function(FEV1.0 etc) 3) Asthma relevant QOL (miniAQLQ score) 4) Night-time awaking due to asthma 5) Symptom-free days | — |
Countries
Japan
Contacts
Public ContactTetsuya Kawano
Nagasaki University Hospital Second Department of Internal Medicine
Outcome results
None listed