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Budesonide/formoterol combination therapy versus budesonide plus tulobuterol-patch therapy in elderly asthmatic patients: A randomized, comparative study

Not Applicable
Conditions
Bronchial Asthma
Registration Number
JPRN-UMIN000006551
Lead Sponsor
Second Department of Internal Medicine, Nagasaki University Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
50
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in the ACQ(asthma control questionnaire) score after 12 weeks
Secondary Outcome Measures
NameTimeMethod
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
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