Study on the effects of the budesonide/formoterol combination formulation in improving airway inflammation and airway resistance in patients with bronchial asthma
Not Applicable
- Conditions
- Patients with bronchial asthma aged 20 years and older (males and females, outpatients and inpatients) being treated with an ICS (at a dose equivalent to FP 200-1000 mcg/day) and salmeterol 100 mcg/day in combination (either as two separate products or one combined product) for 3 months or longer with poor or inadequate control
- Registration Number
- JPRN-UMIN000006572
- Lead Sponsor
- Chiba-Hokusoh Hospital, Nippon Medical School
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients with infections with no available effective antimicrobial drugs or with deep mycosis. 2)Patients with a history of hypersensitivity(including contact dermatitis)to any ingredient contained in budesonide/formoterol. 3)Patients with tuberculous disease 4)5)Case with the following complications -Severe liver disease -Severe renal disease 6)Planning-to-be-pregnant,pregnant or lactating patients 7)Patients who are inappropriate considered by physician.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of various indicators 1)Fraction of exhaled Nitric Oxide 2)Mostgraph 3)Airway resistance of interrupter method
- Secondary Outcome Measures
Name Time Method Respiratory Function(FEV1) Improvement of ACQ(asthma control questionnaire)score Frequency of use of short-acting inhaled be-ta2 agonist(SABA) Number of adverse event