JPRN-UMIN000010811Completed未知
Acute Effect of Inhaled Budesonide/Formoterol Combination Compared with Terbutaline on Airway Inflammation in Patients with Asthma - Acute Effect of Inhaled Budesonide/Formoterol on Airway Inflammation in Asthma
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Enrollment
- 120
Study Overview
Brief Summary
The significant correlations between eosinophils and eNO and between neutrophils and IL-8 were observed at baseline. Six hours after dosing, total eosinophil counts, IL-8 and matrix metalloproteinase-9 were significantly decreased in the group of higher dose of budesonide/formoterol(vs. those with turbutaline group, P < 0.05). The increase in FEV1 in the group of higher dose of budesonide/formoterol was significantly higher comparing to other groups 3 3 hours after dosing. In the following 24 weeks, significant asthma control was achieved in terms of eNO, FEV1, and ACQ-5 4 weeks after treatment, and the improvement was sustained to the end of study.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 70years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
Exclusion Criteria
- •1.Patients take the following medications within 3 months prior to the study enrollment: •oral or inhaled glucocorticosteroid; •anti-inflammatory treatment; 2.Patients are hypersensitive to budesonide, formoterol, terbutaline or inhaled lactose; 3.Documented evidence of any respiratory infection within 4 weeks prior to enrolment; 4.Females who are lactating or pregnant; 5.Documented evidence of malignancy; 6.Participation in any other clinical trial or using any other investigational drug within 30 days of entry to this protocol; 7.Documented evidence of significant renal function impairment, severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV), or any finding through physical examination or medical history giving reasonable suspicion of a disease or condition that might render the subject at high risk from treatment.
Investigators
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