Acute Effect of Inhaled Budesonide/Formoterol Combination Compared with Terbutaline on Airway Inflammation in Patients with Asthma

Not Applicable

• Conditions: To investigate the effects of budesonide/formoterol on acute anti-inflammation and lung function improvement in patients with asthma

• Registration Number: JPRN-UMIN000010811
• Lead Sponsor: Taipei Veterans General Hospital

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-02-10
• Study Start: 2013-05-27
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified