Open-label, single-center, randomized and parallel-group study to exmamine the effects of montelukast and ciclesonide on the peripheral airway inflammation in asthma using alveolar nitric oxide.

Phase 4

• Conditions: Bronchial asthma

• Registration Number: JPRN-UMIN000001083
• Lead Sponsor: Kyoto University Graduate School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-03-18
• Study Completion: 2010-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

1 Exacerbations of asthma within 1 months 2 Sensitized to the drugs used in this study 3 Pregnancy or lactation 4 Those who are considered inappropriate by physicians in charge.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fractional exhaled nitric oxide levels at 0, 4, 12 and 24 weeks. Values of impulse oscillometry at 0, 4, 12 and 24 weeks.

Secondary Outcome Measures

Name	Time	Method
Pulmonary function levels at 0, 4, 12 and 24 weeks. Scores of questionnaires at 0, 4, 12 and 24 weeks. Levels of inflammatory biomarkers in induced sputum at 0 and 24 weeks.