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.

UMIN ID: UMIN000001083

Registered date:18/03/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Bronchial asthma
• Date of first enrollment: 2008/03/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Add montelukast sodium 10mg (p.o) once daily to the current medication for 24 weeks
Add inhaled ciclesonide 400mcg once daily to the current medication for 24 weeks
Continue the current medication for 24 weeks

Outcome(s)

• Primary Outcome: 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: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Kyoto University Graduate School of Medicine
• Secondary Sponsor: None
• Source(s) of Monetary Support: Kyoto University Graduate School of Medicine,None