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.

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. - Study to examine the effects of montelukast and ciclesonide on the peripheral airway inflammation in asthma using alveolar nitric oxide.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001083

Enrollment

Registered

2008-03-18

Start date

2008-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchial asthma

Interventions

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 fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1 Never smoker or ex-smoker(< 5 pack-year) 2 Stable for more than 3 months under the treatment with inhaled corticosteroids. 3 No current usage of anti-leukotriene agents 4 Presenting high levels of alveolar NO

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Fractional exhaled nitric oxide levels at 0, 4, 12 and 24 weeks. Values of impulse oscillometry at 0, 4, 12 and 24 weeks.	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactHisako Matsumoto

Kyoto University Graduate School of Medicine Department of Respiratory Medicine

075-751-3830

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026