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Add-on effect of Montelukast therapy for uncontrollable asthma patients with inhaled corticosteroids : A open-label multicenter study

Add-on effect of Montelukast therapy for uncontrollable asthma patients with inhaled corticosteroids : A open-label multicenter study - Add-on effect of Montelukast therapy for uncontrollable asthma patients with inhaled corticosteroids

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000001288
Enrollment
30
Registered
2008-10-01
Start date
2008-08-01
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

Asthma

Interventions

Treatment for 8 weeks with montelukast 10 mg once daily

Sponsors

Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka university Graduate school of medicine
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Patients had the consent for the study 2) Patients have mild-to-moderate persistent asthma according to Japanese asthma guidelines in 2006 3) under 24 score of Asthma Control Test 4) Patients had used inhaled corticosteroids over 8 weeks.

Exclusion criteria

Exclusion criteria: 1) Patients with a history of hypersensitivity to montelukast 2) Patients on continuous therapy with oral corticosteroids 3) In-patients for asthma within one month prior to entry the study 4) Patients with complications that could affect the evaluation of efficacy, such as bronchiectasis. 5) Pregnant women and women suspected of being pregnant, breast-feeding women 6) Patients who physician judged "not eligible"

Design outcomes

Primary

MeasureTime frame
Exhaled breath condensate(IL-4, RANTES, IL-8, TNF-a, IP-10, TGF-b, H2O2, sICAM1, Leukotrienes, etc.) Respiratory function (peak expiratory flow)

Secondary

MeasureTime frame
Asthma Control Test Asthma Quality of Life Questionnaire clinical and laboratory adverse experiences

Countries

Japan

Contacts

Public ContactMitsuhiro Yoshida

Osaka university Graduate school of medicine Department of Respiratory Medicine, Allergy and Rheumatic Diseases

hiroyoshida@imed3.med.osaka-u.ac.jp06-6879-3831

Outcome results

None listed

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