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

Not Applicable

• Conditions: Asthma

• Registration Number: JPRN-UMIN000001288
• Lead Sponsor: Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka university Graduate school of medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-10-01
• Study Completion: 2009-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

Not provided

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"

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Asthma Control Test Asthma Quality of Life Questionnaire clinical and laboratory adverse experiences