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

UMIN ID: UMIN000001288

Registered date:01/10/2008

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Asthma
• Date of first enrollment: 2008/08/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Treatment for 8 weeks with montelukast 10 mg once daily

Outcome(s)

• Primary Outcome: 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: Asthma Control Test Asthma Quality of Life Questionnaire clinical and laboratory adverse experiences

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Male
• Exclude 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&quot

Related Information

• Primary Sponsor: Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka university Graduate school of medicine
• Source(s) of Monetary Support: Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka university Graduate school of medicine