UMIN ID: UMIN000001006
Registered date:04/02/2008
The additive effects of Pranlukast in stable asthmatic patients with the regular use of FP/LABA combination drug –(1) Open-label, randomized and comparative study–
Basic Information
Recruitment status | Complete: follow-up complete |
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Health condition(s) or Problem(s) studied | Asthma |
Date of first enrollment | 2008/03/01 |
Target sample size | 50 |
Countries of recruitment | Japan |
Study type | Interventional |
Intervention(s) | Treatments with FP/LABA combination drug and Pranlukast for 4 weeks. Treatments with FP/LABA combination drug for 4 weeks. |
Outcome(s)
Primary Outcome | Peripheral airway inflammation in induced sputum (Eosinophils and ECP) |
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Secondary Outcome | 1.Asthmatic symptoms and QOL(AQLQ) 2.Pulmonary functions (PEF, FEV1, FEF50,FEF75) 3.Eosinophils in peripheral blood |
Key inclusion & exclusion criteria
Age minimum | 16years-old |
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Age maximum | Not applicable |
Gender | Male and Female |
Include criteria | |
Exclude criteria | 1.Past treatments with anti-LT drugs in the previous 3 months. 2.Past treatments with oral corticosteroids in the previous 2 weeks. 3.Chronic obstructive lung disease (COPD) and other respitatory disease. 4.Severe liver, kidney, heart , hematic and other diseases 5.Inappropriate patients from the doctor's viewpoint. |
Related Information
Primary Sponsor | JA Tohno Kousei Hospital |
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Secondary Sponsor | |
Source(s) of Monetary Support | None |
Secondary ID(s) |
Contact
public contact | |
Name | Hiroyuki Ohbayashi |
Address | 76-1, Toki-Cho, Mizunami City, Gifu Pref., 509-6101, Japan Japan |
Telephone | 0572-68-4111 |
ohbayasi@nn.iij4u.or.jp | |
Affiliation | JA Tohno Kousei Hospital Allergy and respiratory Medicine |
scientific contact | |
Name | Mitsuru Adachi |
Address | 1-5-8, Hatanodai, Sinagawa-ku, Tokyo Japan |
Telephone | 03-3784-8000 |
Affiliation | Showa University School of Medicine First Department of Internal Medicine |