UMIN ID: UMIN000001007
Registered date:04/02/2008
The additive effects of Pranlukast in stable asthmatic patients with the regular use of FP/LABA combination drug (2) Open-label, randomized, and cross-over study
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| 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) | The first 4 weeks are treated with FP/LABA combination drug and Pranlukast. The second 4 weeks are treated with only FP/LABA combination drug. The first 4 weeks are treated with only FP/LABA combination drug. The second 4 weeks are treated with. FP/LABA combination drug and Pranlukast. |
Outcome(s)
| Primary Outcome | Peripheral airway inflammation in induced sputum (Eosinophils, ECP and Eotaxin) |
|---|---|
| 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 |
|---|---|
| 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 |
|---|---|
| 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 |