UMIN ID: UMIN000001918
Registered date:01/05/2009
Prevention of early asthma in childhood trial with pranlukast in Mie; PROACT-Mie
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Wheezing syndrome in infants |
| Date of first enrollment | 2005/11/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | pranlukast and as-needed beta agonists as-needed beta agonists |
Outcome(s)
| Primary Outcome | wheezing episodes during and after treatment with pranlukast |
|---|---|
| Secondary Outcome | rate of dropout because of persistent asthma symptoms |
Key inclusion & exclusion criteria
| Age minimum | 6months-old |
|---|---|
| Age maximum | 24months-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Wheezing due to congenital anatomical anomaly, wheezing due to mediatinal neoplasm, croup syndrome, foreign body in the airways, heart diseases, pneumonia, tuberculosis, administration of leukotriene receptor antagonists, cromolyns, anti-histamines, severe liver/renal/heart diseases |
Related Information
| Primary Sponsor | Study group of pediatric asthma in Mie prefecture |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Mie National Hospital |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yuki Yamamoto |
| Address | 357 Osato-kubota, Tsu, Mie, Japan Japan |
| Telephone | 059-245-6355 |
| fujisawa@mie-m.hosp.go.jp | |
| Affiliation | Mie National Hospital Department of clinical trials |
| scientific contact | |
| Name | Takao Fujisawa |
| Address | 357 Osato-kubota, Tsu, Mie, Japan Japan |
| Telephone | 059-245-6355 |
| Affiliation | Mie National Hospital Institute for clinical research |