A prospective, randomized, single- blind, controlled study to investigate the effect of suplatast tosilate on early- stage idiopathic pulmonary fibrosis

UMIN ID: UMIN000001567

Registered date:25/12/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Idiopathic pulmonary fibrosis
• Date of first enrollment: 2008/11/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Observation with placebo
Treatment with suplatast tosilate

Outcome(s)

• Primary Outcome: Pulmonary function test
• Secondary Outcome: Six-minute walk distance Serum markers (KL-6,SP-D,SP-A) Radiological findings Subjective symptoms Safety

Key inclusion & exclusion criteria

• Age minimum: 50years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude criteria: 1. Patients who cannot carry out pulmonary function test 2. Patients whose causes for interstitial pneumonia are apparent. 3. Patients who participated in a clinical trial within the past three months 4. Patients who contraindicate for suplatast tosilate. 5. Patients who are judged to be unfit for the study by the investigator

Related Information

• Primary Sponsor: Hiroshima University Hospital, Department of Respiratory Medicine
• Secondary Sponsor: None
• Source(s) of Monetary Support: Department of Molecular and Internal Medicine,None