Multicentric study of combination therapy of theophylline and tiotropium in COPD

UMIN ID: C000000367

Registered date:01/04/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic obstructive pulmonary disease (COPD)
• Date of first enrollment: 2006/01/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): After 4 weeks of administration of tiotropium, both oral theophylline(200-800mg/day) and tiotropium will be administerd for 4 weeks.

Outcome(s)

• Primary Outcome: Lung function test QOL (St George Respiratory Questionnaire)
• Secondary Outcome: Blood concentration of theophylline Induced sputum

Key inclusion & exclusion criteria

• Age minimum: 45years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients for whom theophylline or tiotropium is contraindicated Patients who have used other long acting bronchodilator, other xanthine, and inhaled corticosteroid within 1 month Patients with asthma Patients who need persistant oxygen therapy Patients with respiratory infection within 1 month Patients with severe hepatic, renal, heart, hematologic abnormality Patients with active tuberculosis or pulmonary sequelae of tuberculosis Patients with cancer within 2 years. (excluding basal cell carcinoma) Patients with cystic fibrosis and bronchiectasis Patients who are or could be pregnant In addition to the above exclusion criteria, patients judged to be inadequate to participate in this study by their physician

Related Information

• Primary Sponsor: Graduate school of biomedical sciences, Hiroshima university, department of molecular and internal medicine
• Source(s) of Monetary Support: Graduate school of biomedical sciences, Hiroshima university, department of molecular and internal medicine