Open-label, single-center, randomized and parallel-group study to exmamine the effects of tulobuterol and salmeterol on the peripheral airway resistance in asthma.

UMIN ID: UMIN000001177

Registered date:06/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Bronchial asthma
• Date of first enrollment: 2008/06/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Add tulobuterol transdermal therapeutic system(TTS) 2 mg once daily to the current medication
Add inhaled salmeterol 50 mcg twice daily to the current medication

Outcome(s)

• Primary Outcome: Parameters of impulse oscillometry
• Secondary Outcome: 1. Indices of pulmonary function 2. Exhaled nitric oxide concentrations 3. degree of dyspnea (using Medical Research Council dyspnea scale) 4. Quality of life (using St. George's Respiratory Questionnaire) 5. ACT(asthma control test) 6. clinical symptoms(such as wheezing)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1. Patients with concomitant respiratory disease that may interfere with evaluation of outcomes 2. Patients with hypersensitivity to salmeterol or tulobuterol 3. Patients with dermal disease potentially intolerant to transdermal medication 4. Patients with hyperthyroidism or cardiovascular disease which preclude a use of beta-agonist 5. Pregnancy or lactation 6. Patients who are considered inappropriate by physicians in charge

Related Information

• Primary Sponsor: Kyoto University Graduate School of Medicine
• Source(s) of Monetary Support: Kyoto University Graduate School of Medicine