Study on the cutoff value of exhaled nitric oxide (eNO) for prediction of asthma control levels

UMIN ID: UMIN000002263

Registered date:01/08/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: bronchial asthma
• Date of first enrollment: 2009/01/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: 1. eNO (exhaled nitric oxide) 2. Asthma control levels (well-controlled / poor-controlled; determined by indices as below) -%FEV1.0 (forced expiratory volume in 1 second percentage) -Score of ACQ(Asthma Control Questionnaire) -Volatility of PEF (peak expiratory flow)
• Secondary Outcome: Frequency in use of short-acting beta2-agonist(SABA)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients with any of the following conditions are excluded: 1) Visited emergency room or were hospitalized due to exacerbation of asthma within 30 days prior to enrollment. 2) Treated with systemic corticosteroids within 30 days prior to enrollment. 3) Acquiring upper/lower respiratory tract infection within 30 days prior to enrollment. 4) Using inhaled corticosteroids solely or with long-acting beta2-agonists (LABAs) at a dosage that exceeds the approved one. 5) Complicating pulmonary diseases as follows: COPD, bronchiectasis, primary pulmonary cancer, connective tissue disease, pulmonary hypertension, and/or cystic disease of the lungs 6) Current smokers

Related Information

• Primary Sponsor: Showa University
• Source(s) of Monetary Support: Advanced Clinical Research Organization