NIPH Clinical Trials Search

UMIN ID: UMIN000002263

Registered date:01/08/2009

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

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedbronchial asthma
Date of first enrollment2009/01/01
Target sample size300
Countries of recruitmentJapan
Study typeObservational


Primary Outcome1. 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 OutcomeFrequency in use of short-acting beta2-agonist(SABA)

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteriaPatients 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


public contact
Name Masamitsu Arai
Address 2-2-2 Nakanoshima, Kita-ku, Osaka, Japan Japan
Telephone 06-4716-3315
Affiliation MC&P Co., Ltd. Medical Sciences Marketing Division
scientific contact
Name Mitsuru Adachi
Address 1-5-8 Hatanodai, Shinagawa-ku, Tokyo 142-8555 Japan
Telephone 06-4706-3315
Affiliation Showa University The Division of Respiratory and Allergy, Department of Internal Medicine