Bronchial asthma
Conditions
Interventions
Carbocisteine
Placebo
Sponsors
Tohno Area Asthma Treatment Committee (TAT Com.) in Gifu Tohno Chou Clinic Tohno Kousei Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Observation phase Males and females more than 20 yrs (at time of consent) Outpatients Patients with mild or moderate persistent asthma (according to the classification of asthma severity) taking into account current treatment. Patients with at least one asthma exacerbation in the 12 months prior to the observation phase. Patients with a morbidity period of one yr or more prior to the observation phase. Patients who have not smoked for one yr or more prior to the observation phase. An unequivocal diagnosis of bronchial asthma.
Exclusion criteria
Exclusion criteria: Patients to whom any of the following criteria apply will be excluded from the study: 1)Patients with definite COPD 2)Patients who used continuously oral steroids or short-acting beta2 receptor stimulants within one month prior to the observation phase (excluding cases when the drug was used to treat an exacerbation) 3)Patients who contracted a respiratory infection within one month prior to the observation phase 4)Patients who underwent hyposensitization therapy and used Omalizumab within three months prior to the observation phase 5)Patients with a reported adverse event related to carbocisteine 6)Patients with serious cardiac, hepatic, renal, pulmonary, or hematological disease 7)Patients who are pregnant or who are at risk of pregnancy 8)Patients with a malignancy 9)According to The Global Initiative for Asthma (GINA) 2006, patients to whom the following apply: Exacerbation:1/week Daytime asthma symptoms:More than twice weekly Limitations on activities: Yes Nocturnal or early morning symptoms: Yes Use of a bronchodilator for asthmatic attack: More than twice weekly Respiratory function (FEV1.0):more than 80% predicted value For patients who experience three or more of the abovementioned conditions per week: 10)Other patients deemed unsuitable by the principal investigator or investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of inflammatory marker in induced sputum(eosinophil,ECP,SP-D,MMP-9/TIMP-1,TSLP) | — |
Secondary
| Measure | Time frame |
|---|---|
| IOS(R5,R20,R5-R20,X5,Fres) pulmonary function(FVC, FEV1.0, FEV1.0%, %FEV1.0) FeNO Asthma related QOL(ACT, AQLQ) | — |
Countries
Japan
Contacts
Public ContactHiroyuki Ohbayashi
Tohno Area Asthma Treatment Committee (TAT Com.) in Gifu Department of Respiratory and Allergy Medicine
Outcome results
None listed