Bronchial asthma
Conditions
Interventions
Subjects will take one sachet of carbocisteine granules (containing 500 mg of L- carbocisteine per sachet) three times daily after meals for 48 weeks.
Subjects will take one sachet of placebo granules
Sponsors
GAIA Study Research Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [Observation phase] - Males and females >= 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. - Patients who can receive the influenza vaccination during the study period - Patients whose treatment can be matched to the asthma control level - Patients who have a good understanding of the objectives of the study and who give written consent [Treatment phase] Patients who satisfy the following criteria in the observation phase: - Patients with satisfactory treatment adherence (Patients with a compliance rate >= 70% for each antiasthmatic drug) - Patients whose PEF measurements were performed at least 5 days/week - Patients who made asthma diary entries at least 5 days/week - Patients who satisfy the criteria for concomitant drugs and concomitant therapies in the observation phase
Exclusion criteria
Exclusion criteria: Patients to whom any of the following criteria apply will be excluded from the study: [Observation phase] Visit 1 - Patients with definite COPD - Patients who used continuously oral steroids or short-acting beta-2 receptor stimulants within one month prior to the observation phase (excluding cases when the drug was used to treat an exacerbation) - Patients who contracted a respiratory infection within one month prior to the observation phase - Patients who underwent hyposensitization therapy and used Omalizumab within three months prior to the observation phase - Patients with a reported adverse event related to carbocisteine - Patients with serious cardiac, hepatic, renal, pulmonary, or hematological disease - Patients who are pregnant or who are at risk of pregnancy - Patients with a malignancy - Other patients deemed unsuitable by the principal investigator or investigator According to The Global Initiative for Asthma (GINA) 2006, patients to whom the following apply: - 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): <80% predicted value For patients who experience three or more of the abovementioned conditions per week: - Exacerbation: >= 1/week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of exacerbation | — |
Countries
Japan
Outcome results
None listed