Bronchial asthma
Conditions
Interventions
Symbicort group Two inhalations of Symbicort Turbuhaler 60, twice daily Treatment period (8 weeks)
Pulmicort group Two inhalations of Pulmicort 200&
g Turbuhaler 56 (or 112), twice daily Treatment period (8 weeks)
Sponsors
IAA Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [At start of observation period] 1) Patients who have not used ICS within 3 months before start of observation period 2) Patients who have not used LABA within 1 week before start of observation period 3) Patients presenting with "cough," "wheezing," "dyspnea," or any other symptom that suggests asthma, or those who are diagnosed with asthma by the investigator 4) Nonsmokers and patients who have not smoked for 1 year or longer (if patients have not smoked for 1 year or longer, those with a smoking history of 10 pack-year or more will not be included) 5) Patients aged 20 years or over at the time of informed consent 6) Patients who understand the content of the study and give written consent to participation in the study at their own will [At start of treatment period] The following inclusion criteria will be confirmed before start of treatment period: 1) Subjects diagnosed with asthma by the investigator during observation period 2) Subjects presenting with asthmatic symptoms once or more a week during observation period
Exclusion criteria
Exclusion criteria: [At start of observation period] 1) Patients with frequent nocturnal symptoms 2) Patients with limited daily activities 3) Patients who are judged to require oral steroid therapy to control asthmatic symptoms at start of observation period 4) Patients with %FEV1.0 less than 60% at start of period 5) Patients who have used steroid therapy (injection, oral preparation, intestinal infusion, or suppository) within 4 weeks before start of period 6) Patients who have started treatment with any leukotriene receptor antagonist within 2 months before start of period 7) Patients who have any coexisting respiratory infection including tuberculosis or acute upper respiratory tract inflammation/bronchitis, or those who have a history of such infections within 4 weeks before start of period 8) Patients who have any coexisting respiratory disease (COPD, pulmonary fibrosis, etc.) other than asthma 9) Patients with any serious cardiac, hepatic, renal, hematological disorder, or any other serious complication 10) Patients who have coexisting malignant tumor or a history of malignant tumor 11) Patients who have started new hyposensitization or nonspecific therapy within 3 months before start of period 12) Patients who are pregnant, lactating, possibly pregnant, or those who desire to become pregnant during their participation in the study 13) Others deemed unsuitable by the investigator 14) Patients who meet any of the contraindications described in the package insert of the study drug [At start of observation period] 1) Subjects with a body temperature of 37.5 degrees or above that suggests acute upper respiratory tract inflammation/bronchitis during observation period 2) Subjects who have used new asthma therapy other than the pretreatment drug during observation period 3) Subjects who have used steroid therapy (injection, oral preparation, inhalation, intestinal infusion, or suppository) during observation period 4) Others deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Achievement rate of "well-control" as defined by JGL2009 at 8 weeks after start of treatment period | — |
Secondary
| Measure | Time frame |
|---|---|
| (1)Efficacy endpoints - Achievement rate of "well-control" as defined by JGL2009 at 2 weeks after start of treatment period - Achievement rate of "well-control" as defined by GINA2006 at 2 and 8 weeks after start of treatment period - Daytime asthmatic symptoms - Nocturnal asthmatic symptoms and arousal - Limitation of activities - Frequency of use of short-acting inhaled beta 2 agonist (SABA) - %FEV1.0 - ACQ5 - Adherence - NO in breath - PEF (2) Safety endpoints - Adverse events - Adverse drug reactions | — |
Countries
Japan
Outcome results
None listed