Verification of the significance of intervention with ICS/LABA combination therapy in patients with bronchial asthma without inhalation of ICS

Not Applicable

Recruiting

• Conditions: Bronchial asthma

• Registration Number: JPRN-UMIN000003724
• Lead Sponsor: IAA Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-08
• Study Completion: 2011-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement rate of "well-control" as defined by JGL2009 at 8 weeks after start of treatment period

Secondary Outcome Measures

Name	Time	Method
(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