Patients diagnosed with COPD in accordance to the GOLD guidelines
Conditions
Interventions
Aclidinium bromide Genuair inhaler 400 microgram as Aclidinium bromide is inhaled twice daily, in the morning (9:00-11:00) and at night (21:00-23:00) for 8 weeks
Tiotropium bromide HandiHaler in
Sponsors
Kamei Internal Medicine and Respiratory Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all the conditions below at Visit 1 will be eligible as subjects. (1)Having provided written consent (2)Age more than 40 years (3)Having COPD with severity 2-3 (moderate to severe), as classified according to the GOLD guidelines (4)Having FEV1/FVC value of <70% after bronchodilator inhalation, within the past year (5)Having FEV1 >= 30% and < 80% of the predicted value (6)Being well controlled by COPD medications except long-acting anticholinergic agents for more than 4 weeks (7)Having smoking history >= 10 pack-years
Exclusion criteria
Exclusion criteria: Patients who meet any of the conditions below at Visit 1 will not be eligible as subjects. (1)History and concurrent medical conditions -Having bronchial asthma -Having pulmonary fibrosis definitely diagnosed by CT or HRCT (high-resolution CT) -Having respiratory tract infection (including upper-airway inflammation) within the past 4 weeks -Having hospitalization due to acute exacerbation of COPD within the past 3 months -Having serious complications such as respiratory, cardiac, hepatic, renal, pulmonary, or hematologic disease or others that would interfere with participation in the study -Having malignant tumor or a history of malignant tumor within the past 5 years -Having contraindication of anticholinergic agents (2)Medications and therapies -Either or both of ICS and ICS/LABA agents has been switched or planned to be switched within the 4 weeks prior to patient enrollment during the run-in/treatment periods or planned to be switched Use of anticholinergic agents (inhaled, oral, etc.) -LABA has been switched or planned to be switched during the run-in period -Use of cholinesterase inhibitors -Use of systemic steroids* -Use of theophylline products* except for sustained-release oral theophylline products *Except for the treatment of COPD exacerbation -Patients under oxygen therapy for more than 15 hours a day -Patients whoes pulmonary rehabilitation program has been changed within the past 6 weeks -Patients under acute-phase pulmonary rehabilitation program -Patients under non-invasive ventilation -Patients having a history of side effects anticholinergic agents (3)Others -Patients who cannot use inhaler correctly -Patients who cannot perform a respiratory function test properly -Patients who hope to change their smoking habit -Women who are pregnant, lactating, or hoping to become pregnant during the study period -Patients who have been judged ineligible for the study by the investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1AUC | — |
Secondary
| Measure | Time frame |
|---|---|
| -Index of respiratory function test(FVC, FEV1, %FEV1, FEV1%, VC, IC) -FeN0 -Questionnaires (SGRQ, mMRC questionnaire, SOBQ, SF-8) -Activity level -Laboratory test (hsCRP value, number of eosinophils, number of neutrophils, WBC) -Frequency of COPD exacerbation -Correlation between questionnaires and FEV1AUC -Summary scores and subscales of SF-8 -Correlation between Activity level and COPD index | — |
Countries
Japan
Contacts
Public ContactNobuhide Mori
Mebix Inc. Research Promotion Division
Outcome results
None listed