Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
Add indacaterol on tiotropium treatment in COPD patients.
Add budesonide / formoterol on tiotropium treatment in COPD patients.
Sponsors
Division of Respiratory and Infectious Diseases, St. Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Smoking history of 10 pack-years or more Diagnosis of moderate-to-severe COPD Post bronchodilator FEV1 <80% predicted normal Post-bronchodilator FEV1 / FVC <70% Patients treated with tiotropium for more than 2 weeks
Exclusion criteria
Exclusion criteria: COPD with asthma Patients who are already treated with ICS or oral corticosteroid regularly Patients with a history of asthma Patients who have experienced a COPD exacerbation within the previous 8 weeks. Patients with uncontrolled cardiac diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in FEV1 at 24 hours post dose (trough) before and after 8 weeks treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvements in the data of spirometry and IOS at 24 hours post dose (trough) before and after 8 weeks treatment. CAT score, transition dyspnea index (TDI), MMRC Exacerbations. | — |
Countries
Japan
Contacts
Public ContactMasamichi Mineshita
St. Marianna University School of Medicine Division of Respiratory and Infectious Diseases
Outcome results
None listed