Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
The study design is a random open-label crossover study. The subjects are divided into two groups at random for an accurate evaluation of the influence of the order of drug treatments with tiotropium
finally, the other group is treated with the combination of the two drugs (tiotropium + indacaterol) for 4 weeks.
Sponsors
Shinshu University School of Health Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We recruite symptomatic patients with stable COPD from the outpatient clinic of Shinshu University Hospital. COPD is diagnosed based on clinical history and symptoms and by the pulmonary function characterized by irreversible airflow limitation in accordance with the GOLD guidelines. All subjects had smoking-related COPD without alfa1-antitrypsin deficiency and had a smoking history of more than 30 pack-years.
Exclusion criteria
Exclusion criteria: The patients who have any history of asthma or asthmatic symptoms, walking disability, severe arrhythmia, or heart failure, those who have suffered from respiratory tract infection or exacerbation of COPD during the preceding three months, and those who have been treated with oral steroids and/or long-term oxygen therapy were excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dynamic lung hyperinflation | — |
Secondary
| Measure | Time frame |
|---|---|
| FEV1, lung volumes, airway resistance, respiratory impedance, walking distance evaluated by shuttle walking test, health status evaluated by a questionnaire of the COPD assessment test (CAT), activity of daily life (ADL) evaluated using the questionnaire of the pulmonary emphysema activity of daily life score (P-ADL). | — |
Countries
Japan
Contacts
Public ContactKeisaku Fujimoto
Shinshu University School of Health Sciences Department of Clinical Laboratory Sciences
Outcome results
None listed