COPD
Conditions
Interventions
Add on tiotropium (18microg, twice daily) to current medications or Add on salmeterol (50microg, twice daily) to current medications or Add on salmeterol /fluticasone (50/250 microg, twice
Sponsors
EACC (Ehime Asthma COPD Conference)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study if all of the following criteria are met: 1)Gender: Both 2)Age: >=40 3)outpatients 4)Both emphysema and non-emphysema 5) GOLD stage >= II (%FEV1<80%) 6)receiving long-acting bronchodilaotr (LAMA, LABA, ICS/LABA combination) as continuous use for greater than 3 months 7)have respiratory symptoms (cough, phlegm, breathlessness ) 8)able to comply with the requirements of the protocol
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: 1) have lung infection and unable to be eligible for inclusion based on investigator's judgment. 2)have experience of exacerbation within 3 months. 3) receiving combination therapy of tiotropium and ICS/LABA 4) there is a current diagnosis of asthma, in the opinion of the investigator 5)serious allergy to medicine 6)In the opinion of the investigator, there is safety concern if add-on medication to current therapy. 7) The investigator judge to exclude
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement of FEV1 Improvement of CAT total score | — |
Secondary
| Measure | Time frame |
|---|---|
| COPD symptom (cough, phlegm, breathlessness) Stratified analysis of baseline CAT score | — |
Countries
Japan
Outcome results
None listed