COPD
Conditions
Interventions
None listed
Sponsors
Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Included in the study were those in whom LABA (Serevent Rotadisk 50) therapy was replaced with ICS/LABA (Advair Diskus 250/50, fluticasone propionate 250g/salmeterol xinafoate 50 g) therapy after 4 weeks or more of LAMA/LABA therapy (LAMA, tiotropium bromide hydrate as Spiriva Respimat 2.5g; LABA, salmeterol xinafoate as Serevent Rotadisk50); those 40 years old or older diagnosed with COPD; those with a history of smoking or current smokers; those with a FEV1/FVC ratio of less than 70%; and those in whom any disease associated with airflow obstruction other than COPD can be ruled out.
Exclusion criteria
Exclusion criteria: Excluded from the study were those with a documented history of asthma or a bronchodilator response (BDR) to 400g salbutamol shown as a FEV1 change of 200ml or more than 200 mL and those confirmed to have received LAMA, LABA or ICS other than the study drug or their combination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Airway resistance investigated with impedance-oscillation system (IOS) to clarify the effect of ICS as add-on to LAMA/LABA on airway lesions in COPD as well as its safety. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pulmonary function tests, SF36, COPD Assessment Test (CAT), and modified Medical Research Council scores investigated to clarify the effect of ICS as add-on to LAMA/LABA on airway lesions in COPD as well as its safety. | — |
Countries
Japan
Contacts
Public ContactYosuke Tanaka
Chiba-Hokusoh Hospital, Nippon Medical School Department of Respiratory Medicine
Outcome results
None listed