Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
budesonide/formoterol 160/4.5 mcg, two inhalations twice a day
Sponsors
Department of Respiratory Medicine, Chiba-Hokusoh Hospital, Nippon Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged>=20years old 2) Diagnosed COPD 3) %FEV <=80%, CAT score >=20, or appropriate case considered by physician 4) Low peak inspiratory flow rate (30~60L/min.) 5) Provided written consent prior to enrollment
Exclusion criteria
Exclusion criteria: 1) Infections with no available effective antimicrobial drugs or with deep mycosis 2) A history of hypersensitivity (including contact dermatitis)to any ingredient contained in budesonide/formoterol 3) Tuberculosis 4) Case with the following complications a) Severe liver disease b) Severe renal disease 5) Planning-to-be-pregnant, pregnant or lactating patients 6) Inappropriate case considered by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of various indicators 1) Respiratory Function (FEV1,% FEV1) 2) CAT (COPD Assessment Test) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Airway resistance (R5, R20, R5-R20) Change of HADS (Hospital Anxiety and Depression Scale) Safety | — |
Countries
Japan
Contacts
Public ContactMitsunori Hino
Chiba-Hokusoh Hospital, Nippon Medical School Department of Respiratory Medicine
Outcome results
None listed