Chronic obstructive pulmonary disease (COPD)
Conditions
Interventions
One inhalation (400 microgram as aclidinium) is administered with Genuair inhaler twice daily for 2 weeks
Two inhalations (5 microgram as tiotropium) are administered with Respimat inhaler once daily
Sponsors
Tohno-Chuo Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all the conditions below at Week 0 will be eligible as subjects. (1) Having provided written consent prior to participation in the study (2) Age more than 40 years (3) Having COPD with post-bronchodilator FEV1/FVC <70% within the past 3 months (4) Having smoking history more than 10 pack-years (5) No previous use of Genuair or Respimat (6) Having sufficient maniphalanx motor function for device operation (7) Capable of understanding the device operation sufficiently
Exclusion criteria
Exclusion criteria: Patients who meet any of the conditions below at Week 0 will not be selected as subjects. (1) Having evidence of bronchial asthma (2) Having serious respiratory, cardiac, digestive (hepatic, renal, or pancreatic), urinary, hematological, or renal disease or other serious concurrent medical condition that would interfere with participation in the study (3) Having deformity or paralysis of maniphalanx which, in the opinion of the principal investigator, will preclude an optimal operation of the study device (4) Cannot understand the inhalation procedure because of dementia, etc., in the opinion of the principal investigator (5) Having contraindication of anticholinergic agents (6) Having a history of adverse reactions to anticholinergic agents (7) Having malignant tumor or a history of malignant tumor within the past 5 years (8) Inadequate for the study, in the opinion of the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimal operation rate by investigator | — |
Secondary
| Measure | Time frame |
|---|---|
| Acquirement rate of inhalation procedure - Number of IPGs(inhalation procedure guidances) - Subject questionnaire using questionnaire on inhaler - Evaluation of pitfalls evaluated by investigator. - Dyspnea (mMRC questionnaire) | — |
Countries
Japan
Contacts
Public ContactNobuhide Mori
Mebix, Inc. Research promotion division
Outcome results
None listed