Evaluation of device operability of Genuair inhaler and Respimat inhaler in patients with chronic obstructive pulmonary disease (COPD)

Not Applicable

• Conditions: Chronic obstructive pulmonary disease (COPD)

• Registration Number: JPRN-UMIN000019373
• Lead Sponsor: Tohno-Chuo Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-22
• Study Completion: 2016-05-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Optimal operation rate by investigator

Secondary Outcome Measures

Name	Time	Method
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)