Association of changes in dyspnea, lung function, and physical activity by Indacaterol/Glycopyrronium combination in patients with COPD - Changes in lung function and physical activity by LAMA/LABA therapy in COPD

Matsunaga Kazuto0 sites45 target enrollmentDecember 27, 2018

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Not specified
Sponsor: Matsunaga Kazuto
Enrollment: 45
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

Despite improvement in dyspnea and airflow limitation, PA decreased.However, PA improved in 25% of cases, and this group weretypified by strong airflow limitation. The improvement of PA may require identification of individual influencing factors, and appropriate interventions to address these influencing factors.During the study period, there was a drastic change in social conditions due to the COVID-19 pandemic, which may have had a significant impact on this study as well.

Registry

who.int

Start Date

December 27, 2018

End Date

October 5, 2021

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Matsunaga Kazuto

Eligibility Criteria

Inclusion Criteria

•1\) Written informed consent must be obtained before any assessment is performed
•2\) Aged \>\=40 years with mild\-to\-moderate stable COPD
•3\) A post\-bronchodilator FEV1 of \>\=50% of the predicted normal, have a post\-bronchodilator FEV1 to FVC ratio of \<0\.7
•4\) Either current smokers or ex\-smokers with a smoking history of \>\=10 pack\-years
•5\) A modified Medical Research Council (mMRC) dyspnea scale grade of at least 1

Exclusion Criteria

•1\) Moderate\-to\-severe COPD exacerbation (requiring antibiotics, systemic steroids or hospitalization) within the 4 weeks before the screening
•2\) Requiring LABA and LAMA combination therapy
•3\) Requiring long\-term oxygen therapy
•4\) Requiring short\-acting beta2\-agonista (SABA) relief use of more than 8 puffs/day
•5\) Concomitant pulmonary disease including asthma (FeNO\<50ppb at baseline)
•6\) Any physical disorder that would prevent the patient from being able to complete the assessments
•7\) Long QT syndrome at screening, or a clinically significant electrocardiogram abnormality
•8\) History of closed angle glaucoma, and/or ischuria due to prostatic disease
•9\) There is a history of hypersensitivity to components of the Urutiburo