Changes in lung function and physical activity by LAMA/LABA therapy in COPD

Phase 4

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: JPRN-jRCTs061180012
• Lead Sponsor: Matsunaga Kazuto

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.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-27
• Study Completion: 2021-10-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified