COPD
Conditions
Interventions
QVA-149 (long-acting beta2 agonists (LABA)/long-acting muscarinic receptor antagonists (LAMA)
Sponsors
Yamaguchi University
Eligibility
Sex/Gender
All
Inclusion 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 <0.70 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this trial is to investigate the change in PA over a 12-week in response to QVA-149 (long-acting beta2 agonists (LABA)/long-acting muscarinic receptor antagonists (LAMA)) therapy in patients with COPD. | — |
Countries
Japan
Contacts
Public ContactKazuto Matsunaga
Graduate School of Medicine, Yamaguchi University Department of Respiratory Medicine and Infectious Disease
Outcome results
None listed