COPD
Conditions
Interventions
Inhalation of beta 2 agonist, indacaterol, 150ug Q.D. for 4 to 5 weeks, followed by additional inhalation of anti cholinergic agent, glycopyrronium 50ug Q.D. for another 4 to 5 weeks.
Sponsors
Division of Respiratory Medicine, Hokkaido University Graduate School of Medicine
Division of Respiratory Medicine, Department of Internal Medicine, Shiga University of Medical Science,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinically stable patients with moderate to severe COPD,who are 60 years of age or older and have smoking history or current smokers and stop smoking at the time of giving the consent to this study.. They all provide written, informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria: (1) Coexistence of other major pulmonary diseases such as asthma, bronchiectasis, pulmonary fibrosis, tuberculosis, and pulmonary cancer diagnosed by imaging modalities and/or laboratory findings. Asthma is excluded based on clinical history and/or laboratory findings, including levels of IgE and/or eosinophils in blood and/or sputum, but not based on reversibility of airflow limitation. (2) Those who can not adequately inhale beta 2 agonist and/or anti-cholinergic agent. (3) Those who have severe dysfunction in liver or kidney. (4) Those who have unstable cardiovascular disease or potentially fatal arrhythmia. (5) Those who have poor-controlled diabetes or hypertension. (6) Those who have glaucoma. (7) Those who have symptomatic prostate hypertrophy; however, they may be included if they are asymptomatic with pharmaco- therapy or post-surgery of TURP. (8) Those who are considered as inappropriate subjects for any reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the change in airway inner area before and after inhalation of long-acting beta 2 agonist. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the change in airway inner area before and after additional inhalation of anti-cholinergic agent. To assess pulmonary function parameters in parallel and to examine the relationship of the change in airway inner area with that of pulmonary function parameters. | — |
Countries
Japan
Contacts
Public ContactKaoruko Shimizu, M.D.
Hokkaido University Hospital First department of medicine
Outcome results
None listed