Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients

Study Overview
=================
Brief Summary
-----------------
To investigate the dose response following single inhalation of Ba 679 BR inhalation powder in COPD patients using pulmonary functions as indicators, and to compare data obtained with overseas study findings

Official Title
-----------------
Dose Ranging Study of Ba 679 BR Inhalation Powder Following Single Inhalation in COPD Patients - Double-blind, Placebo-controlled, 4 Treatment, 4 Period Crossover Study-

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Ba 679 BR low dose
* Drug: Ba 679 BR middle dose
* Drug: Ba 679 BR high dose
* Drug: Placebo inhalation powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In a pulmonary function test of Screening Test II, FEV1.0 was less than 70% of predict normal and FEV1.0 was less than 70% of FVC. In the reversibility test of Screening Test II, FEV1.0 was improved by 10% or more at 1 hour after inhalation of 2 puffs of an anticholinergic agent (Tersigan ® Aerozol) History of smoking (< no. of cigarettes a day x no. of years of smoking > = 200 or more) 40 years of age or older Regardless of sex and the length of disease period Exclusion Criteria: A history of bronchial asthma A history of atopic disease, such as allergic rhinitis Blood eosinophil of 440/µl or more Continuous use of steroid drugs (oral administration, inhalation or injection) at a dose equivalent to over 5 mg daily of prednisolone A history of respiratory infection, including virus infection within 1 month before study initiation Tuberculosis, lung cancer or a history of pneumonectomy Glaucoma Under treatment of benign prostatic hypertrophy Hypersensitivity to anticholinergic agents or sympathomimetics Difficulty in expectoration of sputum Serious heart disease, renal disease, hepatic disease, endocrine disease or metabolic disease Use of any β blockers A history of myocardial infarction within the past 1 year A history of heart failure, cor pulmonale or arrhythmia requiring medication within the past 3 years A history of drug abuse or alcoholism Treatment of psychotic disease Pregnancy, possible pregnancy or lactation A history of participation in any other clinical studies within the past 6 months Judgment by the investigator that the patient is ineligible for inclusion in the present study

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ba 679 BR low dose<br> | Drug: Ba 679 BR low dose<br> <br> |
| Placebo Comparator: Placebo inhalation powder<br> | Drug: Placebo inhalation powder<br> <br> |
| Experimental: Ba 679 BR middle dose<br> | Drug: Ba 679 BR middle dose<br> <br> |
| Experimental: Ba 679 BR high dose<br> | Drug: Ba 679 BR high dose<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1.0 max (maximum forced expiratory volume in one second) |  | before and up to 24 hours after each study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1.0 AUC 0-24 (forced expiratory volume in one second as area under the curve 0 to 24 hours after administration) |  | before and up to 24 hours after each study drug administration | 
| FEV1.0 time to response |  | before and up to 24 hours after each study drug administration | 
| FEV1.0 Tmax (time to FEV1.0 max) |  | before and up to 24 hours after each study drug administration | 
| FEV1.0 at measuring time points up to 24 hours after administration of study drug |  | before and up to 24 hours after each study drug administration | 
| FVC AUC 0-24 (forced vital capacity as area under the curve 0 to 24 hours after administration) |  | before and up to 24 hours after each study drug administration | 
| FVC max |  | before and up to 24 hours after each study drug administration | 
| FVC at measuring time points up to 24 hours after administration of study drug |  | before and up to 24 hours after each study drug administration | 
| Occurrence of adverse events |  | up to 29 days | 
| Changes in blood pressure |  | before and up to 24 hours after each study drug administration | 
| Changes in pulse rate |  | before and up to 24 hours after each study drug administration | 
| Changes in transdermal O2 saturation |  | before and up to 24 hours after each study drug administration | 
| Abnormal findings in electrocardiogram (ECG) |  | before and 1.5 and 24 hours after each administration of study drug | 
| Abnormal changes in laboratory measurements |  | at 24 hours after last study drug administration | 
| Urinary excretion rate |  | before (from 4 hours pre-dosing until immediately before dosing) and 0-2, 2-4, 4-8, 8-12 and 12-24 hours after drug administration | 
| MMEF AUC 0-24 (maximal midexpiratory flow as area under the curve 0 to 24 hours after administration) |  | before and up to 24 hours after each study drug administration | 
| MMEF max |  | before and up to 24 hours after each study drug administration | 
| MMEF at measuring time points up to 24 hours after administration of study drug |  | before and up to 24 hours after each study drug administration |