Actuation Indicator Trial in Patients With COPD

Inclusion criteria

• A diagnosis of COPD based on medical history at a severity to require maintenance treatment with a bronchodilator
• Male or female patients 40 years of age or older
• A smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
• Must be able to use the study MDI with the mouthpiece containing actuation indicator

Exclusion criteria

• Significant diseases other than COPD are excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study
• Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last three months. Patients with treated basal cell carcinoma are allowed
• History of asthma
• Significant history active alcohol or drug abuse
• Known active tuberculosis
• Known narrow-angle glaucoma
• Current significant psychiatric disorders
• Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices or diaphragm with spermicide, or Norplant®)
• Known hypersensitivity to anticholinergic drugs, any other component of the ipratropium bromide, HFA-134a or MDI components
• Previous participation in this trial
• Patients who are currently participating in another trial and/or who have received investigational drug within the past 30 days