Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD

A single center, open label, single dose study to demonstrate the pharmacodynamic
bioequivalence of the test and reference metered dose inhalers containing albuterol sulfate
or albuterol sulfate/ipratropium in adult patients with COPD.

Inclusion Criteria:

- Provide written informed consent

- Diagnosis of COPD as defined by the American Thoracic Society/European Respiratory
Society guidelines characterized by progressive airflow limitation associated with
abnormal inflammatory response of the lungs to noxious particles or gases primarily
caused by cigarette smoking.

- Have an established COPD clinical history, symptomatic with dyspnea, chronic cough,
chronic sputum production or wheezing. At Visit 1, FEV1/FVC ratio must be less than
0.70 or at least 10% less than the FEV1/FVC ratio determined by the predicted normal
value. FEV1 must be less than 70% of the predicted normal value and greater than 25%
of the predicted normal value.

- Must be using one or more inhaled bronchodilators for treatment of COPD at the time of
Visit 1.

- Current or former smokers, with a history of at least 10 pack-years of cigarette
smoking. Number of pack-years = (number of cigarettes per day/20) X (number of years
smoked).

- Willing, and in the opinion of the investigator, able to adjust current COPD therapy
as required by the protocol.

Exclusion Criteria:

- Current diagnosis of other respiratory disorder(s) including, but not limited to:
alpha-1-antitrypsin deficiency; lung cancer; cystic fibrosis; tuberculosis;
sarcoidosis; idiopathic pulmonary fibrosis; primary pulmonary hypertension; or
pulmonary thromboembolic disease. Patients with concomitant COPD and asthma will be
allowed to participate.

- Diagnosis of non-respiratory disorder(s) that are currently affecting lung function,
as determined by he principal investigator including, but not limited to: congestive
heart failure; symptomatic cardiac arrhythmia; symptomatic seizure disorder; dementia;
lupus; rheumatoid arthritis; or liver cirrhosis.

- Unable to abstain from protocol defined prohibited medications during the screening
and testing period.

- Unable to withhold short acting bronchodilators for 6 hours prior to spirometry
testing at the study visit.

- Unable to perform acceptable or repeatable spirometry or comply with other study
procedures.

- Known allergic reaction to albuterol sulfate or ipratropium bromide.

- Diagnosis of cancer that is not presumed to be in remission or cured.

- Active alcohol or drug abuse.

- Pregnant or lactating women. Pregnancy confirmed by a positive hCG test.

- Treatment with another investigational study drug in another clinical study within the
last 30 days or five half-lives, whichever is longer.