Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD
Acute Bronchodilator Effect of Inhaled Albuterol Sulfate and Ipratropium Bromide in Patients With Stable COPD
The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test
 product to the reference product as measured by increases in FEV1.
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.