The purpose of this study is to compare the efficacy of Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg BID to Combivent® Inhalation Aerosol [2 inhalations from metered dose inhaler (MDI)of 18 mcg ipratropium bromide and 103 mcg albuterol sulfate QID], and to Compare the preference/compliance of BID nebulization to QID use of MDI

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2007

Intervention(s) in this Clinical Trial

• Drug: Formoterol Fumurate inhalation solution 20 mcg
• Drug: Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg

Primary Measures

• Lung function after 2 weeks of treatment

Secondary Measures

• Lung function at each time point, patient questionnaires, medication compliance,
• adverse events, clinical labs, vital signs, ECGs, physical exams

Inclusion Criteria:

• Diagnosis of COPD
• Smoker or exsmoker with at least 10 years smoking at least one pack of cigarettes per day
• Meet lung function requirements

Exclusion Criteria:

• Diagnosis of Asthma
• Significant disease other than COPD
• Female pregnant or lactating or planning to become pregnant

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dey

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00462540

Study ID Number: 201-081

ClinicalTrials.gov Identifier: NCT00462540

Health Authority: United States: Food and Drug Administration