A Crossover Study in the Treatment of Patients With COPD

Condition(s) targeted: Chronic Obstructive Pulmonary Disease

Intervention: Formoterol Fumurate inhalation solution 20 mcg (Drug); Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Dey

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

Primary outcome: Lung function after 2 weeks of treatment

Secondary outcome:

Lung function at each time point, patient questionnaires, medication compliance,

adverse events, clinical labs, vital signs, ECGs, physical exams

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Research Site, San Diego, California 92120, United States

Research Site, Wheat Ridge, Colorado 80033, United States

Research Site, Denver, Colorado 80206, United States

Research Site, Pensacola, Florida 32504, United States

Research Site, Panama City, Florida 32405, United States

Research Site, Coeur d'Alene, Idaho 83814, United States

Research Site, Sunset, Louisiana 70584, United States

Research Site, Charlotte, North Carolina 28207, United States

Research Site, Portland, Oregon 97213, United States

Research Site, Spartanburg, South Carolina 29303, United States

Research Site, Gaffney, South Carolina 29340, United States

Research Site, Johnson City, Tennessee 37601, United States

Research Site, San Antonio, Texas 78205, United States

Research Site, Spokane, Washington 99204, United States

Research Site, Morgantown, West Virginia 26505, United States

Starting date: May 2007
Ending date: October 2007
Last updated: March 5, 2008