A Crossover Study in the Treatment of Patients With COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00462540
• Other study ID #: 201-081
• Status: Completed
• Phase: Phase 3
• First received: April 17, 2007
• Last updated: March 3, 2009
• Start date: May 2007
• Est. completion date: October 2007

Study information

• Verified date: March 2009
• Source: Dey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Formoterol Fumurate inhalation solution 20 mcg

• Ipratropium bromide 18 mcg and albuterol sulfate 103 mcg

Locations

Country	Name	City	State
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Coeur d'Alene	Idaho
United States	Research Site	Denver	Colorado
United States	Research Site	Gaffney	South Carolina
United States	Research Site	Johnson City	Tennessee
United States	Research Site	Morgantown	West Virginia
United States	Research Site	Panama City	Florida
United States	Research Site	Pensacola	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	San Antonio	Texas
United States	Research Site	San Diego	California
United States	Research Site	Spartanburg	South Carolina
United States	Research Site	Spokane	Washington
United States	Research Site	Sunset	Louisiana
United States	Research Site	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Dey

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sutherland ER, Brazinsky S, Feldman G, McGinty J, Tomlinson L, Denis-Mize K. Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI. Curr Med Res Opin. 2009 Mar;25(3):653-61. doi: 10.1185 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung function after 2 weeks of treatment
Secondary	Lung function at each time point, patient questionnaires, medication compliance,
Secondary	adverse events, clinical labs, vital signs, ECGs, physical exams