Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

This exploratory study will compare the efficacy of the fixed-dose combination (FDC) of aclidinium bromide and formoterol fumarate once daily in the morning and placebo once in the evening vs. the FDC once daily in the morning and formoterol fumarate once in the evening vs. formoterol fumarate twice daily. The study will assess pulmonary function and symptoms in patients with moderate to severe COPD.

Key facts

Study ID

NCT00706914

Run by

AstraZeneca

People needed

156

Starts

2008-06-30

Expected to finish

2008-11-11

Last updated by the study team

2017-05-15

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Moderate to severe COPD
• Smoking history of greater or equal to 10 pack-years
• Diagnosis of stable moderate to severe COPD as defined by the GOLD Guidelines
• Postbronchodilator FEV1 from 30% to 79% of predicted values, inclusive
• Postbronchodilator FEV1/FVC ratio < 0.70

You may not qualify if…

• History or presence of asthma, allergic rhinitis, or exercise-induced bronchospasm
• Hospitalization for an acute COPD exacerbation in the 3 months prior to study entry
• Respiratory tract infection (including the upper respiratory tract) or COPD exacerbation in the 6 weeks prior to study entry
• Eosinophil count of at least 600 cells/mm3
• Long term oxygen therapy > 15 hours a day

Where it is running

• Forest Investigative Site — Tucson, Arizona, United States
• Forest Investigative Site — Tucson, Arizona, United States
• Forest Investigative Site — Fullerton, California, United States
• Forest Investigative Site — Lakewood, California, United States
• Forest Investigative Site — Rancho Mirage, California, United States
• Forest Investigative Site — Redlands, California, United States
• Forest Investigative Site — San Diego, California, United States
• Forest Investigative Site — San Jose, California, United States
• Forest Investigative Site — Stockton, California, United States
• Forest Investigative Site — Wheat Ridge, Colorado, United States
• Forest Investigative Site — Hartford, Connecticut, United States
• Forest Investigative Site — New Britain, Connecticut, United States
• Forest Investigative Site — Waterbury, Connecticut, United States
• Forest Investigative Site — DeLand, Florida, United States
• Forest Investigative Site — Panama City, Florida, United States
• Forest Investigative Site — Tamarac, Florida, United States
• Forest Investigative Site — Tampa, Florida, United States
• Forest Investigative Site — Atlanta, Georgia, United States
• Forest Investigative Site — Austell, Georgia, United States
• Forest Investigative Site — Blue Ridge, Georgia, United States
• Forest Investigative Site — Bowling Green, Kentucky, United States
• Forest Investigative Site — Hazard, Kentucky, United States
• Forest Investigative Site — North Dartmouth, Massachusetts, United States
• Forest Investigative Site — Rochester, Minnesota, United States
• Forest Investigative Site — Florissant, Missouri, United States

Full record on ClinicalTrials.gov

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