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

• Status: Terminated
• Trial end date: 2008-11-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Bromides; Formoterol Fumarate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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