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

AstraZeneca

Status and phase: Terminated; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Once-daily formoterol fumarate; Drug: Twice-daily formoterol fumarate; Drug: Once-daily aclidinium/formoterol; Drug: Placebo to formoterol fumarate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00706914

LAC-MD-24

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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156 participants in 3 patient groups

Once-daily aclidinium/formoterol

Experimental group

Description:

Aclidinium bromide 200 µg/ formoterol fumarate 12 µg fixed-dose combination (FDC) once-daily in the morning, plus placebo once-daily in the evening

Treatment:

Drug: Placebo to formoterol fumarate

Drug: Once-daily aclidinium/formoterol

Morning aclidinium/formoterol plus evening formoterol

Experimental group

Description:

Aclidinium bromide 200 µg/formoterol fumarate 12 µg FDC once-daily in the morning, plus formoterol fumarate 12µg once-daily in the evening

Treatment:

Drug: Once-daily formoterol fumarate

Drug: Once-daily aclidinium/formoterol

Formoterol BID

Active Comparator group

Description:

Formoterol fumarate 12 µg twice-daily (BID)

Treatment:

Drug: Twice-daily formoterol fumarate