Efficacy, Safety and Tolerability of Two Fixed Dose Combinations of Aclidinium Bromide/Formoterol Fumarate, Aclidinium Bromide, Formoterol Fumarate and Placebo for 28-Weeks Treatment in Patients With Moderate to Severe, Stable Chronic Obstructive Pulmonary Disease (COPD)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC); Drug: Formoterol Fumarate; Drug: Placebo; Drug: Aclidinium bromide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01572792

LAC-MD-36

Details and patient eligibility

About

The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.

Enrollment: 921 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Completion of the treatment phase of the lead-in study, LAC-MD-31
• Written informed consent obtained from the patient before the initiation of any study specific procedures
• No medical contraindication as judged by the PI
• Compliance with LAC-MD-31 study procedures and IP dosing.

Exclusion criteria

• No specific exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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921 participants in 5 patient groups, including a placebo group

1

Experimental group

Description:

Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose

Treatment:

Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)

Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)

2

Experimental group

Description:

Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose

Treatment:

Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)

Drug: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)

3

Active Comparator group

Description:

Aclidinium bromide 400 μg

Treatment:

Drug: Aclidinium bromide

4

Active Comparator group

Description:

Formoterol Fumarate 12 μg

Treatment:

Drug: Formoterol Fumarate

5

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo