Efficacy and Safety of LAS 34273 in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease(COPD)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Aclidinium bromide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00358436

ACCLAIM II (Other Identifier)

CT000742 (Other Identifier)

M/34273/31

Details and patient eligibility

About

To evaluate the efficacy and safety of LAS 34273 compared to placebo in patients with moderate to severe COPD during one year of treatment.

Enrollment: 804 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females aged ≥ 40 years with a clinical diagnosis of moderate to severe stable COPD

Exclusion criteria

• History or current diagnosis of asthma, recent respiratory tract infection or acute COPD exacerbation, life expectancy of less than 1 year, known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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804 participants in 2 patient groups, including a placebo group

Aclidinium 200 μg once-daily

Experimental group

Description:

Aclidinium bromide 200 μg once-daily by inhalation

Treatment:

Drug: Aclidinium bromide

Placebo

Placebo Comparator group

Description:

Placebo by inhalation

Treatment:

Drug: Placebo