Efficacy and Safety of Aclidinium Bromide at Two Dose Levels Versus Placebo Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Aclidinium bromide 200 μg bid; Drug: Aclidinium bromide 400 μg bid; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01001494

ATTAIN

M/34273/34

Details and patient eligibility

About

The main purpose of this study is to assess the long term bronchodilator efficacy, safety and tolerability of inhaled aclidinium bromide at two dose levels compared to placebo in COPD patients and the benefits of the product in disease-related health status, COPD symptoms and COPD exacerbations.

Enrollment: 828 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult male and female patients aged ≥40 with stable moderate to severe COPD (GOLD guidelines).
• Post-salbutamol (FEV1) < 80% and ≥30% of predicted normal value and Post-salbutamol FEV1/FVC < 70%.
• Current or ex-smokers of ≥10 pack-years.

Exclusion criteria

• Patients with no history or current diagnosis of asthma.
• No evidence of an exacerbation within 6 weeks prior to the screening visit.
• No evidence of clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities.
• No contraindication to use of anticholinergic drugs such as 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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828 participants in 3 patient groups, including a placebo group

Aclidinium bromide 200 μg bid

Experimental group

Description:

Aclidinium bromide 200 μg twice-daily via inhalation

Treatment:

Drug: Aclidinium bromide 200 μg bid

Aclidininum bromide 400 μg bid

Experimental group

Description:

Aclidinium bromide 400 μg twice-daily via inhalation

Treatment:

Drug: Aclidinium bromide 400 μg bid

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo