Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Placebo; Drug: Aclidinium bromide; Drug: Tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01462929

M/34273/39

Details and patient eligibility

About

The aim of the present study is to evaluate the 24h bronchodilatory efficacy of inhaled aclidinium bromide 400 µg administered twice a day versus placebo and tiotropium bromide, respectively, after 6 weeks of treatment.

Enrollment: 414 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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414 participants in 3 patient groups, including a placebo group

Aclidinium bromide

Experimental group

Description:

Aclidinium bromide 400 µg administered twice per day during 6 weeks of treatment

Treatment:

Drug: Aclidinium bromide

Tiotropium

Active Comparator group

Description:

Tiotropium bromide 18 µg administered once per day during 6 weeks of treatment

Treatment:

Drug: Tiotropium

Placebo

Placebo Comparator group

Description:

Placebo comparator administered during 6 weeks of treatment

Treatment:

Drug: Placebo