Efficacy of Aclidinium Bromide Administered in Chronic Obstructive Pulmonary Disease (COPD) Patients

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Aclidinium bromide 400 μg bid; Drug: Tiotropium 18 μg once-daily; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00868231

M/34273/23

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy, safety and tolerability of multiple doses of inhaled aclidinium bromide in moderate to severe COPD patients.

Enrollment: 30 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: Crossover Assignment

Masking: Double Blind

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30 participants in 3 patient groups, including a placebo group

Aclidinium 400 μg bid

Experimental group

Description:

Aclidinium bromide 400 μg twice-daily by inhalation

Treatment:

Drug: Aclidinium bromide 400 μg bid

Tiotropium 18 μg once-daily

Active Comparator group

Description:

Tiotropium 18 μg once-daily by inhalation

Treatment:

Drug: Tiotropium 18 μg once-daily

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo