Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Tiotropium; Drug: Placebo LAS34273; Drug: Aclidinium bromide; Drug: Placebo Tiotropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00435760

2005-005804-17 (EudraCT Number)

M/34273/24

Details and patient eligibility

About

This trial evaluates the rate of onset of bronchodilator action of aclidinium bromide compared to placebo and tiotropium in patients with severe COPD after a single dose treatment.

Full description

This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.

Enrollment: 115 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females aged ≥ 40 years
• Current or ex-smokers of ≥ 10 pack-year
• Clinical diagnosis of severe stable COPD

Exclusion criteria

• History or current diagnosis of asthma, allergic rhinitis, or atopy
• Respiratory tract infection or acute COPD exacerbation in the last 6 weeks
• Hospitalised for an acute COPD exacerbation in the last 3 months
• Evidence of contraindicated use of anticholinergic drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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115 participants in 3 patient groups, including a placebo group

Tiotropium

Active Comparator group

Description:

1 puff, 1 day treatment

Treatment:

Drug: Tiotropium

Placebo

Placebo Comparator group

Description:

Tiotropium or Aclidinium Placebo, 1 day treatment

Treatment:

Drug: Placebo Tiotropium

Drug: Placebo LAS34273

Aclidinium bromide

Experimental group

Description:

200 micrograms, once daily, 1 day treatment

Treatment:

Drug: Aclidinium bromide