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

Single Dose, Double-blind, Double-dummy, 3 Period Cross-over, Placebo Controlled Clinical Trial to Assess the Reate of Onset of Action of Inhaled Aclidinium Bromide 200µg Compared to Placebo and Tiotropium 18µg in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00435760

Enrollment

115

Registered

2007-02-15

Start date

2007-02-28

Completion date

2007-08-31

Last updated

2016-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD

Brief summary

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.

Detailed description

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

Interventions

DRUGAclidinium bromide

200 micrograms, once daily, 1 day treatment

DRUGPlacebo Tiotropium

1 puff once daily, 1 day treatment

DRUGTiotropium

1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00

DRUGPlacebo LAS34273

1 puff, 1 dat treatment

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
FEV1 Percentage Increase	30 minutes	Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes

Secondary

Measure	Time frame	Description
Normalised Area FEV1 AUC 0-3h	0-3 hours	Normalised area under the curve (AUC) 0-3 hours of FEV1 and change form baseline in FEV1 at 30 min

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026