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Completed

NCT Number: NCT00435760

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Respiratory Clinical Trials Ltd

London, W1G 8HU, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aclidinium Bromide

Drug

200 micrograms, once daily, 1 day treatment

Placebo Tiotropium

Drug

1 puff once daily, 1 day treatment

Tiotropium

Drug

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

Placebo LAS34273

Drug

1 puff, 1 dat treatment

Primary outcomes

  1. FEV1 Percentage Increase

    Time frame: 30 minutes

    Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes

Secondary outcomes

  1. Normalised Area FEV1 AUC 0-3h

    Time frame: 0-3 hours

    Normalised area under the curve (AUC) 0-3 hours of FEV1 and change form baseline in FEV1 at 30 min

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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).

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Feb 15, 2007
Registry last updated
Nov 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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