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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00435760
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : November 17, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Aclidinium bromide Drug: Placebo Tiotropium Drug: Tiotropium Drug: Placebo LAS34273 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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).
Study Start Date : February 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Active Comparator: Tiotropium
1 puff, 1 day treatment
Drug: Tiotropium
1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00

Placebo Comparator: Placebo
Tiotropium or Aclidinium Placebo, 1 day treatment
Drug: Placebo Tiotropium
1 puff once daily, 1 day treatment

Drug: Placebo LAS34273
1 puff, 1 dat treatment

Experimental: Aclidinium bromide
200 micrograms, once daily, 1 day treatment
Drug: Aclidinium bromide
200 micrograms, once daily, 1 day treatment

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00435760

United Kingdom
Respiratory Clinical Trials Ltd
London, United Kingdom, W1G 8HU
Sponsors and Collaborators
Study Director: Esther Garcia, MD AstraZeneca

Additional Information:
Responsible Party: AstraZeneca Identifier: NCT00435760     History of Changes
Other Study ID Numbers: M/34273/24
2005-005804-17 ( EudraCT Number )
First Posted: February 15, 2007    Key Record Dates
Last Update Posted: November 17, 2016
Last Verified: November 2016

Keywords provided by AstraZeneca:

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action