Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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.
 
ClinicalTrials.gov Identifier: NCT00435760
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE February 14, 2007
First Posted Date  ICMJE February 15, 2007
Last Update Posted Date November 17, 2016
Study Start Date  ICMJE February 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 16, 2016)
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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title  ICMJE 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease (COPD)
Intervention  ICMJE
  • Drug: Aclidinium bromide
    200 micrograms, once daily, 1 day treatment
  • Drug: Placebo Tiotropium
    1 puff once daily, 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
  • Drug: Placebo LAS34273
    1 puff, 1 dat treatment
Study Arms  ICMJE
  • Active Comparator: Tiotropium
    1 puff, 1 day treatment
    Intervention: Drug: Tiotropium
  • Placebo Comparator: Placebo
    Tiotropium or Aclidinium Placebo, 1 day treatment
    Interventions:
    • Drug: Placebo Tiotropium
    • Drug: Placebo LAS34273
  • Experimental: Aclidinium bromide
    200 micrograms, once daily, 1 day treatment
    Intervention: Drug: Aclidinium bromide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2011)
115
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00435760
Other Study ID Numbers  ICMJE M/34273/24
2005-005804-17 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Esther Garcia, MD AstraZeneca
PRS Account AstraZeneca
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP