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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00435760
First received: February 14, 2007
Last updated: November 16, 2016
Last verified: November 2016
February 14, 2007
November 16, 2016
February 2007
August 2007   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT00435760 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
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).
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.
This is a single dose, randomised, double-blind, double-dummy, 3 period cross-over, placebo controlled, multinational, multicentre trial.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
115
August 2007
August 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00435760
M/34273/24
2005-005804-17 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Esther Garcia, MD AstraZeneca
AstraZeneca
November 2016

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