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

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

Tracking Information

• First Submitted Date: February 14, 2007
• First Posted Date: February 15, 2007
• Last Update Posted Date: November 17, 2016
• Study Start Date: February 2007
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided

Current Secondary Outcome Measures (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: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
• 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).
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Chronic Obstructive Pulmonary Disease (COPD)

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 2, 2011): 115
• Original Enrollment: Not Provided
• Actual Study Completion Date: August 2007
• Actual Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00435760
• Other Study ID Numbers: M/34273/24; 2005-005804-17 ( EudraCT Number )
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: AstraZeneca
• Study Sponsor: AstraZeneca
• Collaborators: Not Provided

Investigators

• Study Director: Esther Garcia, MD; AstraZeneca

• PRS Account: AstraZeneca
• Verification Date: November 2016