Clinical Trial to Assess Rate of Onset of Bronchodilator Action in Severe Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
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ClinicalTrials.gov Identifier: NCT00435760 |
Recruitment Status :
Completed
First Posted : February 15, 2007
Last Update Posted : November 17, 2016
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
Tracking Information | ||||
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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 |
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
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Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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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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 |
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Condition ICMJE | Chronic Obstructive Pulmonary Disease (COPD) | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 ) |
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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 |
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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 |