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| ID | Type | Description | Link |
|---|---|---|---|
| 2005-005804-17 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tiotropium | Active Comparator | 1 puff, 1 day treatment |
|
| Placebo | Placebo Comparator | Tiotropium or Aclidinium Placebo, 1 day treatment |
|
| Aclidinium bromide | Experimental | 200 micrograms, once daily, 1 day treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclidinium bromide | Drug | 200 micrograms, once daily, 1 day treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 Percentage Increase | Percentage of patients achieving a FEV1 increase from baseline equal to or greater than 10% at 30 minutes | 30 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Normalised Area FEV1 AUC 0-3h | Normalised area under the curve (AUC) 0-3 hours of FEV1 and change form baseline in FEV1 at 30 min | 0-3 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Garcia, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Clinical Trials Ltd | London | W1G 8HU | United Kingdom |
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| Label | URL |
|---|---|
| Sponsor web site | View source |
| Co-Sponsor web site | View source |
| CSR Synopsis |
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| Placebo Tiotropium |
| Drug |
1 puff once daily, 1 day treatment |
|
| Tiotropium | Drug | 1 puff of 18 µg (22.5 µg tiotropium bromide monohydrate) in the morning between 8:00 and 10:00 |
|
| Placebo LAS34273 | Drug | 1 puff, 1 dat treatment |
|
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C542859 | aclidinium bromide |
| D000069447 | Tiotropium Bromide |
| ID | Term |
|---|---|
| D012602 | Scopolamine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
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