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This study evaluated the effect of inhaled aclidinium bromide on exercise endurance and in reducing resting and dynamic lung hyperinflation in patients with moderate to severe COPD. It was 9 weeks in duration, consisting of; a 2-week run-in period, 6 weeks of double-blind treatment, and a 1-week follow-up phone call. All patients meeting the eligibility criteria were randomized to one of two treatment groups: aclidinium bromide or placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aclidinium | Experimental |
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| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aclidinium Bromide | Drug | Aclidinium Bromide, 200μg. Once daily oral inhalation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Exercise Endurance Time (ET) | Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds. | From baseline Week 0 (Visit 4) to Week 6 (Visit 6) |
| Measure | Description | Time Frame |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) | Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough). | Change from baseline (Visit 4) at Week 6 (Visit 6) |
| Trough Inspiratory Capacity (IC) |
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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 |
|---|---|---|---|---|---|---|
| Forest Investigative Site 2088 | Jasper | Alabama | 35501 | United States | ||
| Forest Investigative Site 0909 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21183326 | Derived | Maltais F, Celli B, Casaburi R, Porszasz J, Jarreta D, Seoane B, Caracta C. Aclidinium bromide improves exercise endurance and lung hyperinflation in patients with moderate to severe COPD. Respir Med. 2011 Apr;105(4):580-7. doi: 10.1016/j.rmed.2010.11.019. Epub 2010 Dec 22. |
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All demographic and baseline characteristics were analyzed descriptively just for the Safety population.
Patient recruitment occurred from July to October of 2007 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
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| ID | Title | Description |
|---|---|---|
| FG000 | Aclidinium | Aclidinium bromide, 200 micrograms, oral inhalation once per day. |
| FG001 | Placebo | Dose-matched placebo, oral inhalation, once per day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo |
| Drug |
Dose matched placebo, once daily oral inhalation. |
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Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough). |
| Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) |
| Functional Residual Capacity (FRC) | Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough). | Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) |
| Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio | Ratio of trough Inspiratory Capacity verses Total Lung Capacity. | Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) |
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Forest Investigative Site 0957 | Long Beach | California | 90822 | United States |
| Forest Investigative Site 0973 | Los Angeles | California | 90073 | United States |
| Forest Investigative Site 0887 | Los Angeles | California | 90095-1690 | United States |
| Forest Investigative Site 0988 | Sacramento | California | 95817 | United States |
| Forest Investigative Site 0885 | Torrance | California | 90502 | United States |
| Forest Investigative Site 2663 | Clearwater | Florida | 33756 | United States |
| Forest Investigative Site 1030 | Jacksonville | Florida | 32224 | United States |
| Forest Investigative Site 0974 | Pensacola | Florida | 32504 | United States |
| Forest Investigative Site 0980 | Atlanta | Georgia | 30342 | United States |
| Forest Investigative Site 0991 | Atlanta | Georgia | 30342 | United States |
| Forest Investigative Site 0987 | Austell | Georgia | 30106 | United States |
| Forest Investigative Site 2008 | Marietta | Georgia | 30060 | United States |
| Forest Investigative Site 0984 | Iowa City | Iowa | 52242 | United States |
| Forest Investigative Site 1080 | Topeka | Kansas | 66606 | United States |
| Forest Investigative Site 0898 | Baltimore | Maryland | 21224 | United States |
| Forest Investigative Site 0886 | Boston | Massachusetts | 02135 | United States |
| Forest Investigative Site 1029 | North Dartmouth | Massachusetts | 02747 | United States |
| Forest Investigative Site 0889 | Livonia | Michigan | 48152 | United States |
| Forest Investigative Site 2079 | Saint Charles | Missouri | 63301 | United States |
| Forest Investigative Site 2071 | Omaha | Nebraska | 68198-2465 | United States |
| Forest Investigative Site 0972 | Brooklyn | New York | 11229 | United States |
| Forest Investigative Site 0971 | Great Neck | New York | 11023 | United States |
| Forest Investigative Site 1114 | New York | New York | 10001 | United States |
| Forest Investigative Site 2665 | New York | New York | 10010-7436 | United States |
| Forest Investigative Site 2081 | Charlotte | North Carolina | 28207 | United States |
| Forest Investigative Site 0688 | Charlotte | North Carolina | 28262 | United States |
| Forest Investigative Site 0981 | Toledo | Ohio | 43614 | United States |
| Forest Investigative Site 1057 | Hershey | Pennsylvania | 17033 | United States |
| Forest Investigative Site 0888 | Philadelphia | Pennsylvania | 19140 | United States |
| Forest Investigative Site 0983 | Scranton | Pennsylvania | 18509 | United States |
| Forest Investigative Site 2072 | Charleston | South Carolina | 29406 | United States |
| Forest Investigative Site 1107 | Columbia | South Carolina | 29201 | United States |
| Forest Investigative Site 0979 | Columbia | South Carolina | 29203 | United States |
| Forest Investigative Site 1078 | Greenville | South Carolina | 29615 | United States |
| Forest Investigative Site 0900 | Spartanburg | South Carolina | 29303 | United States |
| Forest Investigative Site 0962 | Nashville | Tennessee | 37232-2650 | United States |
| Forest Investigative Site 1082 | Dallas | Texas | 75231 | United States |
| Forest Investigative Site 2058 | Dallas | Texas | 75246 | United States |
| Forest Investigative Site 0890 | Houston | Texas | 77030 | United States |
| Forest Investigative Site 0977 | Midvale | Utah | 84047 | United States |
| Forest Investigative Site 0968 | Edmonton | Alberta | T6G 2B7 | Canada |
| Forest Investigative Site 0960 | Kelowna | British Columbia | V1Y 1E4 | Canada |
| Forest Investigative Site 0905 | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Forest Investigative Site 0976 | Winnipeg | Manitoba | R2K 3S8 | Canada |
| Forest Investigative Site 0891 | Hamilton | Ontario | L8N 3Z5 | Canada |
| Forest Investigative Site 2204 | Ottawa | Ontario | K1Y4E9 | Canada |
| Forest Investigative Site 0969 | Windsor | Ontario | N8X 3V6 | Canada |
| Forest Investigative Site 2205 | Montreal | Quebec | H4J 1C5 | Canada |
| Forest Investigative Site 0893 | Ste-Foy | Quebec | G1V 4G5 | Canada |
| Forest Investigative Site 0943 | Saskatoon | Saskatchewan | S7N 0W8 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Aclidinium | Aclidinium bromide, 200 micrograms, oral inhalation once per day. |
| BG001 | Placebo | Dose-matched placebo, oral inhalation, once per day. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Gender | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Exercise Endurance Time (ET) | Exercise endurance time is defined as the time from the increase in work rate at 75% Wmax (watts) to the point of symptom limitation. The Wmax is defined as the highest work rate the patients were able to maintain for at least 30 seconds. | Missing data for patients who withdrew due to COPD exacerbations was imputed using the Worst Observation Carried Forward (WOCF) of all Endurance time (ET), while ETs that were missing for other reasons were imputed using the Last Observation Carried Forward (LOCF) method based on the last visit available. | Posted | Least Squares Mean | Standard Error | Seconds | From baseline Week 0 (Visit 4) to Week 6 (Visit 6) |
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| Secondary | Trough Forced Expiratory Volume in 1 Second (FEV1) | Change in trough Forced Expiratory Volume in 1 second. FEV1 was assessed at the end of the daily dosing interval (Trough). | The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF). | Posted | Least Squares Mean | Standard Error | L | Change from baseline (Visit 4) at Week 6 (Visit 6) |
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| Secondary | Trough Inspiratory Capacity (IC) | Change in trough Inspiratory Capacity. Inspiratory Capacity was measured as part of the spirometry procedures performed at each visit. IC was assessed at the end of the daily dosing interval (Trough). | The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF). | Posted | Least Squares Mean | Standard Error | L | Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) |
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| Secondary | Functional Residual Capacity (FRC) | Change in trough Functional Residual Capacity. FRC was assessed at the end of the daily dosing interval (Trough). | The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF). | Posted | Least Squares Mean | Standard Error | L | Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) |
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| Secondary | Inspiratory Capacity (IC)/Total Lung Capacity (TLC) Ratio | Ratio of trough Inspiratory Capacity verses Total Lung Capacity. | The Intent-to-Treat (ITT) population consisted of all patients in the Safety Population who had at least a baseline and one post-baseline assessment of the primary efficacy parameter. Missing values due to a premature discontinuation or patients who missed specific trial visits were imputed by Last Observation Carried Forward (LOCF). | Posted | Least Squares Mean | Standard Error | ratio | Change from baseline Week 0 (Visit 4) to Week 6 (Visit 6) |
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Adverse event data was collected from July of 2007 to December of 2008 at 52 study sites (42 sites in the United States and 10 additional sites in Canada)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aclidinium | Aclidinium bromide, 200 micrograms, oral inhalation once per day. | 2 | 86 | 16 | 86 | ||
| EG001 | Placebo | Dose-matched placebo, oral inhalation, once per day. | 3 | 95 | 18 | 95 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileitis | Gastrointestinal disorders | MedDRA 9.1 | Systematic Assessment |
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| Diverticulum | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
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| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
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| Chronic Obstructive Pulmonary Disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
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All data generated in this study will be the property of the Sponsor. An integrated clinical and statistical report will be prepared at the completion of the study.
Publication of the results by the Investigator will be subject to mutual agreement between the Investigator and the Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical | Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001991 | Bronchitis |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| D004646 | Emphysema |
| 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 |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C542859 | aclidinium bromide |
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| Male |
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| Canada |
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